At a glance
ClinicalIndex Comparison Record- ✓Age 18–40 years inclusive
- ✓Healthy, sexually active women at risk for pregnancy and desiring contraception
- ✓Currently have a single sexual partner for at least 4 months who is at low risk for HIV/STI, and expect the same partner for the study duration
- ✓Normal menstrual cycles (24–35 days) over the last 2 months
- ✕Allergy to silicone, nylon, latex, dry natural rubber, spermicides, or N-9 products
- ✕History of toxic shock syndrome (TSS)
- ✕Suspected or diagnosed untreated UTI or vaginitis at enrollment
- ✕History of infertility (including ectopic pregnancy, PID hospitalization, endometriosis without subsequent pregnancy, sterilization, or fertility problems) or pelvic exam abnormalities impairing fertility
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Contraceptive Effectiveness and Safety Study of the SILCS Diaphragm: the Pivotal Study
In Brief
A Phase 3 clinical trial evaluating SILCS Diaphragm, Nonoxynol-9 Gel, and 1 other intervention for Contraception. Completed, enrolled 450 participants across 6 sites.
Detailed 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.
Study Details
Timeline
Interventions
SILCS Diaphragm used with 5 ml gel
Gynol II (2% N-9 gel)
Buffer Gel