Contraceptive Effectiveness and Safety of the SILCS Diaphragm

Phase 2

Completed

Conditions: Contraception

Interventions: Device: SILCS Diaphragm
Combination Product: Buffer Gel
Combination Product: Nonoxynol-9 Gel

Registration Number: NCT00578877

Lead Sponsor: CONRAD

Brief Summary: This multi-center contraceptive effectiveness and safety study of the SILCS diaphragm will enroll approximately 450 couples at risk for pregnancy at six study sites in the U.S. The study will randomly assign approximately 300 couples to use the SILCS diaphragm with BufferGel and approximately 150 couples to use the SILCS diaphragm with Gynol II (2% N-9 gel). At two sites, a substudy involving colposcopy and microflora will be conducted in about 80 women (40 at each site). The primary objective of this study is to estimate the cumulative 6-month typical-use pregnancy probability for women using the SILCS diaphragm with a contraceptive gel.

Detailed Description: This multi-center contraceptive effectiveness and safety study of the SILCS diaphragm will enroll approximately 450 couples at risk for pregnancy w at six study sites in the U.S. The study will randomly assign approximately 300 couples to use the SILCS diaphragm with BufferGel (BG) and approximately 150 couples to use the SILCS diaphragm with Gynol II (2% N-9 gel). At two sites, a substudy involving colposcopy and microflora will be conducted in about 80 women (40 at each site). For certain evaluations, the data from a contraceptive study conducted by NICHD of the Ortho All-Flex diaphragm used with either BG or N-9 will be used as historical controls.

In the current study, each participant will agree to use the SILCS diaphragm with her assigned contraceptive gel as her only method of contraception for approximately 7 months (at least 190 days) and at least 6 menstrual cycles. Emergency contraception will be offered if unprotected intercourse occurs, according to local prescribing practices.

Each female participant will undergo four scheduled visits: Enrollment, After Cycle 1, After Cycle 3, and Final visits. Two weeks after enrollment, each participant will be called to determine if she has had any problems with the method and to assess compliance.

Recruitment for this study is expected to take about 12 months. Each subject's participation will last about 6-7 months. Site closeout is expected to take three months. The clinical portion of the study should last about 21 months. Data closure and analysis are expected to take three months and the Final Report two additional months.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Buffer Gel	Buffer Gel
Arm 1	Nonoxynol-9 Gel	Gynol II (2% N-9 gel)
Arm 2	SILCS Diaphragm	Buffer Gel
Arm 1	SILCS Diaphragm	Gynol II (2% N-9 gel)

Primary Outcome Measures

Name	Time	Method
Percent Probability of Pregnancy Among Users of the SILCS Diaphragm Used With Contraceptive Gel Over 6 Months of Typical Use	6 months

Secondary Outcome Measures

Name	Time	Method
Percent Women With Urogenital Adverse Events.	6 months	Clinically evaluate the safety of the SILCS diaphragm used with contraceptive gel over 6 months of use.

Trial Locations

Locations (6): California Family Health Council, Inc
🇺🇸
Los Angeles, California, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
John Hopkins Community Physicians
🇺🇸
Baltimore, Maryland, United States
Advances in Health, Inc.
🇺🇸
Houston, Texas, United States
Eastern Virginia Medical School
🇺🇸
Norfolk, Virginia, United States