Postcoital Testing Study of the SILCS Diaphragm Used With 3% N-9 Gel, ContraGel, or No Gel

Study Overview
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Brief Summary
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This post coital test study is a Phase I multi-center, randomized, crossover, non-significant risk device study to be carried out at two clinical sites/centers. The products to be tested are the SILCS diaphragm with 3% Nonoxynol-9 Gel (N-9) (spermicide), the SILCS diaphragm with ContraGel, and the SILCS diaphragm alone. Participants will be randomized to the order of product use, with a goal of 10 participants completing the study.

Detailed Description
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Each participant will be seen in approximately nine visits, over a period of 6-8 months, and will be contacted approximately 7 days after the final visit. Volunteers will be consented at Visit 1 and undergo procedures to confirm they are eligible to continue in the study. Each participant will undergo four postcoital test (PCT) cycles: The first PCT cycle will be a baseline cycle, done without the use of any product, in order to demonstrate the participant's ability to undergo normal ovulatory events and to produce receptive, midcycle cervical mucus. The partner's ability to produce motile sperm capable of penetrating the cervical mucus is also evaluated in this cycle. Test PCT cycles will be carried out during the subsequent menstrual cycles using either the SILCS diaphragm with 3% N-9, the SILCS diaphragm with ContraGel, or the SILCS diaphragm alone following a sequence of randomized treatment. Cycles may need to be repeated depending on the characteristics of the cervical mucus and the number of sperm found in the vaginal pool and endocervical specimens.

Official Title
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A Phase I Postcoital Testing Study of the SILCS Diaphragm Used With 3% Nonoxynol-9 Gel, ContraGel, or No Gel

Conditions
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Contraception

Intervention / Treatment
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* Other: SILCS diaphragm used with ContraGel
* Other: SILCS diaphragm used with 3% Nonoxynol-9
* Other: SILCS diaphragm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-45 years, inclusive General good health, by volunteer history and per investigator judgment History of regular menstrual cycles of 24-35 days (inclusive), by volunteer report History of Pap smears and follow-up consistent with standard medical practice as outlined in the Study Manual or willing to undergo a Pap smear at Visit 1 Willing to abstain from intercourse and use of vaginal products as required in the protocol Willing to use non-spermicidal, lubricated condoms from the first day of each menstrual cycle until 72 hours before expected midcycle In a mutually monogamous relationship for at least the last four months with a male partner who: 7a. Is at least 18 years old; 7b. Has no known risk for STIs; 7c. Is willing and able to comply with protocol requirements including sexual activity/ abstinence and condom use requirements; and 7d. Can engage in vaginal intercourse with the participant, with and without condoms, as specified in protocol Protected from pregnancy by female tubal sterilization Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to easy genital tract sample collection Willing to give voluntary consent, sign an informed consent form and comply with study procedures as required by the protocol Exclusion Criteria: History of hysterectomy Vasectomy in male partner Sterility or known history of sperm dysfunction in male partner Currently pregnant or within two calendar months from the last pregnancy outcome. Note: If recently pregnant must have had at least two spontaneous menses since pregnancy outcome Current use of any hormonal contraceptive or a copper IUD, or use of Depo-Provera in the last 120 days Currently breastfeeding or having breastfed an infant in the last two months, or planning to breastfeed during the course of the study Significant gynecological abnormalities (including abnormal vaginal bleeding or excessive vaginal discharge) Device does not appropriately fit volunteer, as determined by clinician Inability to insert, position, and/or remove study device, by clinician or volunteer History of sensitivity/allergy to 3% N-9, latex, ingredients in ContraGel, or silicone, for either the volunteer or her male partner In the last six months, either the volunteer or her male partner diagnosed with or treated for any STI or pelvic inflammatory disease. Note: Women with a history of genital herpes or condylomata who have been asymptomatic for at least six months may be considered for eligibility Positive test for Trichomonas vaginalis, Neisseria gonorrhea or Chlamydia trachomatis Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for a sexually transmitted infection Positive test for HIV Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting, etc.) Known current drug or alcohol abuse which could impact study compliance Participation in any other investigational trial within the last 30 days or planned participation in any other investigational trial during the study History of gynecological procedures (including genital piercing) on the external genitalia, vagina or cervix within the last 14 days Abnormal finding on laboratory or physical examination or a social or medical condition in either the volunteer or her male partner which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SILCS Diaphragm alone<br>Participants will complete a post-coital test cycle with SILCS diaphragm alone. | Other: SILCS diaphragm<br>* SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring<br>|
| Active Comparator: SILCS Diaphragm with 3% Nonoxynol-9 Gel<br>Participants will complete a post-coital test cycle with SILCS diaphragm used with 3% nonoxynol-9 gel. | Other: SILCS diaphragm used with 3% Nonoxynol-9<br>* SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring. 3% Nonoxynol-9 (branded as Gynol II) is clear, unscented water soluble greaseless gel packed in plastic tubes with a vaginal applicator.<br>Other: SILCS diaphragm<br>* SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring<br>|
| Experimental: SILCS Diarphragm with ContraGel<br>Participants will complete a post-coital test cycle with SILCS diaphragm used with ContraGel. | Other: SILCS diaphragm used with ContraGel<br>* SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring. ContraGel is a clear, water soluble greaseless gel packed in a metal tube.<br>Other: SILCS diaphragm<br>* SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women with an average of fewer than 5 progressively motile sperm per high powered field (HPF) as a measure of preliminary effectiveness | Fewer than 5% progressively motile sperm per high power field is considered indicative of acceptable barrier function. Will be calculated separately for each test cycle. | 2-3 hours following coitus | 
| Per-women average number (across 9 HPFs) of progressively motile sperm per HPF as a measure of preliminary effectiveness. | Mean, median, standard deviation and IQR will be assessed for the baseline cycle and during each test PCT, across all women. Qualitative assessments of change from baseline, if any, will be based on medians and IQRs. | 2-3 hours following coitus | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment emergent adverse experiences among female participants as a measure of safety | Urogenital, product-related, and/or serious AEs will be assessed | Beginning at Visit 2 through 7-10 days after the final study visit; an average of 6-8 months | 
| Number of treatment emergent adverse experiences among male partners as a measure of safety | Urogenital, product-related, and/or serious AEs will be assessed | Beginning at Visit 2 through 7-10 days after the final study visit; an average of 6-8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Post coital test, Vaginal, Diaphragm