Clinical trialNCT00578877CompletedPhase 2/PHASE3Interventional

Contraceptive Effectiveness and Safety of the SILCS Diaphragm

SponsorCONRADEnrollment450Contraception

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Alfred Poindexter, MD
Advances in Health, Inc.
Principal Investigator
clinicaltrials.gov ↗
David Archer, MD
Eastern Virginia Medical School
Principal Investigator
clinicaltrials.gov ↗
Kurt Barnhart, MD
University of Pennsylvania
Principal Investigator
clinicaltrials.gov ↗
Lynn Bradley, M.Sc.
John Hopkins Community Physicians
Principal Investigator
clinicaltrials.gov ↗
Mitch M Creinin, MD
University of Pittsburgh
Principal Investigator
clinicaltrials.gov ↗
Ron Frezieres, MSPH
Californial Family Health Council, Inc
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Jan 2008
Primary completion: 31 Oct 2009
Completion: 30 Nov 2009
Last update posted: 16 Mar 2018
Registered enrollment: 450
Registry id: NCT00578877

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.