Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 450 participants
Start Date 2008-01
Est. Completion 2009-11
Phase Phase 2

Sponsor

CONRAD

33 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.