NCT02309554

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: CONRAD · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

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: 1. 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. 2. 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.

Conditions

• Contraception

Interventions

Type	Name	Description
OTHER	SILCS diaphragm used with ContraGel	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.
OTHER	SILCS diaphragm used with 3% Nonoxynol-9	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.
OTHER	SILCS diaphragm	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

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-12-05
• Last updated: 2016-08-01

Locations

2 sites across 2 countries: United States, Dominican Republic