An Open-Label Clinical Validation Study of an Applicator Tampon
Phase: NA
Conditions: Menstruation
Sponsor: Kimberly-Clark Corporation

 
 
Clinical Study Protocol  
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1 TITLE PAGE 
 
Clinical Study Protocol 
 
 
 
 
Protocol Title:
An Open-Label Clinical Validation Study of an Applicator Tampon
Protocol #:
AFC-21-001
Sponsor: 
 
Kimberly-Clark Corporation
Protocol Date:
24 August 2022
 
Version:
2.0
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NCT05553600

 
 
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SPONSOR PROTOCOL APPROVAL SIGNATURE PAGE 
 
Protocol #: 
AFC-21-001 
Title: 
 
An Open-Label Clinical Validation Study of an Applicator Tampon 
Date:  
24 August 2022 
Version: 
2.0 
 
Reviewed and approved by the following Sponsor Representative:  
Director, Global Medical Affairs 
 
 
 ________________  
Signature  
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Aug 26, 2022

 
 
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INVESTIGATOR STATEMENT 
 
An Open-Label Clinical Validation Study of an Applicator Tampon 
I, the undersigned, have read this protocol and agree to conduct this protocol in accordance with ethical 
principles as outlined in the International Council for Harmonisation (ICH) guidelines on Good Clinical 
Practice (GCP), any applicable laws and requirements and any additional conditions mandated by a 
regulatory authority and/or Institutional Review Board/Independent Ethics Committee (IRB/IEC). 
I acknowledge that I am responsible for the overall study conduct and I agree to personally conduct or 
supervise the described clinical study. 
I agree to ensure that the confidential information contained in this document will not be used for any 
purpose other than the evaluation or conduct of the clinical investigation without the prior written 
consent of Kimberly-Clark Corporation. 
 
 
 
 
_____________________________  
_____________________________ 
 ________________  
Principal Investigator Printed Name  
PI Signature  
 
 
 
Date 
 
 
 
 
 
 
 
 
 

 
 
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2 PROTOCOL SYNOPSIS 
 
Protocol Title:
An Open-Label Clinical Validation Study of an Applicator Tampon
Protocol #:
AFC-21-001
Study Design:
This prospective multi-center, open-label, randomized, cross-over 
study is designed to validate that changes to the design of
tampons meet the following user needs: - 
product to remain clean prior to use, product to remain in working 
condition prior to use, to be able to  access the product, to be able to 
vaginally insert and place the tampon, to be able to remove product 
from the vagina after use, product to absorb fluid, to be able to 
distinguish between absorbency levels, packaging to be labeled 
properly.   
Subjects will be assigned to one of two arms in the study: a regular 
absorbency arm or a super absorbency arm.  Within each arm, a 
subset of 60 subjects will undergo gynecological exams prior to and 
following tampon use.   
Subjects will be randomly assigned the order in which to test a new 
tampon design (test tampon) and a currently marketed tampon 
(reference tampon).  Each tampon type will be used over the course 
of one (1) menstrual cycle.  Subjects will be provided with 16 
tampons per menstrual cycle.   
For subjects undergoing gynecological exams, the study consists of 4 
visits for each study subject, 2 visits for each menstrual cycle: one 
before and after each menstrual cycle.  The first visit will be both the 
screening and the first pre-use visit.  Pre-use visits will be conducted 
within 72 hours prior to expected menstruation.  Post-use visits are 
to be completed within 72 hours following the last tampon use for 
that menstrual cycle.  Subjects will undergo gynecological exams at 
each visit.  Subjects will keep a daily diary during menstruation with 
entries for every tampon use.  Subjects will also collect each used 
tampon to be returned to the clinical site for inspection by study staff 
to assess tampon integrity.  Additionally, these subjects will complete 
an interview during the first visit to assess whether the subject can 
locate key information on the product packaging.   
For the remainder of the subjects, the study will consist of 3 visits for: 
a screening and pre-use visit, and two post-use visits.  Post-use visits 
are to be completed within 72 hours following the last tampon use 
for that menstrual cycle.  Subjects will keep a daily diary during 
menstruation with entries for every tampon use.  Subjects will also 
collect each used tampon to be returned to the clinical site for 
inspection by study staff to assess tampon integrity. 
 

 
 
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Objective:
The objective of this study is to validate that changes in the design of 
the
tampons meet defined user needs.   
Endpoints:
 Primary: 
 
 
 
 
 
Key Secondary: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
The proportion of used tampons that have elongated will be used to 
assess the following user need: 
 
User can remove product from the vagina after use 
Analysis will be done separately for each absorbency. 
Diary responses will be used to assess the following user needs: 
 
Product to remain clean prior to use  
 
Product to remain in working condition prior to use 
 
User can access the product  
 
User can vaginally insert and place the tampon 
 
User can remove product from the vagina after use 
 
Product absorbs fluid 
Analysis will be done separately for each absorbency.   
Interview responses will be used to assess the following user needs: 
 
User is able to distinguish between absorbency levels 
 
Packaging is labeled properly 
Interview responses will be analyzed for both absorbencies 
combined. 
Product tolerability will be evaluated through the following 
measures: 
 
Gynecological exam findings 
 
Frequency and severity of adverse events  
 
Validation Criteria:
The objective will have been met if the following criteria are met:
 
The test tampon elongation rate is the same as or better than 
the reference tampon for each absorbency, where same is 
defined as test tampon elongation rate ≤ reference tampon 
elongation rate. 
 
Product tolerability is deemed to be acceptable based on 
review of the results. 
 
Diary responses have ≥ 96% response rates consistent with 
each user need for each absorbency.  If the rate is lower than 
96%, the response rate consistent with the user need related 
to the test tampon must be the same as or better than the 
response rate of the reference tampon, where same is 
defined as test tampon response rate ≥ reference tampon 
response rate.   
 
Interview responses demonstrate that 95% of users are able 
to identify key information on the package and insert, and 

 
 
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able to distinguish between absorbency levels on the 
wrappers. 
Population:
The study population consists of 2 arms of approximately 369 females
(total 738 subjects), ages 18-49, in good general health, in the United 
States who normally use tampons for menstrual protection, 
menstruate regularly, and do not have a history of Toxic Shock 
Syndrome (TSS).  One arm will test regular absorbency tampons and 
the other will test super absorbency tampons. Within each of these 
arms, a subset of 60 subjects will undergo gynecological exams 
before and after product use.  
Eligibility Criteria: 
Inclusion Criteria
1. 
Willing and able to read and provide written informed 
consent. 
2. 
Female in good general health, age 18-49 (inclusive). 
3. 
Last pap smear was normal in the past 3 years, or a normal 
pap with a negative HPV in the past 5 years, or negative HPV 
in the last five years (age <21 does NOT need a PAP or HPV 
result) based on self-report 
4. 
History of regular menstrual cycles during the previous 3 
months lasting approximately 21-35 days, including at least 4 
days of menstruation, and expecting to menstruate during 
the study period. 
5. 
Tracks menstruation and able to confidently predict onset of 
menstruation within 72 hours. 
6. 
History of use of applicator tampons without discomfort. 
7. 
Normally use at least 6 tampons for protection during 
menstruation. 
8. 
Normally uses regular, super, and/or super plus absorbency 
tampons for menstrual protection. 
9. 
If uses super plus absorbency, must be willing to wear 
nothing greater than super absorbency for the duration of the 
study. 
10. Agrees not to use douching substances, vaginal medications, 
suppositories, or vaginal devices for the duration of the study.
11. [For subjects undergoing gynecological exams only] Agrees 
not to apply feminine deodorant spray, powders, perfumes, 
wipes, lotions, creams, or emollients to the genital area for at 
least 24 hours prior to each visit. 
12. Agrees not to try any new products in the vaginal/perineal 
area two (2) weeks prior to the study start and for the 
duration of the study. 
13. Agrees to the conduct of all study procedures, including 
gynecological exams (if applicable), and agrees to follow all 
study instructions and return for scheduled appointments. 
14. Has used an acceptable form of birth control for at least one 
month prior to enrollment and for the duration of the study. 
Acceptable methods include hormonal contraceptive, IUD, 

 
 
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tubal ligation, partner vasectomy, condom (with or without 
spermicide), or abstinence.  
Exclusion Criteria 
1. Pregnant, lactating or is trying to become pregnant. 
2. Less than six (6) weeks post-partum. 
3. Has a menstrual abnormality (such as oligomenorrhea or 
amenorrhea). 
4. History of any of the following diagnoses based on self-
report: diabetes, active genital herpes lesion in last 3 years, 
Human Immunodeficiency Virus (HIV), Pelvic Inflammatory 
Disease (PID), Toxic Shock Syndrome (TSS). 
5. History of an abnormal pap smear within the last 3 years, 
positive HPV in the last 5 years, any form of gynecological 
cancer, or gynecological disorder such as fibroids, or 
endometriosis (by self-report).  Participants that have had a 
history of an abnormal pap smear, but most recent pap 
smear has been normal, may be included. 
6. Has a medical condition which might compromise her 
immune system functions (such as cancer, 
immunosuppressive therapy, anemia currently being treated 
under the care of a physician, leucopenia, HIV-positive, or 
organ transplant). 
7. Has used steroid medications (systemic or topical) for 
fourteen (14) or more consecutive days within the last sixty 
(60) days. 
8. [For subjects undergoing gynecological exams only] Has 
Type B (petechia, ecchymoses) or C (peeling, abrasions, 
ulcerations, or lacerations) lesions on the perineum, vulva, 
urethra, vagina, or cervix as determined by the investigator at 
the screening visit.  
9. [For subjects undergoing gynecological exams only] Has 
Type A (erythema or edema) lesions covering >50% of any of 
the perineum, vulva, urethra, vagina, or cervical locations as 
determined by the investigator at the screening visit. 
10. Has had clinically identified genital warts/lesions and/or 
urogenital infection (such as bacterial vaginosis, 
Trichomoniasis, yeast infection, Chlamydia trachomatis, 
Neisseria gonorrhea, or a urinary tract infection) within the 
past 6 weeks.  
11. Has a known allergy or sensitivity to components of the 
investigational products, including rayon. 
12. Any other medical condition or history, as determined by the 
Investigator that could compromise the study results or 
subject safety. 
 
Planned Number of Sites:
Up to 9 sites in the United States

 
 
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Test Article(s):
 
Modified
Tampons – Regular and 
Super Absorbencies (test tampons) 
 
Commercial
Tampons – Regular 
and Super Absorbencies (reference tampons) 
Anticipated Study Duration:
Approximately 6 months
Participant Duration:
Approximately 2 months
 
 
 
 
 
 
 
 
 
 

 
 
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Table 1 - Proposed Schedule of Events 
 
Event 
Visit 1 
Screening/Baseline 
Visit 2 
Post-Use Visit 
Visit 3 
Pre-Use Visit 
Visit 4 
Post-Use Visit 
Unscheduled 
Visit 
Informed Consent 
X 
 
 
 
 
Inclusion/Exclusion 
X 
 
 
 
 
Demographics 
X 
 
 
 
 
Medical History 
X 
 
 
 
 
Concomitant Medications 
X 
X 
X 
X 
X 
Gynecological Symptom Assessment 
X 
X 
X 
X 
X 
Gynecological Exam  
(visual inspection, infection assessment, vaginal 
discharge, and vaginal pH) 
X 
X 
X 
X 
X 
Packaging/Labeling Interview  
X 
 
 
 
 
Randomization 
X 
 
 
 
 
Test Article and Diary Dispensation 
X 
X* 
X* 
 
 
Diary Training 
X 
X* 
X* 
 
 
Test Article Collection  
(used and unused products) 
 
X 
 
X 
 
Diary Review 
 
X 
 
X 
 
Tampon Integrity Assessment 
 
X 
 
X 
 
Adverse Event Collection
 
X 
X 
X 
X 
Study Completion 
 
 
 
X 
 
*As needed 
Key: 
 
X 
Conducted for all subjects 
X 
Conducted for a subset of 120 subjects (Note, Visit 3 is only required for this subset of subjects) 

 
 
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3 TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF FIGURES 
1 
Title Page .......................................................................................................................................... 1 
sponsor Protocol Approval Signature Page ............................................................................................. 2 
Investigator Statement ................................................................................................................................ 3 
2 
Protocol Synopsis ............................................................................................................................ 4 
3 
Table of Contents, List of Tables, and List of Figures ............................................................... 10 
4 
List of Abbreviations and definitions of terms ........................................................................... 11 
Introduction ................................................................................................................................................ 12 
5 
Trial Objectives and Purpose ....................................................................................................... 12 
6 
Investigational Plan ....................................................................................................................... 13 
7 
Subject Population ......................................................................................................................... 14 
8 
Study CONDUCT and Procedures ................................................................................................ 16 
9 
Test Article and Management ....................................................................................................... 19 
10 
Study Visit Schedule ...................................................................................................................... 21 
11 
Statistical Methods ........................................................................................................................ 23 
12 
Assessment of Safety .................................................................................................................... 24 
13 
Ethics............................................................................................................................................... 26 
14 
REFERENCES ................................................................................................................................. 28 
 
 
 
 

 
 
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4 LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
Abbreviation or Term 
Definition 
AE 
adverse event 
GCP 
Good Clinical Practice  
HIV 
Human Immunodeficiency Virus  
HPV 
human papillomavirus 
ICH 
International Council for Harmonisation 
IEC 
Independent Ethics Committee 
IRB 
Independent Review Board 
KCC 
Kimberly-Clark Corporation  
PID 
Pelvic Inflammatory Disease  
SAE 
serious adverse event 
TSS 
Toxic Shock Syndrome  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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INTRODUCTION 
Feminine hygiene products are used by women throughout the world during their menstrual periods, 
from the onset of menarche until menopause.  These products, which include pads, liners and tampons, 
function to contain and absorb menstrual fluid.  Industrially manufactured tampons were first 
introduced into the US market in 1936.  Since then, billions of tampons have been sold worldwide.   
The primary indication for tampon use is for the absorption of menstrual fluid inside the vagina during 
the menstrual period. Modern tampons have been safely used as a convenient aid in managing 
menstrual discharges. About 90% of all girls in the United States are menstruating by 14 years of age, 
with a median age of approximately 12 years. This age at menarche is not significantly different than 
that reported for girls in the United States 47 years ago.1 The average age for the end of menstruation, 
menopause, is approximately age 52 years among healthy women in United States.2 However, there is 
growing evidence that menarche and menopause may be influenced by health status, ethnicity, genetic 
and socio-economic factors to some extent.1,3 
Tampons are available in various absorbency ranges: light (<6 g), regular (6-9 g), super (9-12 g), super 
plus (12-15 g), and ultra (15-18 g). 
are available in Regular, Super and Super Plus 
absorbencies.  Currently marketed tampons consist of 100% cotton, 100% rayon, or blends of cotton 
and rayon absorbent materials.  Tampons can be manufactured with or without an overwrap (cover).  
Additionally, they are available with different modes of insertion; either they are inserted with the finger 
(digital tampons) or with an applicator.  Material and design changes of marketed tampons may have a 
potential effect on safety.   
The tampons used in this study include a current commercially available
tampon and 
a modified
tampon.  The radially wound design of the current
tampon can 
occasionally lead to an extending (i.e., telescoping or elongation) of the tampon upon removal due, in 
part, to the placement of the string. Kimberly-Clark (K-C) has modified the current
tampon to 
adjust the string placement in an effort to decrease this extension.  This is a design validation study to 
validate the following user needs as they relate to the modified tampon: 1) product to remain clean 
prior to use, 2) product to remain in working condition prior to use, 3) user can access the product, 4) 
user can vaginally insert and place the tampon, 5) user can remove product from the vagina after use, 6) 
user can distinguish between absorbency levels, 7) product absorbs fluid, and 8) packaging is labeled 
properly. 
 
5 TRIAL OBJECTIVES AND PURPOSE 
 
Objective 
The objective of this study is to validate that changes in the design of the
tampons meet defined user needs.   
Primary Endpoint 
The proportion of used tampons that have elongated will be used to assess the following user need: 
 
User can remove product from the vagina after use 
Analysis will be done separately for each absorbency. 
Key Secondary Endpoints 
Diary responses will be used to assess the following user needs: 

 
 
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 
Product to remain clean prior to use  
 
Product to remain in working condition prior to use 
 
User can access the product  
 
User can vaginally insert and place the tampon 
 
User can remove product from the vagina after use 
 
Product absorbs fluid 
Analysis will be done separately for each absorbency.   
Interview responses will be used to assess the following user need: 
 
User is able to distinguish between absorbency levels 
 
Packaging is labeled properly 
Interview responses will only be done for both absorbencies combined. 
Product tolerability will be evaluated through the following measures: 
 
Gynecological exam findings 
 
Frequency and severity of adverse events 
6 INVESTIGATIONAL PLAN 
 
Overall Study Design 
This prospective multi-center, open-label, randomized, cross-over study is designed to validate that 
changes to the design of
tampons meet the following user needs: product 
to be safe, product to remain clean prior to use, product to remain in working condition prior to use, to 
be able to  access the product, to be able to vaginally insert and place the tampon, to be able to remove 
product from the vagina after use, product to absorb fluid, to be able to distinguish between absorbency 
levels, packaging to be labeled properly.   
Subjects will be assigned to one of two arms in the study: a regular absorbency arm or a super 
absorbency arm.  Within each arm, a subset of 60 subjects will undergo gynecological exams prior to 
and following tampon use.   
Subjects will be randomly assigned the order in which to test a new tampon design (test tampon) and a 
currently marketed tampon (reference tampon).  Each tampon type will be used over the course of one 
(1) menstrual cycle.  Subjects will be provided with 16 tampons per menstrual cycle.   
For subjects undergoing gynecological exams, the study consists of 4 visits for each study subject, 2 visits 
for each menstrual cycle: one before and after each menstrual cycle.  The first visit will be both the 
screening and the first pre-use visit.  Pre-use visits will be conducted within 72 hours prior to expected 
menstruation.  Post-use visits are to be completed within 72 hours following the last tampon use for 
that menstrual cycle.  Subjects will undergo gynecological exams at each visit.  Subjects will keep a daily 
diary during menstruation with entries for every tampon use.  Subjects will also collect each used 
tampon to be returned to the clinical site for inspection by study staff to assess tampon integrity.  
Additionally, these subjects will complete an interview during the first visit to assess whether the subject 
can locate key information on the product packaging.   
For the remainder of the subjects, the study will consist of 3 visits for: a screening and pre-use visit, and 
two post-use visits.  Post-use visits are to be completed within 72 hours following the last tampon use 
for that menstrual cycle.  Subjects will keep a daily diary during menstruation with entries for every 

 
 
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tampon use.  Subjects will also collect each used tampon to be returned to the clinical site for inspection 
by study staff to assess tampon integrity. 
 
Duration of subject participation in the study will be approximately 2 months. 
 
Number of Subjects 
The study population consists of 2 arms of approximately 369 females (total 738 subjects), ages 18-49, 
in good general health, in the United States who normally use tampons for menstrual protection, 
menstruate regularly, and do not have a history of Toxic Shock Syndrome (TSS).   
Treatment Assignment 
Subjects will be assigned to one of two arms in the study based on the absorbency of tampon the 
subject uses most often: a regular absorbency arm or a super absorbency arm.  The order of using the 
test and reference tampons will also be randomly assigned.   
Criteria for Study Terminations 
The Sponsor may terminate this study, after informing Investigators, at any time for safety or 
administrative reasons. Investigators will be notified by the Sponsor or designee if the study is placed on 
hold, completed, or closed.  
 
7 SUBJECT POPULATION 
 
The study population consists of 2 arms of approximately 369 females (total 738 subjects), ages 18-49, 
in good general health, in the United States who normally use tampons for menstrual protection, 
menstruate regularly, and do not have a history of Toxic Shock Syndrome (TSS).  One arm will test 
regular absorbency tampons and the other will test super absorbency tampons. Within each of these 
arms, a subset of 60 subjects will undergo gynecological exams before and after product use. 
Subject Inclusion Criteria 
Women who meet all the following inclusion criteria will be eligible for participation in the study: 
1. Willing and able to read and provide written informed consent. 
2. Female in good general health, age 18-49 (inclusive). 
3. Last pap smear was normal in the past 3 years, or a normal pap with a negative HPV in the past 
5 years, or negative HPV in the last five years (age <21 does NOT need a PAP or HPV result) 
based on self-report 
4. History of regular menstrual cycles during the previous 3 months lasting approximately 21-35 
days, including at least 4 days of menstruation, and expecting to menstruate during the study 
period. 
5. Tracks menstruation and able to confidently predict onset of menstruation within 72 hours. 
6. History of use of applicator tampons without discomfort. 
7. Normally use at least 6 tampons for protection during menstruation. 
8. Normally uses regular, super, and/or super plus absorbency tampons for menstrual protection. 

 
 
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9. If uses super plus absorbency, must be willing to wear nothing greater than super absorbency 
for the duration of the study. 
10. Agrees not to use douching substances, vaginal medications, suppositories, or vaginal devices 
for the duration of the study. 
11. [For subjects undergoing gynecological exams only] Agrees not to apply feminine deodorant 
spray, powders, perfumes, wipes, lotions, creams or emollients to the genital area for at least 24 
hours prior to each visit. 
12. Agrees not to try any new products in the vaginal/perineal area two (2) weeks prior to the study 
start and for the duration of the study. 
13. Agrees to the conduct of all study procedures, including gynecological exams (if applicable), and 
agrees to follow all study instructions and return for scheduled appointments. 
14. Has used an acceptable form of birth control for at least one month prior to enrollment and for 
the duration of the study. Acceptable methods include hormonal contraceptive, IUD, tubal 
ligation, partner vasectomy, condom (with or without spermicide), or abstinence. 
Subject Exclusion Criteria 
Women who meet any the following exclusion criteria will NOT be eligible for participation in the study: 
1. Pregnant, lactating or is trying to become pregnant. 
2. Less than six (6) weeks post-partum. 
3. Has a menstrual abnormality (such as oligomenorrhea or amenorrhea). 
4. History of any of the following diagnoses based on self-report: diabetes, active genital herpes 
lesion in last 3 years, Human Immunodeficiency Virus (HIV), Pelvic Inflammatory Disease (PID), 
Toxic Shock Syndrome (TSS). 
5. History of an abnormal pap smear within the last 3 years, positive HPV in the last 5 years, any 
form of gynecological cancer, or gynecological disorder such as fibroids, or endometriosis (by 
self-report).  Participants that have had a history of an abnormal pap smear, but most recent 
pap smear has been normal, may be included. 
6. Has a medical condition which might compromise her immune system functions (such as cancer, 
immunosuppressive therapy, anemia currently being treated under the care of a physician, 
leucopenia, HIV-positive, or organ transplant). 
7. Has used steroid medications (systemic or topical) for fourteen (14) or more consecutive days 
within the last sixty (60) days. 
8. [For subjects undergoing gynecological exams only] Has Type B (petechia, ecchymoses) or C 
(peeling, abrasions, ulcerations, or lacerations) lesions on the perineum, vulva, urethra, vagina, 
or cervix as determined by the investigator at the screening visit. 
9. [For subjects undergoing gynecological exams only] Has Type A (erythema or edema) lesions 
covering >50% of any of the perineum, vulva, urethra, vagina, or cervical locations as 
determined by the investigator at the screening visit. 
10. Has had clinically identified genital warts/lesions and/or urogenital infection (such as bacterial 
vaginosis, Trichomoniasis, yeast infection, Chlamydia trachomatis, Neisseria gonorrhea, or a 
urinary tract infection) within the past 6 weeks. 

 
 
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11. Has a known allergy or sensitivity to components of the investigational products, including 
rayon. 
12. Any other medical condition or history, as determined by the Investigator that could 
compromise the study results or subject safety. 
Subject Withdrawal Criteria 
Subjects may be withdrawn or terminated from the study for any reason and documented as one of the 
following: 
 
1. Emergence of a severe condition such that, in the opinion of the Investigator, continuation in 
the trial would negatively impact the health of the subject.  
2. Personal reasons (e.g., withdrawn consent) 
3. Subject lost to follow-up 
4. Sponsor decision 
5. Clinical trial close-out 
 
The reason for study discontinuation and date of study withdrawal will be documented. 
  
The site staff must document their attempts to contact subjects who are lost to follow-up. 
 
8 STUDY CONDUCT AND PROCEDURES 
 
Subjects will be assigned to one of two arms in the study: a regular absorbency arm or a super 
absorbency arm.  Subjects will be assigned to the regular or super absorbency arm based on the tampon 
absorbency they use most often.  Within each arm, a subset of 60 subjects will undergo gynecological 
exams prior to and following tampon use.   
Subjects will be randomly assigned the order in which to test a new tampon design (test tampon) and a 
currently marketed tampon (reference tampon).  Each tampon type will be used over the course of one 
(1) menstrual cycle.  Subjects will be provided with 16 tampons per menstrual cycle.   
Intended Use of Test Article 
The
Regular, Super, and Super Plus absorbency tampons are over the counter medical 
devices intended to be inserted into the vagina by menstruating females for the absorption of menstrual 
fluid, after which is removed and discarded.  The population of individuals that will use these devices are 
menstruating females of any age.  In the United States, tampons are Class II medical devices per 21 CFR 
884.5470 (Unscented Menstrual Tampons). 
Description of Test Article 
The
tampon is a
tampon in an applicator. The applicator aids in 
insertion of the tampon device into the vagina during menstruation and is removed after deployment. 
The removal of the tampon involves an attached
string which extends externally for 
ease of access.  
The
device consists of a tampon (absorbent core, overwrap cover and withdrawal 
string) in a three-piece applicator individually wrapped in a printed plastic film. The tampon is composed 

 
 
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of a
absorbent core, a
overwrap cover 
that surrounds the
core, and a white or pink rayon/polyester string
to enable tampon removal.
 
The three-piece applicator consists of an outer insertion tube, referred to as the barrel, which has a 
textured grip and closed rounded tip in a petal-like design at the distal end (end of the applicator closest 
to the cervix during tampon insertion). The applicator also includes a short inner tube, referred to as a 
plunger, which snaps into place with a short middle telescopic tube to form an elongated plunger of the 
proper length to expel the tampon from the applicator barrel into the vagina. The applicator barrel holds 
the tampon prior to use, and the withdrawal string of the tampon is threaded through the 
telescope/plunger tube and a portion remains outside the applicator prior to use.
 
The final tampon product was subjected to extensive biocompatibility testing per FDA guidance and 
current ISO 10993 biocompatibility testing guidance for class II medical devices with additional 
assessments for tampons.
This study will include two absorbencies of
tampon: regular and super. 
tampons have been marketed in the United States for more than 10 years.  The composition of 
the modified tampon is the same as described above, but with an adjusted placement of the withdrawal 
string. 
Concomitant Medications 
Medication use within 30 days of Visit 1 and throughout the duration of the subject’s participation will 
be recorded. 
Randomization 
Subjects will be assigned a unique subject identification number by the site at screening. Following 
completion of the screening procedures, eligible subjects will be assigned to either the regular or super 
absorbency arm, based on the tampon absorbency the subject uses most often.  Within each arm, the 
order in which the test and reference tampons will be used will be randomized.  
A randomization schedule that was created by the unblinded biostatistician at
will be 
provided to each site.  Unique subject randomization numbers will be assigned by the site according to 
the site specific randomization schedule.  Randomization numbers should be assigned sequentially 
within each arm. 
 Exam Procedures 
A subset of 60 subjects in each arm will undergo a gynecological examination at each visit.  
Gynecological exams may also be conducted as needed for any subject to assess adverse events.  
 
The following will be included in the exam: 
• 
Symptom assessment 

 
 
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Prior to the vaginal exam, subjects will be asked to complete a short questionnaire 
regarding vaginal symptoms they may be experiencing.  The purpose of this assessment 
is to alert the clinician of any possible conditions that may need to be addressed for the 
health of the subject and that may affect eligibility. 
 
 
Visual assessment 
This gynecological exam will consist of a visual inspection of the perineum, vulva, 
urethra, vagina, and cervix.  Use of a clear speculum and light are expected for this 
exam.  Each anatomical location will be evaluated for lesions.  Each lesion will be 
characterized according to one of the following types4: 
 
Type
Epithelium
Blood 
Vessel 
Description
Coverage
Comment
A
Intact
Intact
☐ Erythema  
☐ Edema 
☐ ≤ 50% 
☐ > 50% 
Provide specific location 
and any other relevant 
findings 
B
Intact
Disrupted
☐ Petechia  
☐ 
Ecchymoses 
☐ ≤ 50% 
☐ > 50% 
C
☐ Disrupted, 
superficial 
☐ Disrupted, deep 
☐ Intact 
☐ 
Disrupted 
☐ Peeling  
☐ Abrasion 
☐ Ulceration 
☐ Laceration 
☐ ≤ 50% 
☐ > 50% 
D
N/A
N/A
☐ Other 
☐ ≤ 50% 
☐ > 50% 
Provide description of the 
lesion, specific location, 
and any other relevant 
findings 
 
Type D lesions can be other lesions not related to epithelial or blood vessel disruption 
such as cysts, polyps, neoplasms, etc.  
Subjects with presence of any Types B or C lesions at baseline will be excluded from the 
study.  Subjects with a Type A lesion (erythema or edema) may be included as long as 
the coverage area is ≤ 50%.  Subjects with Type D lesions will be excluded at the 
discretion of the investigator. 
Superficial epithelial disruption does not penetrate into the subepithelial tissue. Deep 
epithelial disruption penetrates into and exposes the subepithelial tissue and possibly 
blood vessels. If bleeding from the finding is present, the disruption should be recorded 
as deep5. 
Lesions identified after the screening visit will be considered adverse events.  Severity is 
determined by disruption of the epithelium and blood vessels.  Lesions with an intact 
epithelium and intact blood vessels are considered mild (Types A).  Any lesion that has a 
deep disruption in the epithelium is considered severe (Type C with deep epithelial 
disruption).  All others are considered moderate (Type B and Type C with superficial 
epithelial disruption).  Severity of “Other” (Type D) lesions will be determined by the 
Investigator. 
 
Vaginal discharge  

 
 
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The quantity, odor, color, and consistency of the vaginal discharge will be assessed 
during the vaginal exam by the investigator to determine whether a vaginal infection is 
suspected. 
 
Vaginal pH 
Vaginal pH measurements should be taken using pH testing strips and instructions 
provided. The testing strips measure pH in increments of 0.5, with a minimum range of 
4.5 – 7.5. 
 
Suspected infection 
A subject who has symptoms of a vaginal infection or urinary tract infection at screening 
is not eligible to participate in the study. If a subject develops a vaginal infection or UTI 
during the study, she will stop using the study product and switch to menstrual pads.  
The subject may be treated by the investigator or referred for treatment at the 
discretion of the investigator. Subjects may continue using study product after 
treatment is complete and symptoms have resolved, if appropriate for the study design. 
Development of vaginal infections after screening are recorded and analyzed as adverse 
events. 
 
 
Other abnormal findings  
Any other abnormal findings during the vaginal examination will be recorded.  Subjects 
may be excluded for abnormal findings. Abnormal findings recorded after the screening 
visit will be recorded and analyzed as adverse events. 
Tampon Assessment Procedures 
Each used tampon will be collected within a clear plastic sealable bag and frozen until returned to the 
study site.  Tampons will be collected by study staff, removed from the bag, and photographed using 
standardized photography set-up.  Study staff will measure elongation of each used tampon using a 
provided calibrated ruler.  If elongation occurs, measurements will be taken to the nearest mm from the 
base of the tampon to the furthest point of the absorbent material protruding from the base.  If no 
elongation occurs, a value of 0 mm will be recorded. Any measurement >10 mm will be considered 
elongation.   
9 TEST ARTICLE AND MANAGEMENT 
 
Test Article(s) 
 
Modified
Tampons (test tampons) 
o Regular Absorbency – Code Letter: BR 
o Super Absorbency –  Code Letter: BS 
 
Commercial
Tampons (reference tampons) 
o Regular Absorbency – Code Letter: CR 
o Super Absorbency – Code Letter: CS 
Test Article Packaging and Labeling 

 
 
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All test articles will be packaged in boxes resembling commercial
tampon packaging.  
Each box will contain 16 tampons and a commercial product insert containing general tampon usage 
instructions, as well as applicable safety information.  Each box will minimally contain the following 
information: 
 
study number 
 
applicable test article code letters (BR, BS, CR, or CS) 
 
absorbency level 
 
quantity of the contents  
 
the name and place of business of the manufacturer 
 
the statement, "CAUTION - Investigational device. Limited by Federal (or United States) law to 
investigational use."  
 
Test Article Accountability 
With each shipment of test articles, investigative sites will receive a copy of the study material packing 
listing the details of the contents of the shipment. Investigative sites should sign and date the enclosed 
packing list and verify receipt of the shipment.  The original signed packing list should be retained in the 
site’s regulatory document repository. Packing lists will be reviewed, and any items received by the site, 
including their lot numbers and code letters, will be documented in the accountability log. Copies of the 
accountability log will be monitored for completeness and accuracy.  
 
Test Article Dispensation, Collection, and Management 
The following items will be dispensed to the subject at the visit prior to product use: 
 
1 box of tampons according to the randomization schedule 
 
1 used tampon collection kit containing the following: 
o 16 small clear sealable individual used tampon collection bags  
o 1 medium sized red sealable bag to collect all individually sealed tampon bags  
 
1 diary containing study instructions and diary entry forms for each tampon used 
 
1 cooler bag (dispense 1 per subject for the entire study) 
 
1 freezer pack 
 
1 large opaque white drawstring bag used to return the cooler bag containing the red tampon 
collection bag, completed diary, and any unused tampons to the site 
Subjects will collect each used tampon and place it in a clear bag, labeled with the following 
information: 
 
Study Number 
 
Subject Number 
 
Menstrual Cycle (1 or 2) 
 
Tampon Number (e.g., #1, #2, #3, etc.) 
 
Tampon Code (CR, CS, BR, or BS) 
Each of the clear bags containing a used tampon will be placed inside of the single red sealable bag and 
placed in the freezer until returned to the clinic. The red bag will be labeled with the following 
information:  
 
Study Number 
 
Subject Number  
 
Menstrual Cycle (1 or 2) 

 
 
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 
Tampon Code (CR, CS, BR, or BS) 
If a subject is not at home at the time of tampon removal, the subject can place the tampon in the clear 
collection bag in the cooler bag provided until the subject returns home and can place it in the red bag 
in the freezer. 
Following the last tampon use, subjects will return to the clinic, with the following items in the white 
drawstring bag provided: 
 
cooler bag containing the red tampon collection bag with all used tampons 
 
completed diary 
 
all unused tampons. 
Study staff will document the number of used and unused tampons collected, verify that there is a diary 
entry for each used tampon, verify the accuracy and completeness of diary entries, and address and 
document any discrepancies. 
10 STUDY VISIT SCHEDULE 
 
Subjects will be assigned to one of two arms in the study: a regular absorbency arm or a super 
absorbency arm.  Within each arm, a subset of 60 subjects (Subset Population) will undergo 
gynecological exams prior to and following tampon use.  The study visit schedule is the same for both 
arms of the study. 
For subjects in the Subset Population, the study will consist of 4 visits for each study subject, 2 visits for 
each menstrual cycle: one before and after each menstrual cycle.   
For all other subjects, the study will consist of 3 visits: a screening and pre-use visit, and two post-use 
visits.   
Pre-use visits will be conducted within 72 hours prior to expected menstruation.  Post-use visits are to 
be completed within 72 hours following the last tampon use for that menstrual cycle. 
The schedule of visits and timing of procedures are summarized in the Proposed Schedule of Events 
(Table 1 - Proposed Schedule of Events). 
Visit 1 – Screening/Baseline/Pre-Use Visit 
For all subjects, Visit 1 will include the following: 
 
Signing of informed consent 
 
Review of inclusion and exclusion criteria 
 
Collection of demographic information 
 
Review of medical history 
 
Review of concomitant medications 
 
Questionnaire to determine type of tampon used historically 
 
Randomization 
 
Test article dispensation 
 
Diary training 

 
 
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For all subjects in Subset Population, Visit 1 will also include the following:  
 
Gynecological symptom assessment 
 
Gynecological exam (visual inspection, infection assessment, vaginal discharge, and vaginal pH) 
 
Packaging/labeling interview 
Visit 2 – Post-Use Visit 
For all subjects, Visit 2 will include the following: 
 
Test article collection (used and unused products) 
 
Diary review 
 
Test Article dispensation (if not in the Subset Population) 
 
Diary dispensation (if not in the Subset Population) 
 
Diary re-training, if needed 
 
Tampon integrity assessment 
 
Adverse event collection 
For all subjects in Subset Population, Visit 2 will also include the following: 
 
Gynecological symptom assessment 
 
Gynecological exam (visual inspection, infection assessment, vaginal discharge, and vaginal pH) 
Visit 3 – Pre-Use Visit  
Visit 3 is only required for the Subset Population. It will include the following: 
 
Gynecological symptom assessment 
 
Gynecological exam (visual inspection, infection assessment, vaginal discharge, and vaginal pH) 
 
Test Article dispensation 
 
Diary dispensation 
 
Diary re-training, if needed 
Visit 4 – Post-Use Visit 
For all subjects, Visit 4 will include the following: 
 
Test article collection (used and unused products) 
 
Diary review 
 
Tampon integrity assessment 
 
Adverse event collection 
For all subjects in Subset Population, Visit 4 will also include the following: 
 
Gynecological symptom assessment 
 
Gynecological exam (visual inspection, infection assessment, vaginal discharge, and vaginal pH) 
 

 
 
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11 STATISTICAL METHODS 
 
Sample Size 
 
The sample size was calculated for a single absorbency and is based on the assumption that 0.7% of 
reference tampons elongate (>10 mm) upon removal and 0.2% of test tampons elongate upon removal.  
An estimated yield of 43.75% was used, where yield is the number of usable tampons for the elongation 
analysis divided by the total number of products given to the subjects (i.e., yield means the percentage 
of tampons given to each subject that were used and can be included in the elongation analysis).  It is 
assumed that subjects are given 16 reference tampons and 16 test tampons and use 7 tampons in each 
cycle.  
 
With a power of 80% and 2-sided alpha of 0.05, assuming 2 tampon types tested (reference and test) 
and each subject receiving 16 products per cycle, a total of 369 subjects will need to be enrolled in the 
study for each absorbency.  Since there are 2 absorbencies the study will enroll 738 subjects. 
 
For each absorbency this translates into needing a total of 5,166 used tampons (2,583 used tampons for 
each tampon type (reference and test)).  
 
 
Analysis Populations 
 
Intent-to-Treat (ITT): Subjects randomized into the study. 
 
Safety: ITT subjects who insert at least 1 tampon 
 
Modified Intent-to-Treat (MITT): Safety subject who returns at least 1 tampon that can be assessed for 
elongation. 
 
Primary Endpoint 
 
The proportion of used tampons that have elongated will be used to assess the following user need: 
 
User can remove product from the vagina after use   
Analysis will be done separately for each absorbency for the MITT population. 
Key Secondary Endpoints 
Diary responses will be used to assess the following user needs: 
 
Product to remain clean prior to use  
 
Product to remain in working condition prior to use 
 
User can access the product  
 
User can vaginally insert and place the tampon 
 
User can remove product from the vagina after use 
 
Product absorbs fluid 
Analysis will be done separately for each absorbency using the Safety population.   
Interview responses will be used to assess the following user needs: 

 
 
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 
User is able to distinguish between absorbency levels 
 
Packaging is labeled properly 
Interview responses will only be done for both absorbencies combined for the ITT population. 
Product tolerability will be evaluated through the following measures: 
 
Gynecological exam findings 
 
Frequency and severity of adverse events 
Analysis will be done separately for each absorbency using the Safety population.   
 
Validation Criteria 
The primary objective of this study is to validate that changes in the design of the
tampons meet defined user needs.  The primary objective will have been met if the following 
criteria are met: 
 
Test tampon elongation rate is the same as or better than the reference tampon for each 
absorbency, where same is defined as test tampon elongation rate ≤ reference tampon 
elongation rate . 
 
Product tolerability is deemed to be acceptable based on review of the results. 
 
Diary responses have ≥ 96% response rates consistent with each user need for each absorbency.  
If the rate is lower than 96%, the response rate consistent with the user need related to the test 
tampon must be the same as or better than the response rate of the reference tampon, where 
same is defined as test tampon response rate ≥ reference tampon response rate.   
 
Interview responses demonstrate that 95% of users are able to identify key information on the 
package and insert, and able to distinguish between absorbency levels on the wrappers. 
 
12 ASSESSMENT OF SAFETY 
 
Anticipated Risks 
The risks associated with study participation are similar to those previously identified with all tampons, 
including adverse tissue reactions, vaginal injury, vaginal infection, pain, discomfort, allergy, and Toxic 
Shock Syndrome (TSS).  
Definition of Adverse Event  
An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs 
(including an abnormal laboratory finding) in a clinical investigation subject,  whether or not related to 
the investigational medical device. 
Definition of Serious Adverse Event 
Seriousness is based on subject/event outcome or action criteria usually associated with events that 
pose a threat to a subject’s life or functioning.  An SAE is defined as any untoward medical occurrence 
that falls into one of the following categories: 
 
Results in death 
 
It is immediately life-threatening 

 
 
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 
It requires in-patient hospitalization or prolongation of existing hospitalization 
 
It results in persistent or significant disability or incapacity 
 
Results in a congenital abnormality or birth defect 
 
Intervention required to prevent permanent impairment 
 
It is an important medical event that may jeopardize the subject or may require medical 
intervention to prevent one of the outcomes listed above. 
All SAEs that occur after any subject has been enrolled, before treatment, during treatment, or within 7 
days following the cessation of treatment, whether or not they are related to the study, must be 
recorded on forms provided by Kimberly-Clark. 
Definition of an Unanticipated Adverse Device Effect (UADE) 
An UADE is defined as any serious adverse effect on health or safety, or any life-threatening problem or 
death caused by, or associated with a device, if that effect, problem, or death was not previously 
identified in nature, severity, or degree of incidence in the investigational plan or application, or any 
other unanticipated serious problem associated with a device that relates to the rights, safety, or 
welfare of subjects. 
Recording Adverse Events 
Adverse events spontaneously reported by the subject and/or in response to an open question from the 
study personnel or revealed by observation will be recorded during the study at the investigational site.  
Information about AEs will be collected from the Test Article Dispensation until the end of the study.  
Serious Adverse Event information will be collected from Test Article Dispensation until 7 days following 
Visit 4 (Post-use Visit).  The AE term should be reported in standard medical terminology when possible.  
For each AE, the investigator will evaluate and report the onset (date and time), resolution (date and 
time), intensity, frequency, relationship to test article, action taken, serious outcome (if applicable), and 
whether or not it caused the subject to discontinue the study. 
Intensity will be assessed according to the following scale: 
 
Mild (awareness of sign or symptom, but easily tolerated) 
 
Moderate (discomfort sufficient to cause interference with normal activities) 
 
Severe (incapacitating, with inability to perform normal activities) 
It is important to distinguish between serious and severe AEs.  An AE of severe intensity may not be 
considered serious. 
Relationship to test article will be assessed according to the following scale: 
 
Not Related - A clearly evident relationship to other etiologies exists and/or the event is not 
temporally consistent with test article use. 
 
Unlikely - Based upon available information, a causal relationship to test article is improbable.  
Usually, another cause is most plausible. 
 
Possible - Event follows a reasonable temporal association with test article use and is 
clinically/biological plausible.  Other etiologies are also possible.  
 
Probable - A reasonable temporal sequence of the event with test article use exists and based 
upon the medical professional’s clinical experience, the association of the event with test article 
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 
Definite - Event is clearly related to article use.  It is temporally associated with test article use, 
follows a known or expected response pattern, and improves when stopping test. Other causes 
do not appear to explain the event. 
Reporting Adverse Events 
All SAEs (related and unrelated) will be recorded from the Test Article Dispensation until 7 days 
following Visit 4 (Post-use Visit).  Any SAEs considered possibly or probably related to the investigational 
product and discovered by the Investigator at any time after the study should be reported.  All SAEs 
must be reported to Kimberly-Clark within one business day of the first awareness of the event.  The 
Investigator must complete, sign and date the SAE pages, verify the accuracy of the information 
recorded on the SAE pages with the corresponding source documents, and send a copy by email  to the 
Medical Monitor at
 Additional follow-up information, if required or available, 
should all be emailed to the Medical Monitor within one business day of receipt and this should be 
completed on a follow-up SAE form and placed with the original SAE information and kept with the 
appropriate section of the CRF and/or study file. 
Kimberly-Clark is responsible for notifying the relevant regulatory authorities of certain events.  It is the 
Principal Investigator’s responsibility to notify the IRB or IEC of all SAEs that occur at his or her site.  
Investigators will also be notified of all unexpected, serious, adverse device effects that occur during the 
clinical trial.  Each site is responsible for notifying its IRB or IEC of these additional SAEs. 
Collection and Reporting of Commercial Product Complaints 
A Product Complaint is defined as any written, electronic, or oral communication that alleges 
deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of 
a device after it is commercially available. Upon the return of the Study Diary, each entry will be 
reviewed for completeness and possible AEs.  Any potential AEs will be assessed, documented, and 
reported according to the defined serious and non-serious adverse event reporting parameters outlined 
above.   
Any SAE possibly, probably, or definitely related to a commercially available test product (codes CR and 
CS) will be evaluated for reportability to applicable regulatory agencies by Kimberly-Clark according to 
the Safety Monitoring Plan. 
The Medical Monitor will be notified of all non-serious AEs that are possibly, probably, or definitely 
related to a test product upon entry of the data into the electronic data capture (EDC) system.    Those 
AEs that are related to a commercially available test product (codes CR and CS) will be evaluated for 
reportability to applicable regulatory agencies by Kimberly-Clark according to the Safety Monitoring 
Plan. 
The Medical Monitor will be notified of potentially reportable complaints related to commercially 
available test products that are not associated with an AE upon entry of the diary data into the EDC 
system.  Kimberly-Clark will evaluate for reportability to applicable regulatory agencies as documented 
in the study Safety Monitoring Plan.  
All other non-reportable complaints will be reviewed by Kimberly-Clark in aggregate following 
completion of the study report. 
13 ETHICS 
 
Ethics Review 

 
 
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The final study protocol, including the final version of the Informed Consent Form, must be approved or 
given a favorable opinion in writing by an IRB or IEC as appropriate.  The investigator must submit 
written approval to Kimberly-Clark or designee before he or she can enroll any subject into the study. 
The Principal Investigator is responsible for informing the IRB or IEC of any amendment to the protocol 
in accordance with local requirements.  In addition, the IRB or IEC must approve all advertising used to 
recruit subjects for the study.  The protocol must be re-approved by the IRB or IEC upon receipt of 
amendments and annually, as local regulations require. 
Ethical Conduct 
The Investigator will ensure that this study is conducted in full conformity with Regulations for the 
Protection of Human Subjects of Research codified in21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 812, 
and the ICH E6.  
Written Informed Consent 
Informed consent will be obtained in accordance with International Council for Harmonisation-Good 
Clinical Practice, US Code of Federal Regulations for Protection of Human Subjects (21 CFR 50.25[a,b], 
CFR 50.27, and CFR Part 56, Subpart A), the Health Insurance Portability and Accountability Act (HIPAA), 
if applicable, and local regulations. 
The Principal Investigator(s) at each center will ensure that the subject is given full and adequate oral 
and written information about the nature, purpose, possible risk and benefit of the study.  Subjects 
must also be notified that they are free to discontinue from the study at any time.  The subject should 
be given the opportunity to ask questions and allowed time to consider the information provided. 
The subject’s signed and dated informed consent must be obtained before conducting any study 
procedures. 
The Principal Investigator(s) must maintain the original, signed Informed Consent Form.  A copy of the 
signed Informed Consent Form must be given to the subject. 
 
 

 
 
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14 REFERENCES 
1. Chumlea WC, Schubert CM, Roche AF, Kulin HE, Lee PA, Himes JH, Sun SS. Age at menarche and 
racial comparisons in US girls., Pediatrics. 2003 Jan;111(1):110-3. 
https://doi.org/10.1542/peds.111.1.110 (last accessed 18 Jan 2022) 
2. Shifren, J.L., Gass, M.L.S., for the NAMS Recommendations for Clinical Care of Midlife Women 
Working Group. (2014). The North American Menopause Society Recommendations for Clinical 
Care of Midlife Women. Menopause; 21(10): 1038–1062. doi: 10.1097/GME.0000000000000319   
3. Luoto R1, Kaprio J, Uutela A., Age at natural menopause and sociodemographic status in Finland. 
Am J Epidemiol. 1994 Jan 1;139(1):64-76 doi: 10.1093/oxfordjournals.aje.a116936. 
4. Harwood, B, et al.  Cervicovaginal colposcopic lesions associated with five Nonoxynol-9 vaginal 
spermicide formulations.  Am J Obstet Gynecol. 2008;198(1): 32.e1–32.e7. 
doi:10.1016/j.ajog.2007.05.020 
5. CONRAD/WHO. Manual for the Standardization of Colposcopy for the Evaluation of Vaginal 
Products, Update 2000. Geneva: CONRAD/WHO; 2000. CONRAD/2000.1, WHO/RHR/00.11