In-use Randomized, Cross-over, Controlled Double-blind Study of Four Different Tampons
Phase: NA
Conditions: Menstruation
Sponsor: Procter and Gamble

 
 
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AMENDMENT JANUARY 11, 2018 
Clinical Protocol  
CSD2017164 
 
In-use randomized, cross over, controlled, double-blind study of four different tampons  
 
 
PROTOCOL DATE 
NOVEMBER 30, 2017 
PRINCIPAL INVESTIGATOR 
 
DR. MICHAEL NOSS, MD. 
 
LOCATION OF THE STUDY: 
 
RADIANT RESEARCH 
         8250 KENWOOD CROSSING WAY STE 100 
    CINCINNATI, OH 45236 USA 
 
CLINICAL SECTION HEAD: 
ANN LAWRENCE, PH.D. 
PHONE:  513-945-0425 
 
CLINICAL SCIENTIST 
JAN STREICHER-SCOTT, PH.D., R.PH. 
PHONE: 513-634-5584 
 
 
STATISTICIAN 
LISA C. BOHMAN, MS 
PHONE:  513-626-7781 
 
CLINICAL TRIAL MANAGER 
 
 
STACEY CARPENTER 
PHONE: 513-307-3221 
 
CLINICAL DATA MANAGER 
 
GAIL KAPPLER 
PHONE:  513-622-2413 
 
TOXICOLOGIST: 
KAREN ACUFF, PH.D 
PHONE:  513-698-6275 
 
REGULATORY: 
KATHLEEN BLIESZNER, PH.D 
PHONE:  513-634-3168 
 
                             MICROBIOLOGIST: 
 
YULI SONG, PH.D. 
PHONE: 513-622-4861 
 
 
SPONSOR 
 
THE PROCTER & GAMBLE COMPANY 
WINTON HILL BUSINESS CENTER  
6280 CENTER HILL ROAD 
CINCINNATI, OH   45224 
 
 
 
 
 
 
 
 
 
 
 

 
 
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TABLE OF CONTENTS  
1.0  
Introduction 
9 
 
2.0 
Study Objectives 
9 
3.0 
Investigational Plan 
9 
  3.1 
Study Design 
9 
    3.2 
Selection of Study Population 
 
 
 
 
 
 
 
            9 
3.2.1 
Inclusion Criteria 
10 
3.2.2 
Exclusion Criteria 
11 
3.2.3 
Continuance Criteria 
 
12 
3.3 
Study Procedures  
 
12 
3.4 
Removal of Subjects from the Study 
16 
3.5 
Concomitant Therapy 
16 
3.6 
Treatments 
 
 
 
 
 
 
 
                                       16 
3.6.1 
Method of Assigning Subjects to Treatment Groups 
16 
3.6.2  
Treatments Administered 
16 
3.6.3 
Identity of Study Products 
17 
3.6.4 
Management of Study Products 
17 
3.6.5 
Blinding 
18 
3.6.6 
Breaking the Blind 
18 
    3.7      Measurement, Assessment, and Sample Collection 
18 
3.7.1 
Evaluation Assessments 
18 
3.7.2 
Safety Assessments 
18 
3.7.3 
Sample Collections 
19 
4.0 
Statistical Methods 
20 
4.1      Analysis Population 
20 
4.2      Determination of Sample Size 
20 
4.3      Method of Assigning Subjects to Treatment 
20 
4.4      Statistical Analysis Plan 
21 
5.0 
Investigator Obligation 
21 
 5.1 
Institutional Review 
21 
5.2 
Protocol Amendment 
 
 
 
 
 
 
 
 
          21 
5.3 
Subject Consent 
22 
5.4 
Data Collection  
 
 
 
 
 
 
 
 
          22 
5.4.1       Electronic Case Report Form 
 
 
 
 
 
 
 
          22 
5.4.2       Source Documents 
 
 
 
 
 
 
 
 
          23 
5.5 
Adherence to Protocol 
 
 
 
 
 
 
 
 
          23 
5.6 
Adverse Events 
23 
5.6.1 
Adverse Event Reporting 
24 
5.6.2 
Serious or Unexpected Adverse Event Reporting 
26 
5.7 
Records Retention 
26 
5.8 
Publications 
27 
6.0 
Study Management 
27 
6.1 
Data Quality Assurance 
27 
6.1.1 
Monitoring 
27 
6.2 
Study Termination 
27 
6.3 
Investigator's Final Report 
28 
 
 
 
 
 
 

 
 
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Appendices: 
Appendix 1 
 
Schedule of Study Procedures 
Appendix 2 
 
Risk Assessment 
Appendix 3 
 
Gynecological History (sample) 
Appendix 4 
 
Vaginal Health General Procedures 
Appendix 5 
 
Erythema Grading Scale 
Appendix 6 
 
Vaginal Examination 
Appendix 7 
 
Vaginal Assessment 
Appendix 8 
 
STI Microbiology Screening 
Appendix 9 
 
Vaginal Swabs for Microbiome Assessment 
Appendix 10 
 
Subjects Instructions (sample) 
Appendix 11 
 
Informed Consent (sample) 
Appendix 12 
 
Tampon Use Diary 
Appendix 13 
 
Monthly Post Menses Questionnaire 
 
 

 
 
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List of Abbreviations and Definition of Terms 
 
Abbreviation 
 
Definition 
AE 
 
Adverse Event 
BMI 
 
Body Mass Index  
CDM 
 
Clinical Data Management 
CRF 
 
Case Report Form 
CEF 
 
Closed Ended Flushable 
CPK 
 
Compak 
eCRF 
 
electronic case report form 
EDC 
 
Electronic Data Capture 
GCP 
 
Good Clinical Practice 
ICH 
 
International Conference on Harmonization 
IRB 
 
Institutional Review Board 
PAP 
 
Papanicolaou 
P&G 
 
Procter & Gamble 
SAE 
STI 
 
Serious Adverse Event 
Sexually Transmitted Infections 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Consultant Signature Page 
 
 
 
 

 
 
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Consultant Signature Page 
 
 

 
 
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Investigator Signature Page 
 
 
I have read and understand this protocol and concur with the study design.  I agree to 
participate as an Investigator and to follow the protocol as outlined.   
 
 
 
 
 
 
 
Michael Noss, MD 
Date 
 
  Investigator 
 
 
 
 
 
 
 

 
 
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 Sponsor's Representatives 
 
 
 This protocol has been approved by the Sponsor of the study. 
 
 
 
 
 
 
 
Jan Streicher-Scott, PhD, RP, H. 
Date 
 
Clinical Scientist/Project Leader 
 
 
 
 
 
 
 
 
Lisa C. Bohman, MS 
Date 
 
Statistician 
 
 
 
 
 
 
 
 
 
Stacey Carpenter 
Date 
 
 
 
 
Clinical Trial Manager 
 
 
 
 
 
 
 
Gail Kappler 
Date 
 
Data Manager 
 
 
 
 
 
 

 
 
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Clinical Study Protocol 
1.0 
Introduction 
Tampax tampons have been used for over 80 years as an internal method of absorbing 
menstrual flow.  Tampons are constructed of 100% cotton, 100% rayon, or blends of cotton and 
rayon.  They are manufactured with or without an overwrap and may be provided with a 
cardboard or plastic applicator for inserting the tampon into the vagina. 
The study involves normal menstrual use.  Prior experience has indicated that the study design 
described below effectively detects any differences between test products with a long history of 
safe (as labeled) use.  In addition, a questionnaire completed by the subjects, after product use, 
has been found to be a sensitive way of detecting any product-related sensations such as 
burning, stinging, irritation and comfort. 
2.0 
Study Objectives 
2.1 
Objective(s)   
 
1. The objective of this study is to support a claim of “clinically tested” while women wear 
tampon(s) during their full menstrual period with medical and gynaecological 
assessments of vaginal health and consumer self-reported assessments of comfort. 
2. To confirm the tolerability of four (4) tampon products based on a body of evidence 
associated with multiple assessments of vaginal health and adverse events. The primary 
conclusion will be derived from the clinical assessments including vaginal erythema, 
ulcerations, abrasions, vaginal pH, vaginal discharge, and Adverse Events (AEs).  
3. Usage diaries and questionnaires are added for learning purposes regards to comfort and 
tolerability. 
 
3.0 
Investigational Plan 
 
3.1 
Study Design 
This will be a 4-consecutive menstrual cycle, single center, randomized, controlled, double-
blind, crossover study conducted with approximately 100 menstruating women to complete with 
65. Women aged 18-55 who report having consistent menstrual cycles and who typically use 
tampons as their main source of feminine protection during their menstrual cycles.  Each subject 
will test each of the four (4) tampon products, testing one (1) product per monthly menstrual 
cycle over the course of this study.  The order of the products tested will be randomized for each 
subject. Subjects will be given a tampon use diary to be completed after the use of each tampon 
and a Monthly Comfort Questionnaire to be completed at the end of each menstrual cycle.  
Subjects will be instructed to call after the start of each period and schedule their gynecological 
examination visit within 72 hours after the use of their last tampon for each period.  Women who 
choose to use a backup menstrual protection product in addition to their assigned test tampon, 
will be provided currently marketed Always Ultrathin, Always Pantiliners and Always Overnight 
pads in the product’s marketed packaging.  Subjects will be given instructions, including to 
refrain from using any douche products, sexual lubricant (except lubricated condoms), vaginal 
medications, suppositories, feminine deodorant spray, powder (in the perineal area), or vaginal 
wipes at least 48 hours prior to the screening visit and for the duration of their study 

 
 
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participation.  Subjects will be given instructions to refrain from sexual activity for at least 48 
hours prior to every gynecological examination visit. Subjects will be asked to refrain from 
bathing and use of antibacterial soaps while on the study, and from any vaginal hair removal 12 
hours prior to the screening visit.  During the tampon use phase of the study, subjects will be 
queried for changes in their health and medications at every visit.  If during their monthly 
gynecological examination, a vaginal or pelvic organ associated adverse event is reported or 
found, if the subject wishes to continue in the study, the PI will make the continuance decision 
on a case by case basis after consultation with the Sponsor. 
 
3.2 
Selection of Study Population 
 
3.2.1 Inclusion Criteria 
 
To be considered eligible for enrollment into this study subjects must meet the following criteria: 
1) signed the Informed Consent; 
2) female, between 18 and 55 years of age; 
3) agree to practice abstinence or use an effective form of birth control (e.g. intrauterine 
device, oral contraceptives, contraceptive implants or injections, diaphragm with 
spermicide, cervical cap, or constant use of condom) for at least the past 4 months and 
willing to continue throughout the study or have had a tubal ligation or your partner has 
had a vasectomy at least 4 months before being enrolled in the study;  
4) be in generally good health without clinically significant disease as determined by 
investigator or designee based on medical history and vaginal exam;  
5) for at least the last 4 months, have a consistent menstrual cycle lasting 21-35 days with 
menstrual bleeding lasting at least 3 days’ duration; 
6) primarily use tampons for their feminine protection needs during their periods (may use 
provided pads and/or pantiliners as back-up to tampon);  
7) typically use Regular (6-9 grams) absorbency tampons for the majority of their period, 
8) wears tampons during menstruation with no history of abnormal discomfort; 
9) last pap smear was normal in the past 3 years or a normal pap with a negative HPV in 
the past 5 years (age 18-21 does NOT need a PAP if they have never been sexually 
active), per standard of care (per ACOG guidelines), (self-reported); 
10) agree to refrain from vaginal intercourse within 48 hours of each vaginal exam 
scheduled visit; 
11) agree to refrain from showering within twelve (12) hours or bathing within twenty-four 
(24) hours (1 day) of each visit (except Visit 2); 
12) agree to refrain from using douching substances, feminine hygiene products, and to not 
apply powders, perfumes, wipes, lotions, creams, or emollients to their genital area 48 
hours prior to the screening visit and through the completion of the study, if 
accepted to participate in the study; 
13) agree to refrain from taking anti-inflammatory, antihistamine and/or, steroid systemic 
and/or topical, (including new hormonal contraceptives) medications until they have 
completed the study (e.g. Advil, Motrin, Benadryl, etc.); 
14) agree to only use the tampons, pads and pantiliners supplied at each study visit for her 
menstrual protection while participating in this study; 
15) be willing and able to comply with the study requirements; 

 
 
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16) agree to complete all study questionnaires; 
17) agree to refrain from participation in other concurrent clinical research studies; 
18) agree to refrain from genital hair removal (e.g. waxing/shaving, etc.) while on the study;  
19) agree to refrain from using antibacterial body soap while on the study (e.g. safe guard) 
 
3.2.2 Exclusion Criteria 
 
Subjects will be excluded from the study if they meet any of the following criteria: 
1) have a menstrual abnormality with in the last 4 months (such as oligomenorrhea or 
amenorrhea); 
2) has had a vaginal delivery in the last 6 months; 
3) had vaginal surgery, perineal surgery, uterine surgery, miscarriage or abortion in the 
last 6 months; 
4) are pregnant (per urine pregnancy test at screening), or intend to become pregnant in 
the next 5 months; 
5) have a history of Toxic Shock Syndrome (TSS); 
6) have a history of heart valve replacement; 
7) have had an abnormal Pap in either of your last 2 Pap Smears;  
8) have taken steroids (systemic and/or topical), corticosteroids, antihistamines, and/or 
anti-inflammatories within the past seven days (excludes hormonal contraception); 
9) have a history of immunosuppressive drug therapy, chemotherapy, or radiation 
therapy; 
10) have uncontrolled and/or unstable diabetes (exception...stable dose of Diabetic medication 
for at least 6 months prior to enrollment) in the opinion of the Investigator; 
11) have a vulvar piercing; 
12) have a history of genital herpes; 
13) within the last 6 months have had endometrial disease/uterine fibroids with 
symptoms of heavy menstrual flow (super plus tampon absorbency use) and/or 
severe menstrual cramping; 
14) have you been diagnosed with a current medical condition which might compromise 
the immune system functions; including cancer, anemia, leukopenia, leukocyte 
function deficiency, malnutrition, or chemical dependence (e.g. opiates, marijuana 
etc.) (self-reported); 
15)  have clinically diagnosed genital warts, lesions, and/or vaginal infections (such as 
bacterial vaginosis (BV), Candida spp., Trichomonas vaginalis) at the screening 
visit;  
16) have clinically diagnosed active or vaginal infections (Chlamydia trachomatis and/or 
Neisseria gonorrhoeae) identified through lab results from the microbiological 
sample obtained at the screening visit;  
17) has urinary incontinence which causes subject to regularly use and saturate diapers 
or absorbent panties or pads more than 3 times a week over the last 4 months, or 
currently under treatment for a pelvic floor disorder (i.e., perineal floor re-education 
with vaginal probe within last 6 months); 
18) have history of or current diagnosis of AIDS/HIV, organ transplant, neoplasia, liver 
disease, renal disease, deep vein thrombosis, pulmonary embolism, haemophilia, 
neutropenia, autoimmune disease, major depression or any other medical condition, 

 
 
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which in the opinion of the Investigator would preclude study participation 
(exception...stable dose of Thyroid medication for at least 6 months prior to 
enrollment);  
19) currently using a vaginal probiotic therapy (self-reported); 
20) have participated in a clinical study with exposure to any investigational drug 
product within 30 days prior to this study; 
21) have a vaginal erythema grade of ≥2.0 and/or the presence of abrasions and/or 
ulcerations as determined by investigator, at the screening visit; 
22) have taken antibiotics or antifungals within last 4 weeks (Topical use of antibiotics 
or antifungals outside the perineal/genitourinary area is allowed at the discretion of 
the Investigator); 
23) have started a new hormonal birth control in the previous 4 months or plan changing 
hormonal birth control throughout the study period; 
24) currently experiencing bladder, uterine or rectal prolapse (investigator to verify at 
screening visit). 
25) history of led or laser vaginal therapy within last 6 months (self-reported). 
 
3.2.3 Continuance Criteria 
 
Subjects will be excluded from the study if they meet any of the following criteria, and that, as 
determined by the investigator, would unduly influence the study or the participant’s health with 
their continued participation: 
1) Has there been any change in the subjects’ health since their last visit; 
2) Has subject started or stopped taking any medications since their last visit; 
3) Has subject taken or applied exclusionary medications (anti-inflammatory, antihistamine, 
steroid) or made changes in the dosages of reported medications since the previous visit; 
If yes, record on CRF CONCOMITANT MEDS and contact the Sponsor 
4) Has subject used douche products, vaginal medications, suppositories, feminine 
deodorant spray, powder (in the perineal area), or vaginal wipes for the duration of your 
study participation; If yes, record on CRF COMMENTS and contact the Sponsor 
5) Has subject refrained from sexual activity for at least 48 hours prior to the examination 
visit; If no, record on CRF COMMENTS and contact the Sponsor 
6) Has subject only used supplied test products for menstrual protection; If no, please 
record on CRF COMMENTS and contact the Sponsor 
7) has subject refrained from genital hair removal (e.g. waxing/shaving, etc.)? 
 
3.3  
Study Procedures 
 
The complete schedule of study procedures is presented in tabular form in Appendix 1. 
 
Visit 1 (Screening)  
 
Subjects will be initially screened at Visit 1 per the inclusion/exclusion criteria approximately 2 
weeks prior to start of subject’s menstrual cycle.  To determine eligibility, the following will be 
obtained at the study site: 

 
 
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1. written informed consent; 
2. inclusion/exclusion criteria; 
3. urine pregnancy test; 
4. demographics;  
5. medical & gynecological history; 
6. medication history; 
7. weight and height; 
Prior to procedures involving the vulvovaginal area, please complete the following: 
8. Ask subject to empty bladder; 
 
9. Have subject disrobe from the waist down and wear a gown or drape sheet; 
 
10. Vaginal pH 
 
11. Speculum insertion; 
12. Vaginal assessment (Vaginal Discharge) (Appendix 7); 
13. vaginal swabs for Microbiome Assessment (Appendix 9);  
14. vaginal exam (Appendix 6); 
15. screening STI Microbiology Screening (Appendix 8). 
Order of vulvovaginal procedures is: 
• Vaginal pH  
• Vaginal Discharge Assessment 
• Vaginal Swabs for Microbiome Assessment  
• Vaginal exam 
• STI Microbiology Screening (screening visit 1 only) 
Following these procedures, the Investigator will determine if the subject has met the initial 
study eligibility requirements (pending laboratory results).  Those subjects who have met the 
criteria, to this point, will be instructed that they will be notified of their final eligibility to 
participate in the study after the Investigator has received and reviewed the laboratory results.  
The subjects who have not met the criteria, at this point, will be informed of their ineligibility to 
participate and this will end their participation. 
 
 

 
 
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Visit 2 (at least one day prior to start of next menstrual cycle) 
 
Subjects who have been found to be eligible to participate will be instructed to return to the study 
site at Visit 2 and complete the following procedures: 
 
1. medical history update; 
2. medication history update; 
3. continuance criteria; 
4. randomization to study product; 
5. provide subjects with instructions, diary and monthly questionnaire, and monthly tampon 
product (per randomization) to use for their next menstrual cycle (Cycle 1) for the 
completion of visit.  Subjects will also be given a supply of ultra-pads, overnight pads 
and pantiliners to use a menstrual backup for the provided tampons, if desired; 
 
Visit(s) 3– 5 (within 72 hours after last tampon use) 
 
Subjects will return to the study site at Visit(s) 3-5 and complete the following procedures: 
1. medical history update; 
2. medication history update; 
3. continuance criteria;  
4. collect all un-used tampons from prior visit; 
5. collect tampon use diary(s); 
6. collect monthly post menses questionnaire;  
Prior to procedures involving the vulvovaginal area, please complete the following: 
7. Ask subject to empty her bladder. 
 
8. Have subject disrobe from the waist down.   
 
9. Vaginal pH 
 
10. Speculum insertion 
11. vaginal assessment (vaginal discharge) (Appendix 7); 
12. vaginal swabs for Microbiome Assessment (Appendix 9)  

 
 
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13. vaginal exam (Appendix 6) 
14. AE assessment; 
15. provide subjects with instructions, questionnaires (diary and monthly) and monthly 
tampon product (per randomization) for the completion of visit (Cycle 2-4).  Subjects will 
also be given a supply of ultra-pads, overnight pads and/or pantiliners to use as menstrual 
backup for the provided tampons, if desired. 
Order of vulvovaginal procedures after above has been performed is: 
• Vaginal pH  
• Vaginal Discharge Assessment 
• Vaginal Swabs for Microbiome Assessment  
• Vaginal exam 
Subjects who have abnormalities or irritation identified during their vaginal examination 
(including vaginal erythema grades ≥ 2.0 and/or abrasions and/or ulcerations which are severe, 
as determined by the Investigator) may be scheduled for an additional examination at the 
discretion of the Investigator. Photos maybe taken of the test site area for significant findings at 
the discretion of the Investigator. 
 
Visit 6 (EXIT: within-72 hour after last tampon use) 
Subjects will return to the study site at Visit 6 and complete the following procedures: 
1. medical history update; 
2. medication history update; 
3. continuance criteria;  
4. collect all un-used tampons from prior visit; 
5. collect tampon use diary(s); 
6. collect monthly post menses questionnaire;  
Prior to procedures involving the vulvovaginal area, please complete the following: 
7. Ask subject to empty her bladder; 
 
8. Have subject disrobe from the waist down and wear a gown or drape sheet;   
 
9. Vaginal pH 
 
10. Speculum insertion 
11. vaginal assessment (vaginal discharge) (Appendix 7); 
12. vaginal swabs for Microbiome Assessment (Appendix 9)  

 
 
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13. vaginal exam (Appendix 6) 
14. AE assessment; 
15. Subjects has completed the study. 
Order of vulvovaginal procedures after above has been performed is: 
• Vaginal pH  
• Vaginal Discharge Assessment 
• Vaginal Swabs for Microbiome Assessment  
• Vaginal exam 
Subjects who have abnormalities or irritation identified during their vaginal examination (including vaginal 
erythema grades ≥ 2.0 and/or abrasions and/or ulcerations which are severe, as determined by the Investigator) may 
be scheduled for an additional examination at the discretion of the Investigator. Photos maybe taken of the test site 
area for significant findings at the discretion of the Investigator. If follow-up is needed, this examination should 
occur approximately 1 week following Visit 6 and will be used to confirm resolution of the identified abnormalities.  
At this follow-up visit, if the abnormalities or irritation have not resolved (including erythema grades ≥ 2.0 and/or 
abrasions and/or ulcerations which are severe, as determined by the Investigator), the Investigator may recommend 
further medical follow-up for the subject.   
 
3.4 
Removal of Subjects from the Study 
 
Subjects may be withdrawn from the study by the Investigator or Sponsor for any of the 
following reasons: 
 
• subject did not meet enrollment criteria (inclusion/exclusion criteria); 
• subject has an AE that warrants study discontinuation;  
• subject lost to follow-up during the study or voluntary withdrawals;  
• significant protocol deviation (e.g., study product noncompliance); 
• withdrawal at the Investigator’s discretion. 
If possible, any subject who is withdrawn from the study will have the reason for withdrawal 
documented in the subject’s source documents and/or appropriate CRF and, at the time of 
withdrawal, all exit procedures performed (i.e., procedures for Visit 6).  All subjects who do not 
complete the study will be required to return all un-used study products provided by the Sponsor.   
 
3.5 
Concomitant Therapy 
 
For excluded medications prior to study start and during the study, see the inclusion/exclusion 
criteria (Sections 3.2.1 and 3.2.2).  Subjects will be instructed to contact the study staff to report 
any changes in product usage during the study. 
 
At each visit, new concomitant medications or changes to current concomitant medications will 
be documented. 
 
Subjects will be instructed to only use the test products and pads and/or pantiliners which have 
been supplied for all of their feminine protection needs during their participation in the study.  
Subjects will be instructed to use their normal care practices except refrain from using douching 

 
 
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substances, feminine hygiene products, or applying powders, perfumes, wipes, or emollients to 
the genital area for at least 24 hours prior to the start of tampon use and during the study.  After 
completion of the study, the subjects may resume using douching substances, powders, 
perfumes, wipes, or emollients per their normal habits and practices 
 
3.6 
Treatments 
3.6.1 Method of Assigning Subjects to Treatment Groups 
 
 
Subjects will be assigned a 4-digit subject number (e.g., 1001, 1002, etc) at Visit 1 (screening).  
At Visit 2, eligible subjects will be randomly assigned a randomization number using a balanced 
computer-generated randomization supplied by the Sponsor to the site.  A unique randomization 
number (e.g., 101, 102,103, etc) will be assigned for each study product assigned to subjects. 
 
3.6.2  Treatments Administered 
 
At Visits 2-5, each subject who fulfilled all the entry criteria will receive one of 4 treatments 
along with a daily and monthly questionnaire for use until their menstruation is complete. 
Subject instructions will be given to each subject (Appendix 10).   
 
All study products will be provided by the Sponsor in a double-blind manner.  
 
The study product label for the treatment phase will contain the Study Number and a space 
where the Subject Number will be recorded by the study site prior to dispensing. The label will 
also contain the randomization number and a statement clearly identifying an investigational 
product and other information as dictated by internal regulatory requirements.  
 
3.6.3 Identity of Study Products  
During the initiation visit, the monitor will review procedures for the management of study 
product. Throughout the study, additional shipments of study treatments and supplies may be 
sent to the study center to assure a continuous supply to all study subjects. 
Details regarding the study products are as follows: 
 
Test Product(s) – Regular Absorbency (6 to 9 grams) 
Tampax Pocket Pearl Compak – Sourced from US – GCAS# 91069721 
Lily - 100% cotton fiber tampon – Sourced from US – GCAS# 91500859 
Tampax Compak –Sourced from Budapest - GCAS# 92321409 
Tampax CEF- Sourced from Budapest – GCAS# 94522993 
 
Back-up Pads/Liners 
Always Ultrathin 
Always Pantiliners 
Always Overnight 
 
 
 
 

 
 
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3.6.4 Management of Study Products 
 
The Investigator will have overall responsibility for the use of the study product.  Under no 
circumstances will the Investigator allow the study products to be used other than as directed by 
this protocol.  The Investigator or qualified study center designee(s) will provide a signed 
acknowledgment for receipt of the study products and a signed acknowledgment for return of 
study product containers and unused study product.  An accurate record of the dispensing of all 
study products must be maintained.  Upon completion or termination of the study, remaining 
study product and administration materials will be returned to the Sponsor, unless otherwise 
instructed by the Sponsor. 
 
Qualified study center designee(s) must receive study product deliveries, record the receipt, and 
assure that the study product is handled and stored safely and properly.  The invoice must be 
reconciled against the study product received.  Any extra/damaged study product will be 
destroyed at the study center or sent to the Sponsor for destruction as instructed and documented 
by the Sponsor. 
 
Copies of all invoices and dispensing records for the study product must be kept at the study 
center as part of required study documentation.  At the end of the study, the study center must be 
able to reconcile delivery records with records of study product received, dispensed, and 
returned.  Any discrepancies will be documented. 
 
Upon receipt and until dispensed, all study product should be securely stored at controlled room 
temperature (20°C - 25°C or 68°F-77°F with excursions allowed between 15°C - 30°C or 59°F-
86°F).  Temperature excursions should be infrequent and last less than 24 hours. 
 
 
3.6.5 Blinding 
This is a double-blind study with limited access to the randomization code. The study product 
codes will be controlled by the Sponsor.  The study treatment sequence each subject will receive 
will not be disclosed to the Investigator, other study center personnel, or other Sponsor 
representatives.   
 
Bag packaging will be identical for all study products.  All study products will be similar in 
appearance.  The study will be unblinded for analysis only after the database has been locked. 
Study treatment assignments will be revealed to the Investigator when the final clinical report is 
issued.  
 
3.6.6 Breaking the Blind 
 
If the blind is broken (e.g. for a subject who has an AE that warrants study discontinuation) it 
may be broken for only the subject in question.  The Sponsor must be notified immediately if the 
Investigator/designee is unblinded during the course of the study.  Pertinent information 
regarding the unblinding of a subject’s treatment code must be documented in the subject’s 
source documents and the eCRF.  

 
 
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3.7 
Measurement, Assessment, and Sample Collection  
 
3.7.1 Evaluation Assessments 
 
Data from this study will be collected through multiple assessments.  These include: 
• Questionnaires (per use and monthly) 
• Vaginal assessment (discharge and pH) 
• Clinical Vaginal exam (vaginal exam) 
 
3.7.2 Safety Assessments 
 
Subject safety will be assessed with vaginal exams, at screening and at various time points 
throughout the study.   
 
Safety assessments will also include the collection of AEs reported by the subjects or observed 
by the investigator or study center personnel.  Subjects should be asked whether, since the time 
of the last observation or visit, they had any of the following: 
• experienced any changes in well-being, 
• used any new medications or supplements,  
• changed medication regimens (both prescription and non-prescription), or 
• been hospitalized or had any accidents.   
 
Questions should be of a general nature and should not suggest symptoms.  
 
When an AE is suspected, all relevant evaluations will be carried out and appropriate treatment 
provided.  Additional follow-up will be performed as necessary, recorded in the subject’s source 
documents, with the results provided to the Sponsor.  Subjects who experience any clinically 
significant AE will remain under medical supervision until the Investigator deems the AE to be 
resolved, stabilized, or no longer serious enough to warrant follow-up.  Laboratory values that 
are abnormal (whether or not they are assessed as AEs) may be followed at the discretion of the 
Investigator until resolved or stabilized.  
 
For AE definitions and reporting requirements, refer to Section 5.6. 
 
3.7.3 Sample Collections 
 
pH samples for evaluations will be obtained at Visit 1(screening) and Visits 2 thru 6.  These will 
be collected and processed according to instructions (Appendix 7) 
 
Microbiome samples will be collected at Visit 1 (Screening) and Visits 3, 4, 5 and 6. These will 
be collected and processed according to instruction (Appendix 9). A vaginal microbial swab will 
be collected for the purpose of assessing the vaginal microbial community of the study 
population.  Analyses will be coordinated by Procter & Gamble’s Microbiology Group and is not 

 
 
   CSD2017164 
 
20 
 
considered part of the clinical objectives of this study.  Only microbial DNA analysis will be 
conducted.  No human DNA analysis will be performed.   
 
Samples will be collected using only the 4-digit subject # in keeping with Good Clinical 
Practices.   
 
Samples will be stored in a -70˚Celsius freezer at the Procter & Gamble Micro Lab for a 
maximum of 5 years, after which, all specimens will be destroyed per P&G’s policy for 
specimen destruction.   
 
The results of this testing will not result in a commercially valuable product.   
 
Subjects may withdraw their consent to participate in this testing or to have her samples used for 
analysis.  The Microbiologist will destroy the samples collected from the subject and will delete 
any data collected from the analysis of the samples.   The microbiologist will document this 
process for the Study File.   
 
Testing does not have any clinical, diagnostic or therapeutic implications for the individual 
subjects.  Therefore, the results will not be reported to the Investigators, the subjects or their 
primary care physicians.  There will not be any follow-up with the subjects regarding this 
testing”. 
 
4.0 
Statistical Methods 
 
4.1      Analysis Population 
 
The Intent-to-treat (ITT) population is defined as all eligible subjects who are enrolled into the 
study, randomized to treatment, and are given their assigned test products for use.  The Per-
protocol (PP) population is defined as all subjects in the ITT population who are compliant with 
the study protocol and complete all four months of the study.  Given the duration of the study 
and likelihood of some panelist drop-out, analyses will be performed on both the ITT and PP 
populations.  
 
4.2      Determination of Sample Size 
 
As the prior data that is available is years old on the treatments in this study, the sample size of 
65 subjects was determined using clinical results based on expert judgment related to relevant 
publications/past clinical studies.   
 
4.3      Method of Assigning Subjects to Treatment 
 
Subjects will be randomly assigned to one of 4 treatment sequences using an encoded program 
supplied by the Sponsor. 
 
4.4      Statistical Analysis Plan 
 

 
 
   CSD2017164 
 
21 
 
No formal hypothesis testing is planned.  Product Acceptance will be assessed by 
medical/clinical with regards to the tolerability of the four treatments based on a body of 
evidence associated with multiple assessments of vaginal health and adverse events. The primary 
conclusion will be derived from the clinical assessments including vaginal erythema, ulcerations, 
abrasions, vaginal pH, vaginal discharge, and AE’s. 
 
Prior to statistical analysis, all data will be checked for accuracy, completeness and compliance 
to protocol.  Analyses will be completed using PC SAS Release 9.4.   
 
Demographic data will be summarized in tables of descriptive statistics by treatment sequence 
to assess overall balance between assigned sequences.   
 
Summary descriptive statistics will be provided for all parameters. Confidence intervals (95% 
Confidence intervals) will be constructed for all clinical assessments for each treatment code.  
Any data reported as ‘unable to evaluate’ will be treated as missing and excluded from the 
analysis. 
 
The frequencies of vaginal discharge color and consistency responses will be tabulated for each 
visit/treatment. Depending on the distributions, categories may be collapsed prior to statistical 
analysis.  The frequencies for normal vs. abnormal classifications will be tabulated per 
visit/treatment. Ninety-five percent CIs around the proportion with abnormal classification, and 
corresponding odds ratios will be constructed. 
 
The frequencies of erythema scores will be tabulated for each visit/treatment. Also per 
visit/treatment, 95% CIs will be constructed around: (1) the proportion of subjects with 
erythema, and (2) the proportion of subjects with moderate or severe erythema. CIs for the 
corresponding odds ratios also will be constructed. 
 
The frequencies for abrasion and ulceration will be tabulated for each visit/treatment. For each of 
these parameter, 95% CIs around the proportions and odds ratios will be constructed. 
 
Additional analyses may be conducted to further understand the data. 
 
5.0 
Investigator Obligation 
 
This study will be conducted in accordance with the applicable GCPs, International Conference 
on Harmonization (ICH) Good Clinical Practice. The Principal Investigator will perform or 
directly supervise the performance of all the services described herein, or incidental to those 
described herein, in accordance with the highest standards of medical and clinical research 
practice.  Delegation of any study responsibility will be documented in writing.  The Investigator 
will also be required to submit a report documenting study execution. 
 
5.1 
Institutional Review 
The study will not begin prior to the receipt of written confirmation of approval by the IRB and 
any relevant regulatory authority.  It is the responsibility of the Investigator to obtain the IRB 
approval (per the U.S. Code of Federal Regulations, Title 21, Part 56 and applicable ICH 

 
 
   CSD2017164 
 
22 
 
guidelines) for the protocol, amendments, informed consent, subject information sheet, 
questionnaires, and advertising materials used to recruit study subjects, if appropriate.  A copy of 
the IRB approval letter along with a list of the IRB members who acted on this protocol and a 
statement that the IRB is in compliance with current ICH E6 and Good Clinical Practices (GCP) 
guidelines will be provided to the Clinical Trial Manager. 
It is the Investigator’s responsibility to promptly report to the IRB all changes to the research 
activity and all unanticipated problems involving the risk to human subjects.   
5.2 
Protocol Amendment(s) 
With the exception of emergency situations, implementation of any significant change in the 
protocol (i.e., one that affects the safety of the subjects, scope of the investigation, or the 
scientific quality of the study) will not be permitted until the Sponsor, the Investigator, and the 
IRB have reviewed, approved, and documented the protocol amendment in writing.  
Amendments include changes in the study procedures, Investigator or site address, change risk 
level, etc. 
 
When a change is made to eliminate or reduce the risk to subjects, it may be implemented before 
review and approval by the IRB.  The Investigator shall notify the IRB of said change in writing 
within 5 working days after implementation. 
 
In the event of any emergency, the Investigator shall institute any medical procedures deemed 
appropriate.  However, all such procedures must be documented in writing and promptly 
reported to the Sponsor, the IRB, or other appropriate regulatory/government authority (if 
appropriate). 
 
Implementation of an administrative (minor or non-significant) change [e.g., changes in other 
Sponsor personnel (Clinical Data Manager, Statistician), IRB or Sponsor address, typographical 
errors, spelling errors, etc.] cannot be made until said change is reviewed and approved by the 
Sponsor and a memo communicating the change is provided to the Investigator.  Forwarding of 
these memos to the IRB by the Investigator should be based on the individual IRB instructions. 
5.3 
Subject Consent 
 
Each subject must sign and personally date a study-specific informed consent form to serve as a 
participant in the study.  This consent form will comply with all applicable regulations governing 
the protection of human patients.  The basic elements of informed consent are specified in the 
US CFR Title 21 parts 50.25, 50.27, and 50.55 and the ICH Harmonized Tripartite Guideline for 
GCP. 
 
The Investigator will obtain the IRB’s written approval of the written informed consent form to 
be provided to the subjects, including approval of all revisions.  Prior to the start of the study, the 
Investigator or an authorized staff member will inform patients about the nature of the study.  
Subjects will have the opportunity to inquire about details of the study and to decide whether to 
participate.  Subjects will be instructed that they are free to withdraw their participation in the 
study at any time without penalty or loss of benefits to which they are otherwise entitled.  The 

 
 
   CSD2017164 
 
23 
 
Investigator will inform subjects of new information that may be relevant to subjects’ 
willingness to continue participation in the study and the Investigator’s obligation to protect 
subject confidentiality. 
 
The Investigator will provide each subject with a copy of the signed and dated consent form and 
will document in the subject’s source notes that informed consent was given. 
5.4  
Data Collection 
The Investigator has the responsibility for ensuring that all source documents (i.e., study and/or 
medical records) and CRFs are completed and maintained according to the study protocol.  
Source documents and paper CRFs, where they exist, should be available at the site during the 
in-life portion of the study. 
5.4.1 Electronic Case Report Form(s) 
This study will utilize web-based, electronic case report forms (eCRFs) developed through a 
validated, Electronic Records/Electronic Signatures (ERES)-compliant platform (21 CFR 
Part 11), and all investigator data included in the study database will be collected in these eCRFs.   
Prior to the initiation of the trial, the study center will be contacted as to computer availability, 
hardware specifications, internet connectivity, etc., to evaluate their capacity to use this type of 
data capture system. Every person at the study center who will be entering data into this system 
will receive training on the system.  Each user will be issued a unique user identification and 
password. For security reasons, and to be in compliance with regulatory guidelines, it is 
imperative that only the person who owns the user identification and password enter the system 
using those user names and passwords. Passwords are not transferable. In the case of a change in 
study center personnel, the newly assigned individuals will be trained and a personal user 
identification and password will be provided. They may not use the identification and password 
of the previous user. 
Data changes, as well as the initial entry of data, into the eCRFs will be captured within the 
system’s audit trail. Included in the audit trail will be the item, the original value, the changed 
value, who made the change/entry, when the change/entry was made, and a reason for the 
change. 
During routine monitoring visits, the study center will make available to the monitor their 
computer and telecommunications that are suitable for Internet access so that the monitor may 
make a thorough crosscheck of the data entries with any source documentation.  
The Investigator will be responsible for the timeliness, completeness, and accuracy of the 
information on the eCRFs. Electronic consistency checks and manual review will be used to 
identify errors or inconsistencies. Errors or inconsistencies will be posted as queries in the 
eCRFs or in an excel spreadsheet for resolution. The study center must answer the queries within 
a reasonable, mutually agreed, period of time. 
5.4.2 Source Documents 

 
 
   CSD2017164 
 
24 
 
The Investigator will prepare and maintain adequate and accurate source documents (medical 
records, raw data collection forms, etc.) designed to record all observations and other pertinent 
data for each patient treated with the study drug. 
 
The Investigator will allow Sponsor representatives, contract designees, and authorized 
regulatory authority inspectors to have direct access to all documents pertaining to the study. 
 
5.5 
Adherence to Protocol 
By signing the Investigator Signature Page of this protocol, the Investigator confirms in writing 
that he/she has read, understands, and will strictly adhere to the study protocol and will conduct 
the study in accordance with ICH Harmonized Tripartite Guidelines for Good Clinical Practice 
and applicable regulatory requirements. 
 
5.6 
Adverse Events 
 
Adverse Event:  Any unfavorable or unintended sign, symptom, or disease that appears or 
worsens in a patient or clinical investigation patient during the period of observation in a clinical 
study.  The AE may be any of the following: 
 
• A new illness, 
• An exacerbation of a sign or symptom of the underlying condition under treatment or of a 
concomitant illness, 
• Unrelated to participation in the clinical study or an effect of the study product or 
comparator drug, or 
• A combination of one or more of the above factors. 
 
No causal relationship with the study product is implied by the use of the term “adverse event.”  
An exacerbation of a pre-existing condition/illness is defined as a more frequent occurrence or as 
an increase in the severity of the pre-existing condition/illness during the study.  Planned or 
elective surgical or invasive procedures for pre-existing conditions that have not worsened are 
not AEs.  However, any complication that occurs during a planned or elective surgery is an AE.  
(If the event fits the serious criteria, such as hospitalization, it will be considered a serious AE.)  
Conditions leading to unplanned surgical procedures may be AEs. 
 
When an AE occurs after written informed consent has been obtained but before the first 
exposure of study product, the AE will be considered a nontreatment-emergent AE.  Only serious 
nontreatment-emergent AEs that are related to study procedures will be collected.  An AE that 
occurs from the time the patient receives her first exposure of study product until her exit from 
the study will be considered a treatment-emergent AE.  All treatment-emergent AEs will be 
collected. 
 
Serious Adverse Event (SAE):  As provided by the ICH criteria, an SAE: 
• results in death; 
• is life threatening; 

 
 
   CSD2017164 
 
25 
 
(Note: The term “life threatening” refers to any AE that, as it occurs, puts the patient at 
immediate risk of death.  It does not refer to an AE that hypothetically might have caused 
death if it were more severe.) 
• results in hospitalization or prolongation of current hospitalization (not including 
hospitalization for a pre-existing condition that has not increased in severity or frequency 
from the patient’s underlying medical condition prior to entry into the study); 
• results in persistent or significant disability/incapacity; 
• is a congenital anomaly/birth defect in the offspring of a patient; or 
• is judged to be medically important. 
 
(Note:  A medically important AE is a medical event that may not be immediately life-
threatening or result in death or hospitalization but may jeopardize the patient or require 
intervention to prevent one of the outcomes listed above.  Medical and scientific judgment 
should be exercised in deciding whether AEs appropriately meet this criterion and are 
immediately reportable to the Sponsor.  Examples of such medical events include 
transmission of an infectious agent via a medicinal product, allergic bronchospasm that 
requires intensive treatment in an emergency room or at home and blood dyspraxias or 
convulsions that do not result in in-patient hospitalization.) 
 
SAEs must be reported to the Sponsor within 24 hours of the study center being informed of the 
AE (see Section 5.6.2). Sponsor clinical representatives are Stacey Carpenter (513-307-3221) 
and Jan Streicher-Scott (513-265-3893).  
 
5.6.1 Adverse Event Reporting 
Anticipated adverse events in this study include: mild and transient discomfort with insertion and 
removal of the Tampon. 
 
Every attempt should be made to describe the AE in terms of a diagnosis.  If a clear diagnosis 
has been made, individual signs and symptoms will not be recorded unless they represent 
atypical or extreme manifestations of the diagnosis, in which case they should be reported as 
separate events.  If a clear diagnosis cannot be established, each sign and symptom must be 
recorded individually. 
 
Any clinically significant abnormal laboratory finding, serious/unexpected AE, unanticipated 
adverse device effect, or medical event which was not present at baseline and/or which results in 
the withdrawal of a subject from the study must be followed to resolution with appropriate 
medical management unless documented as “not clinically significant” condition considered 
stable or the subject is lost to follow-up by the Investigator. Adverse events reported by subjects 
after completion or termination of study participation will not be documented in the study 
database after subject exit from the study. 
 
When completing appropriate forms for reporting the AE, the Investigator will be asked to assess 
the AE as follows: 
 
Severity of Adverse Event:  Refers to the extent to which an AE affects the subject’s daily 
activities.  Severity will be categorized according to the following criteria: 
 

 
 
   CSD2017164 
 
26 
 
-- mild - normal activities unaltered, AE is annoying, but AE is tolerable 
   -- moderate - normal activities altered or AE requires intervention 
   -- severe - unable to undertake normal activities or is incapacitated 
 
The term “severity” is used to describe the intensity of an event (as in mild, moderate, severe); 
the event itself may be of relatively minor medical significance, such as a severe headache.  This 
is not the same as “serious.”  Seriousness, not severity, serves as the guide for defining 
regulatory reporting obligations. 
 
- Investigator's Opinion of Test Product Relationship 
  -- not related - there is no medical evidence to suggest that the AE may be  
      related to investigational product usage 
  -- doubtful - there is no medical evidence to suggest that the AE may be related 
      to investigational product usage, or there is another more probable medical 
      explanation 
  -- possible - there is possible evidence to suggest that the AE could possibly be 
      related to investigational product usage 
  -- probable - there is probable evidence to suggest that the AE is probably 
      related to investigational product usage 
 
- Action Taken Regarding Test Product 
  -- none - no change in test product usage 
  -- reduced/interrupted - test product usage will be reduced or temporarily interrupted 
  -- discontinued - test product usage will be discontinued  
 
The Investigator(s) will decide on a case-by-case basis as to whether any subject should be 
dropped from the study.  If the Investigator(s) or subject decides to discontinue study 
participation, this should be documented and filed with the Sponsor within 72 hours.  All adverse 
events will be followed until resolution or until the Investigator deems it safe to discharge the 
subject.   
 
5.6.2 Serious or Unexpected Adverse Event Reporting 
 
All Serious Adverse Events will be recorded (on a Detailed Adverse Event Report) and tracked 
in this study.  A Serious Adverse Event (SAE) is “any unexpected medical occurrence that at any 
exposure:  1) Results in death; 2) Is life-threatening; 3) Requires in-patient hospitalization or 
prolongation of existing hospitalizations; 4) Results in persistent or significant 
disability/incapacity; 5) Is a congenital anomaly/birth defect, or 6) Is medically significant.  The 
Investigator will notify the Sponsor within 24 hours of any Serious Adverse Events. 
 
Medical and scientific judgment should be exercised in deciding whether 24-hour sponsor 
notification is appropriate in other situations, such as important medical events that may not be 
immediately life-threatening or result in death or hospitalization but may jeopardize the subject 
or may require intervention to prevent one of the other outcomes listed in this definition of a 
Serious Adverse Event.  These should also be considered serious. 
 

 
 
   CSD2017164 
 
27 
 
The Study Site should contact the Sponsor within 24 hours at the following numbers to answer 
questions regarding potentially serious or unexpected Adverse Events.   
  
During normal business hours or after hours:   
 
Stacey Carpenter 513-307-3221 
 
The Clinical site will be responsible for notifying the IRB of any reportable AEs in keeping with 
the site SOPs and IRB SOPs. Any notifications to the IRB also require notifications to the 
Sponsor’s reps within 24 hrs per the above.   
 
5.7 
Records Retention 
 
The Investigator(s) must retain the subject identification codes, informed consent documentation, 
and disposition of the test product, CRFs, medical records, and other source data for a minimum 
of 5 years after study completion. The Investigator(s) must receive written authorization from the 
Sponsor before destroying any study document. 
 
The Investigator(s) will make the records available for inspection and copying upon the request 
of an authorized employee of a government authority or the Sponsor, at reasonable times. 
In the event the Investigator(s) retires, relocates, or for any other reason withdraws from the 
responsibility for maintaining records for the period of time required, custody of the records may 
be transferred to another person who will accept responsibility for the records. Notice of such a 
transfer must be given in writing to the Sponsor. 
 
The sponsor will maintain clinical records according to P&G Records Management Guidelines. 
 
5.8 
Publications 
 
All data collected during this study is the sole responsibility of the Sponsor.  No publication by 
the site or any of the non-employees of the sponsor is allowed from the results of this study. The 
Sponsor reserves the right to withhold consent for publications due to the confidential nature of 
the data. Subjects will be identified only by the assigned four-digit code and no identifiable 
personal information will be included. 
 
6.0 
Study Management 
 
6.1 
Data Quality Assurance 
 
The following steps will be taken to ensure the accuracy, consistency, completeness, and 
reliability of the data: 
• Routine site monitoring, 
• Source/CRF review, and 
• Data management quality control checks 
 
In addition, a representative from the Sponsor may conduct periodic audits of study processes, 
including, but not limited to, a review of the Investigator’s Trial Master File (TMF), Standard 
 

 
 
   CSD2017164 
 
28 
 
Operating Procedures (SOPs) pertaining to the clinical study, and training records of staff 
involved. 
 
6.1.1 Monitoring 
 
Prior to the commencement of the study, an initiation meeting will be held with the appropriate 
study site personnel to review the objectives and procedures of the clinical trial.  To assure 
accurate, complete, consistent, and reliable data, the study site(s) and study procedures will be 
monitored by a representative of the Sponsor according to the US CFR Title 21 Part 312 and 
ICH Guideline for GCP (Section 5.18).  The investigator will permit Sponsor’s representative(s) 
to make consistent site visits during the study.  The frequency of monitoring visits will be agreed 
upon as to the most appropriate intervals as determined by the Sponsor and the study site. 
6.2 
Study Termination 
 
The study may be terminated at any time at the request of the Sponsor or a regulatory authority.  
In addition, individual study centers may be suspended or withdrawn by the Sponsor or may 
choose to withdraw from participation in the study.  In such cases, all parties will be notified in a 
proper and timely fashion.  The IRB will be informed promptly and the Sponsor or the 
Investigator will supply reason(s) for the termination or suspension, as specified by the 
applicable regulatory requirements.  Otherwise, the study is considered terminated upon 
completion of all patient treatments and evaluations. 
 
6.3 
Investigator(s) Final Report 
 
The Investigator or designee will submit a study report to the Sponsor within 4 weeks following 
study completion or termination.  This report should include:  
 
• Investigator’s designee of authority statement for specific tasks, e.g., designation 
by investigator to a qualified staff person to enroll subjects. 
• Personnel list of responsibilities (including any non-Test Site Facility personnel) 
• Number of subjects screened for eligibility 
• Number of subjects entering and completing the study 
• Number of subjects that withdrew from the study and reasons for withdrawal 
• Any deviations or changes/amendments to the protocol 
• Summary of adverse events 
• Clinical judgments relative to any significant adverse events and their 
disposition; any alterations in treatment due to adverse events 
• Records of the study site visits by the Sponsor 
• Notes to file 
• Data transfer 
• Forms disposition 
• Signed and dated quality assurance statement ensuring protocol compliance 
 
 
 
 

 
 
   CSD2017164 
 
29 
 
 
Appendix    1 
Schedule of Study Procedures 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
STUDY 
ACTIVITIES 
 
SCREENING, 
VISIT 1 
 (~ 2 WEEKS 
BEFORE 
START OF 
MENSES) 
LAB 
RESULTS 
REVIEW 
FOR QUAL 
(NOT A  
VISIT) 
VISIT 2, 
AT LEAST 
1 DAY 
PRIOR TO 
START OF 
MENSES 
 
VISIT 3 
WITHIN 
72 HRS 
AFTER 
LAST 
TAMPON 
USE 
VISIT 4 
WITHIN 
72 HRS  
AFTER 
LAST 
TAMPON 
USE  
VISIT 5 
WITHIN 
72 HRS 
AFTER 
LAST 
TAMPON 
USE  
VISIT 6 
WITHIN 72 
HRS AFTER 
LAST 
TAMPON 
USE –FINAL 
EXAM 
INFORMED CONSENT 
X 
 
 
 
 
 
 
INCL./EXCL./DEMOGRAPHICS 
X 
 
 
 
 
 
 
VAGINAL DISCHARGE, VAGINAL 
EXAM, STI VAGINAL SWABS & 
VAGINAL PH, PREG TEST 
X 
 
 
 
 
 
 
VAGINAL MICROBIOME SWABS  
X 
 
 
X 
X 
X 
X 
STI SCREEN LAB (BV, 
CANDIDA,TRIC, GONO, 
CHLAMYDIA,) RESULTS REVIEW 
FOR EXCLUSIONARY CRITIERA 
 
X 
 
 
 
 
 
CONTINUANCE CRITERIA  
 
 
X 
X 
X 
X 
X 
CONCOMITANT MEDICATIONS 
(CON_MED) 
 
 
X 
X 
X 
X 
X 
GYN HISTORY QUESTIONNAIRE 
X 
 
 
 
 
 
 
VAGINAL EXAM + VAGINAL PH 
& VAGINAL DISCHARGE 
ASSESSMENT 
 
 
 
X 
X 
X 
X 
DISTRIBUTE TEST PRODUCTS 
ACCORDING TO RANDOMIZATION, 
INCLUDING BACK UP PANTY 
LINER/PAD PROTECTION IF 
DESIRED 
 
 
X 
Distrib  
Unit 1  
X 
Collect 
Unit 1, 
Distrib  
Unit 2 
X 
Collect 
Unit 2, 
Distrib  
   Unit 3 
X 
Collect 
Unit 3, 
Distrib  
Unit 4 
X 
Collect  
Unit 4 
DISTRIBUTE/COLLECT MONTHLY 
COMFORT AND PRODUCT USE 
QUESTIONNAIRE AND REVIEW FOR 
PROPER COMPLETION 
 
 
X 
Distrib 
 Unit 1 
 
 
X 
Collect 
Unit 1, 
Distrib  
Unit 2 
X 
Collect 
Unit 2, 
Distrib  
Unit 3 
X 
Collect 
Unit 3, 
Distrib  
Unit 4 
X 
Collect  
Unit 4 

 
 
   CSD2017164 
 
30 
 
 
Appendix   2 
 
Risk Assessment 
 
This study is a four month in use randomized, cross over, controlled, double blind study to assess 
the tolerability and comfort of four tampon products.  The study will be conducted at Radiant 
Research (Cincinnati, OH) under the direction of Michael Noss, MD.  The study will include up 
to 100 women ages 18-55 years who currently use tampons as their primary source for menstrual 
protection and hygiene. 
  
The test products and test methods along with the study design described in this protocol for 
CSD2017164 are assessed as minimal risk based on the probability and magnitude of harm or 
discomfort anticipated in the study not being greater than those ordinarily encountered in daily 
life or during the performance of routine physical or psychological examinations or tests.  This 
assessment is based on study design, appropriate inclusion/exclusion criteria for eligibility, 
physician oversight, properly trained study personnel, safe history of use of these tampons and/or 
similar tampon products, proper usage instructions and controlled product use.   
 
The study procedures will include non-invasive measurements of the labia minora, vagina and 
introitus as detailed above.  During study conduct, subjects will be asked to participate in the 
following procedures at various time points: speculum insertion, vaginal assessment, and/or 
vaginal sampling. Assessment may include non-invasive measurements for vaginal discharge, 
pH, visual grading for erythema, abrasions, ulcerations, and superficial tissue/cell collection. The 
study site staff will have sufficient training and experience with each of these minimal risk 
procedures. The side effects associated with this examination and technical measures are 
expected to be minimal.  
 
 
 
 
 
 
Karen Acuff, Ph.D. 
 
 
 
 
 
Date 
Safety 
 
 
 
 
 
 
Kathleen Blieszner, Ph.D. 
 
 
 
 
Date 
         Regulatory  
 
 
 

 
 
   CSD2017164 
 
31 
 
Appendix 3 
Gynecological History (sample) 
 
 
 
 
1. 
Number of vaginal births. 
 
 
 
 
 
 
 
 
 
 
2. 
Number of cesarean births. 
 
 
 
 
 
 
 
 
 
 
3. 
Are you currently breastfeeding? 
 
Yes 
 
No 
 
 
 
 
 
 
4. 
What is the average duration of your period/discharge? (i.e. 5 days) 
 
 
 
Days 
 
 
 
 
 
 
5. 
What is the heaviest flow day (after start of flow) during your 
 
Day 
 
 
 
period? (Example: Day 2) 
 
 
 
 
 
 
 
 
 
 
6. 
What is the average time between the end of your period and the  
 
 
 
Days 
 
start of your next period? 
 
 
 
 
 
 
 
 
 
 
7. 
How old were you when you first started to menstruate? 
 
 
 
Years 
 
 
 
 
 
 
8. 
How old were you when you first started to use tampons? 
 
 
 
Years 
 
 
 
 
 
 
9. 
Have you ever had pelvic or perineal surgery? 
 
Yes* 
 
No 
 
(e.g. episiotomies, etc.) 
 
 
 
 
 
 
 
 
 
 
 
*If yes, describe surgery: 
 
 
 
 
 
_______________________________________________________ 
 
 
 
 
 
_______________________________________________________ 
 
 
 
 
 
 

 
 
   CSD2017164 
 
32 
 
10. 
Are you currently using a birth control method? 
 
Yes 
 
No 
 
If yes, please answer question #11. If no, do not answer question #11. 
 
 
11. 
If currently using a birth control method, check type and list length of time used: 
 
 
Contraceptive 
Methods 
 
Using? 
    (check all applicable) 
 
Length of Time Used 
(ex.   04 yrs., 03 mths) 
 
 
 
 
        years 
           months 
Oral Contraceptive  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Norplant  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Contraceptive Injection 
 
 
 
 
 
 
 
 
(i.e.  Lunelle, Depo Provera) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hormonal Ring (i.e. NuVa) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Contraceptive Patch 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Spermicide  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Condoms  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IUD  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Tubal Sterilization 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vasectomy (partner) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Other:  Describe______________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
12. 
In the past 12 months, have you had a genital infection? 
 
Yes 
 
No 
 
(If yes, complete the table below) 
 
 
 
 
 
 
 

 
 
   CSD2017164 
 
33 
 
 
Type of infection 
(check all that apply) 
Number of 
infections 
in last 12 
months 
Date of most 
recent 
infection 
of this type 
How was the infection treated 
Yeast 
 
 
 
 
Genital Herpes 
 
 
 
 
Gonorrhea 
 
 
 
 
Trichomonas 
 
 
 
 
(Human Papilloma Virus) HPV   
 
 
 
Genital Warts 
 
 
 
 
Cytomegalovirus 
 
 
 
 
Chlamydia 
 
 
 
 
Other (________) 
 
 
 
 
 
 
 
13. 
Do you have any known allergies? 
 
Yes* 
 
No 
 
*If yes, list the allergies: 
 
 
 
 
 
______________________________________________________ 
 
 
 
 
 
______________________________________________________ 
 
 
 
 
 
______________________________________________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
14. 
Are you currently taking any medications to treat your allergies? 
 
Yes* 
 
No 
 
*If yes, record medications on medication log 
 
 
 
 
 
 
 

 
 
   CSD2017164 
 
34 
 
Appendix   4 
Vaginal Health General Procedures  
In General 
A physician will conduct all vaginal exams on all subjects at the time points indicated in the Study Events 
table of the protocol.   
 
At the Screening visit, Vaginal swabs will be collected to rule out positive results Trichomonas, BV and 
Yeast, Chlamydia, and Gonorrhea (STI).   
 
Supplies: 
• 
Plastic, clear speculums should be used 
• 
Sterile saline 
• 
Appropriate lighting such as a gooseneck lamp or a headlamp; same lighting should be used at all 
examination intervals 
• 
Aptima Swabs 
 
Vaginal Assessments, Documentation of Findings, and Follow Up PRN 
The study Physician of record will conduct the procedures and vaginal exam/assessments appearing 
below.  Any potential confounding activities will also be assessed during the vaginal exam i.e., sexual 
activity within the past 48 hours or intra-vaginal product use other than study supplied tampons.   
 
All findings either normal and abnormal, will be documented in the eCRF Form, noting score (for 
erythema) and absence or presence of abrasion, ulceration, laceration, and color and character of vaginal 
discharge and any evidence of sexually transmitted disease.  Document the location, extent, and detailed 
description of any findings in comments.   
 
Study subjects who have abnormalities or irritation noted on their gynecological examination form may 
be scheduled for a follow up examination.  The Study Physician will determine whether follow-up is 
necessary.  Follow up examinations will occur 1-2 weeks before the start of the subject’s next menstrual 
period. 
 
Procedure Order:  
• 
Subjects will be placed in the dorsal lithotomy position.   
• 
Observe external genitalia and record any findings on eCRF Form;  
• 
A speculum will be inserted into the vagina to visualize the upper 1/3 of the vagina; 
• 
Using the scales and descriptors outlined in the protocol and Appendices, record all findings on 
eCRF Form; 
 
 

 
 
   CSD2017164 
 
35 
 
Appendix   5 
 
ERYTHEMA GRADING SCALE 
 
 
0 
No apparent cutaneous involvement. 
 
0.5 
Greater than 0, less than 1. 
 
1 
Faint but definite erythema, no eruptions or broken skin or no erythema but definite   
             dryness; may have epidermal fissuring. 
 
1.5 
Greater than 1, less than 2. 
 
2 
Moderate erythema, may have a few papules or deep fissures, moderate-to-severe  
              erythema in the cracks.   
 
2.5 
Greater than 2, less than 3. 
 
3 
Severe erythema (beet redness), may have generalized papules or moderate-to-severe  
             erythema with slight edema. 
 
3.5 
Greater than 3, less than 4. 
 
4 
Generalized vesicles or eschar formations or moderate-to-severe erythema and/or  
             edema. 
 
NOTE: 
The degree of reaction expressed by such descriptive terms as "moderate" and "severe" is, in  
                    itself, subjective.  Such terminology can be accurately understood only through experience. 
 
Any reaction of greater severity than Grade 4 should be described in detail.  Unusual reactions not 
described by the scale should also be described. 
 
 
TYPICAL EXAMPLES OF HALF-GRADE SCORES 
 
0.5 
Faint, barely perceptible erythema or slight dryness (glazed appearance). 
 
1.5 
Well-defined erythema or faint erythema with definite dryness, may have epidermal fissuring. 
 
2.5        Moderate erythema with barely perceptible edema or severe erythema, may have a few papules or 
moderate-to-severe erythema. 
 
3.5 
 Moderate-to-severe erythema with moderate edema or moderate-to-severe erythema with isolated 
eschar formations or vesicles. 
 
 
 
 

 
 
   CSD2017164 
 
36 
 
Appendix   6 
Vaginal Examination (sample)  
 
 
Ulceration/Abrasion These lesions will be noted as either No (absent) or Yes (present) only. 
 
 
Erythema1 
 
Abrasion2 
 
Ulceration3 
 
 
 
 
 
 
Yes 
No 
 
Yes 
No 
Labia Minora: 
 
· 
 
 
 
 
 
 
 
Introitus: 
 
· 
 
 
 
 
 
 
 
Lower Vaginal Walls: 
 
· 
 
 
 
 
 
 
 
Middle Vaginal Walls: 
 
· 
 
 
 
 
 
 
 
Upper Vagina (incl. Fornices): 
 
· 
 
 
 
 
 
 
 
Cervix: 
 
· 
 
 
 
 
 
 
 
 
 
Prolapse Present: 
Bladder [ ] Yes   [ ] No    Uterine [ ] Yes   [ ] No   Rectal [ ] Yes   [ ] No 
 
Based on this Examination: 
Is a follow-up visit indicated? 
Yes* 
 
No  
*If yes, state reason: ________________________________ 
 
 
  
 
 
 
  
Does the subject meet (continue to meet) study eligibility? 
Yes 
 
No*  
*If no, state reason: ________________________________ 
 
 
  
 
 
                                                          
1 Erythema Scale.  Record scores as:  0.0, 0.5, 1.0, 1.5, etc. 
2 Abrasion – ‘yes’ indicates partially disrupted epithelium, blood vessels may be intact or disrupted.  
Diffuse area of demarcation. 
3 Ulceration – ‘yes’ indicates tear in or sloughing of epithelium, blood vessels may be intact or disrupted.  
Sharp demarcation. 
 
 
 
 
 

 
 
   CSD2017164 
 
37 
 
Appendix   7 
Vaginal Assessment 
 
Vaginal pH  
 
 
1) Use appropriate personal protective equipment. 
2) Vaginal pH is measured before the insertion of a speculum. 
3) A pH test strip (2.0-9.0 range) is grasped at the end and either held by hand or a sterile 
hemostat (long tool capable of reaching into the vagina thru the speculum) and carefully 
brought to the vagina. 
4) The strip is moistened with the "fluid" from the middle to upper third of the lateral wall 
of the vagina.  It is held in place for 30 sec. 
5) The strip is carefully removed and the colour change should be "read" immediately after 
removal. 
6) The corresponding pH value is recorded on the eCRF Database 
 
 
 
Materials 
BDH Cat No. 83930.601; gradation in 0.5 units between 2.0 and 9.0. 
 
____________________________________________________________________________________ 
 
 
VAGINAL DISCHARGE: 
 
Discharge: 
 Normal 
 Abnormal 
 
 
If Abnormal, please indicate color and consistency below: 
 
 
Color  
 
 
Consistency 
 White 
 Red  
 Flocculent 
 
 
 Gray 
 Green 
 Frothy  
 Yellow 
 Brown 
 Cheesy 
 Other 
 
 
 Other 
 
If Other, please describe: 
 
______________________________________________________ 
 
Evidence of sexually transmitted diseases or other infections? 
Yes 
No 
If yes, describe: 
 
 
 
 
 

 
 
   CSD2017164 
 
38 
 
Appendix   8 
STI Microbiology Screening (Visit 1 Only) 
 
Vaginal swab samples will be collected at the screening visit (Visit 1).  In keeping with GCP’s, 
subject’s specimens will be identified only by their 4-digit subject number.   
Aptima swabs will be used for wet mount samples.   
All subjects will be screened for the microflora exclusion criteria BV (bacterial vaginosis), 
Candida spp., Trichomonas vaginalis, Chlamydia trachomatis, and Neisseria gonorrhoeae.  The 
presence of three of the four following criteria is diagnostic of BV: (1) non-viscous homogenous 
milky Vaginal Discharge, (2) vaginal pH > 4.5, (3) the presence of a fishy amine odor or the 
production of the odor upon the addition of potassium hydroxide (KOH) to the vaginal 
discharge, and (4), the presence of clue cells (> 20 % clue cells). All subjects will be tested for 
Candida spp., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae using 
suitable diagnostic methods.  Subjects testing positive for any of the microbial vaginal exclusion 
criteria will be dismissed from further study participation.   
Tests for Bacterial Vaginosis, Candida spp., Trichomonas vaginalis:  Vaginal samples are 
treated as follows.  Gently agitate the vaginal swab suspension and place one drop on a glass 
slide.  Apply a cover slip and examine under low- and high-power magnifications, looking for 
clue cells (vaginal epithelial cells with indistinct cell borders obscured by large numbers of 
attached microorganisms).  The presence of clue cells (> 20 % clue cells) is consistent with the 
diagnosis of nonspecific vaginosis (BV); pseudohyphae is consistent with Candida spp.; and 
motile trichomonads is consistent with Trichomonas vaginalis. Add a drop of 10% KOH for 
detection of yeast pseudohyphae and presence of a fishy amine odor. 
Tests for Chlamydia trachomatis and Neisseria gonorrhoeae:  A nucleic acid probe-based 
method is recommended, e.g. the PACE 2 System (Gen-Probe, Inc., San Diego, CA).  
Endocervical samples will be handled per manufacturer’s instructions.   
 
 
Results for all microbiological screening will be captured in the eCRF Database. 
 
 
 
 

 
 
   CSD2017164 
 
39 
 
Appendix 9 
Vaginal Swab for Microbiome Assessment  
 
Microbiome swab sample will be collected at Visit 1 (Screening), 3, 4, 5 and 6.  In keeping with GCP’s, 
subject’s specimens will be identified only by their 4-digit subject number.   
 
Materials Needed for the Sampling: 
1. COPAN ESwab™ (COPAN Diagnostics Inc.)  
A Sterile Peel Pouch Package with: 
• 
A Nylon Flocked Swab 
• 
A Screw Cap Tube with 1 ml of liquid Amies  
2. Sterile Saline 
Prior to sampling: 
 
1. Note whether subject has used antibiotics within 1 week prior to this sampling procedure on their 
case report form.  Subjects will need to undress below the waist and be provided appropriate 
covering while waiting for the procedure.   
2. Subjects will be positioned appropriately for sampling (i.e.; feet in stirrups of gynaecologic exam 
table).       
3. This vaginal swabbing procedure will be conducted following the visual vaginal exam and prior 
to subsequent vaginal swabbing for vaginal infections or sexually transmitted diseases. 
 
During Sampling (Aseptic technique must be followed with regard to swab handling; minimize open 
tubes, use sterile solutions etc.) 
 
1. Use appropriate hand hygiene and apply gloves.  
2. Open the peel pouch and remove the swab from the pouch with care (must not touch the area 
below the marked breakpoint indication line and avoid touching the swab tips to any unintended 
surface to avoid contamination).  
3. Pre-moisten the swab by dipping it into the sterile saline tube for 5 seconds. 
4. Insert speculum by wetting with saline or lubricant (if not already done). 
5. When swabbing: insert the moist swab beyond the tip of the speculum, in the posterior fornix, 
being careful not to touch the tip of swab to any unintended surface to avoid contamination. Note, 
the sample should be obtained from an area of the posterior fornix that has not been in contact 
with the speculum. 
6. Rotate the swab 5 times (clockwise 2 times and counter clockwise 3 times), pressing lightly against 
the vaginal wall.  
7. Carefully remove the swab without touching any unintended surface. 
8. Remove the ESwab tube from the pouch and uncap. 
9. Insert the swab all the way to the bottom of the tube. 
10. Holding the swab shaft close to the rim of the tube, break the swab shaft at the colored breakpoint 
line while holding the tube opening away from your face. 
11. Screw the cap on tightly to prevent leakage. 
12. Apply a label to the tube and then store the samples at -20C until shipping.    
13. Visually assess the fornix region after all swabs are collected and note any new visual findings.  
14. The samples will be shipped on dry ice to MBC micro lab to the below address: 
Yuli Song, DS3-6F5 
                     
P&G Mason Business Center  
8700 Mason Montgomery Road  
Mason, OH 45040 
 

 
 
   CSD2017164 
 
40 
 
Appendix   10 
 
 
 
SUBJECTS INSTRUCTIONS 
SITE TO PROVIDE 
 
 
 

 
 
   CSD2017164 
 
41 
 
Appendix   11 
 
INFORMED CONSENT  
Site to Provide 
 
 

 
 
   CSD2017164 
 
42 
 
Appendix 12 
     Subject Number 
 
  Subject Initials 
 
 
TAMPON USE DIARY  2017164 
 
 
 
 
 
 
 
 
 
 
First Day of Menstrual Cycle:   Date ______ /______ /________ Last Day of Menstrual Cycle:  Date ______ / ______ / _______                 VISIT:  ______________ 
Instructions: Fill in table below for each tampon use:   place an X in column for ‘YES’, leave column blank for ‘NO’ 
 
 
 
 
 
TAMPON 
DATE     
Tampon 
Inserted 
 
Time  
of Insertion 
 
DATE 
of Removal 
 
Time of Removal 
 
Insertion 
Discomfort 
 
Wearing 
Discomfort 
 
Removal 
Discomfort 
 
Sensation During Use? 
How would you rate 
this tampon’s overall 
comfort?  
# 
Code 
Itching 
Burning 
Stinging 
1 
2 
3 
4 
5 
Ex. 
D 
10-1-17 
10:10 am 
10-1-17 
12:30 am 
 
 
X 
 
 
 
 
 
X 
 
 
1 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
2 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
3 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
4 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
5 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
6 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
7 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
8 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
19 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
10 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
11 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
12 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
13 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
14 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
15 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
How would you rate 
this tampon’s 
overall comfort?   
Place ‘X’ in 
appropriate column 
above 
Very 
Comfortable 
Comfortable 
Neither 
Comfortable nor 
U
f
bl
Uncomfortable 
Very 
Uncomfortable 
1 
2 
3 
 
4 
5 
Subject Signature 
 
 
 
 
Date 
Product Code: ______ 

 
 
   CSD2017164 
 
43 
 
Subject Number 
 
  Subject Initials 
 
 
TAMPON USE DIARY  2017164 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
First Day of Menstrual Cycle:   Date ______ /______ /________ Last Day of Menstrual Cycle:  Date ______ / ______ / _______                 VISIT:  ______________ 
Instructions: Fill in table below for each tampon use:   place an X in column for ‘YES’, leave column blank for ‘NO’ 
 
 
 
 
 
TAMPON 
DATE     
Tampon 
Inserted 
 
Time  
of Insertion 
 
DATE 
of Removal 
 
Time of Removal 
 
Insertion 
Discomfort 
 
Wearing 
Discomfort 
 
Removal 
Discomfort 
 
Sensation During Use? 
How would you rate 
this tampon’s overall 
comfort?  
# 
Code 
Itching 
Burning 
Stinging 
1 
2 
3 
4 
5 
Ex. 
DS 
10-1-17 
10:10 am 
10-1-17 
12:30 am 
 
 
X 
 
 
 
 
 
X 
 
 
16 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
17 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
18 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
19 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
20 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
21 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
22 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
23 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
24 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
25 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
26 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
27 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
28 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
29 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
30 
 
 
          : 
 
          : 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
How would you rate 
this tampon’s 
overall comfort?   
Place ‘X’ in 
appropriate column 
above 
Very 
Comfortable 
Comfortable 
Neither 
Comfortable nor 
f
Uncomfortable 
Very 
Uncomfortable 
1 
2 
3 
 
4 
5 
ubject Signature 
 
 
 
 
Date 
Product Code: ______ 

 
 
   CSD2017164 
 
44 
 
Appendix 13 
 
 
 
 
 
 
 
 
 
 
 
 
     Subject Identification Number                       Subject Initials                           (mm)             (dd)              (yyyy) 
 
Product Code ___________ 
POST-USE QUESTIONNAIRE 
 
Please, completely fill in ovals: ⚫ 
 
             Do not mark ovals:             √ 
 
Thank you for taking a few minutes of your time to complete this survey. The reason we are 
conducting this research is to understand your opinions and your experience while on this study. 
Therefore, it is very important that you answer each question candidly and thoughtfully 
 
 
 
 
1. Considering everything about your experience with the tampon you used, please indicate 
the one word or phrase which best describes your overall satisfaction with your experience 
with the tampon: 
o Very satisfied 
o Somewhat satisfied 
o Neutral 
o Somewhat dissatisfied 
o Very dissatisfied 
 
 
2.    Please RATE the tampon over the use period for each of the following characteristics. 
(Select one answer for each row) 
Excellent 
Very Good 
Good 
Fair 
Poor 
Overall comfort 
o 
o 
o 
o 
o 
Overall protection 
o 
o 
o 
o 
o 
Overall quality  
o 
o 
o 
o 
o 
Providing me with protection I trust 
o 
o 
o 
o 
o 
Providing me with comfort I trust 
o 
o 
o 
o 
o 
Being so comfortable I can’t feel it 
o 
o 
o 
o 
o