Contraceptive Effectiveness and Safety of the SILCS Diaphragm

Completed · Phase 2/Phase 3

Conditions studied: Contraception

In brief

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.

Key facts

Study ID

NCT00578877

Run by

CONRAD

People needed

450

Starts

2008-01-01

Expected to finish

2009-11-01

Last updated by the study team

2018-03-16

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

Where it is running

• California Family Health Council, Inc — Los Angeles, California, United States
• John Hopkins Community Physicians — Baltimore, Maryland, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Advances in Health, Inc. — Houston, Texas, United States
• Eastern Virginia Medical School — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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