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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SILCS Diaphragm alone | Active Comparator | Participants will complete a post-coital test cycle with SILCS diaphragm alone. |
|
| SILCS Diaphragm with 3% Nonoxynol-9 Gel | Active Comparator | Participants will complete a post-coital test cycle with SILCS diaphragm used with 3% nonoxynol-9 gel. |
|
| SILCS Diarphragm with ContraGel | Experimental | Participants will complete a post-coital test cycle with SILCS diaphragm used with ContraGel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SILCS diaphragm used with ContraGel | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, Eastern Virginia Medical School | Norfolk | Virginia | 23507 | United States | ||
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| ID | Term |
|---|---|
| D017137 | Nonoxynol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
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|
| SILCS diaphragm used with 3% Nonoxynol-9 | Other | 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. |
|
| SILCS diaphragm | Other | 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 |
|
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 |
| ProFamilia |
| Santo Domingo |
| Dominican Republic |
| D009930 |
| Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |