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NCT00578877 · ClinicalTrials.gov registry record · Phase 2
Contraceptive Effectiveness and Safety of the SILCS Diaphragm
A Phase 2 study, sponsored by CONRAD.
- Completed
- Registry status
- Phase 2
- Development phase
- 450
- Enrollment target
NCT00578877 is a Phase 2 study that has completed, run by CONRAD. The registered enrollment target is 450 participants.
The verdict
NCT00578877, a Phase 2 study, has completed, sponsored by CONRAD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 450 participants
- Enrollment target
Study 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.
Interventions
- DEVICE SILCS Diaphragm
- COMBINATION_PRODUCT Nonoxynol-9 Gel
- COMBINATION_PRODUCT Buffer Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00578877
The ClinicalTrials.gov registry entry for NCT00578877 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CONRAD, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which SILCS Diaphragm is the first listed.
NCT00578877 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00578877 about?
NCT00578877 is a clinical study titled "Contraceptive Effectiveness and Safety of the SILCS Diaphragm". 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 co...
What is the current status of trial NCT00578877?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 450 participants. The study started on 2008-01. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00578877?
The interventions under investigation include: SILCS Diaphragm (DEVICE), Nonoxynol-9 Gel (COMBINATION_PRODUCT), Buffer Gel (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT00578877?
This trial is sponsored by CONRAD, which has 33 total clinical trials registered on ClinicalTrials.gov.
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