Contraceptive Effectiveness and Safety of the SILCS Diaphragm

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.

Conditions

• Contraception

Interventions

DEVICE

SILCS Diaphragm

SILCS Diaphragm used with 5 ml gel

COMBINATION_PRODUCT

Nonoxynol-9 Gel

Gynol II (2% N-9 gel)

COMBINATION_PRODUCT

Buffer Gel

Buffer Gel

Sponsors & Collaborators

• United States Agency for International Development (USAID)

  collaborator FED

• FHI 360

  collaborator OTHER

• ReProtect Inc

  collaborator INDUSTRY

• CONRAD

  lead OTHER

Principal Investigators

• Ron Frezieres, MSPH · Californial Family Health Council, Inc

• Mitch M Creinin, MD · University of Pittsburgh

• Lynn Bradley, M.Sc. · John Hopkins Community Physicians

• David Archer, MD · Eastern Virginia Medical School

• Alfred Poindexter, MD · Advances in Health, Inc.

• Kurt Barnhart, MD · University of Pennsylvania

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-01-31

Primary Completion

2009-10-31

Completion

2009-11-30

Countries

• United States

Study Locations