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NCT00324948 · ClinicalTrials.gov registry record · Phase 2
Topical Alprostadil for Female Sexual Arousal Disorder
A Phase 2 study, sponsored by VIVUS.
- Completed
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
NCT00324948 is a Phase 2 study that has completed, run by VIVUS. The registered enrollment target is 300 participants.
The verdict
NCT00324948, a Phase 2 study, has completed, sponsored by VIVUS.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
Study Summary
Approximately 300 patients with female sexual arousal disorder who meet eligibility criteria will be enrolled and randomized to receive either active drug or matching placebo. After a two-month, non-treatment period, patients will receive study drug for 6 months and will record information about sexual encounters in a daily diary. Study drug will be applied directly to the genital area 30-60 minutes before initiation of sexual activity. The endpoint of the study is based on the use of a standard measure of sexual function (FSEP).
Interventions
- DRUG Topical alprostadil (PGE-1)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2004-09 |
| Est. Completion | 2006-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00324948
The ClinicalTrials.gov registry entry for NCT00324948 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VIVUS, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Topical alprostadil (PGE-1) is the first listed.
NCT00324948 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00324948 about?
NCT00324948 is a clinical study titled "Topical Alprostadil for Female Sexual Arousal Disorder". Approximately 300 patients with female sexual arousal disorder who meet eligibility criteria will be enrolled and randomized to receive either active drug or matching placebo. After a two-month, non-treatment period, patients will receive study drug for 6 months and will record information about sex...
What is the current status of trial NCT00324948?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2004-09. Estimated completion is 2006-11.
What interventions are being tested in trial NCT00324948?
The interventions under investigation include: Topical alprostadil (PGE-1) (DRUG).
Who is sponsoring clinical trial NCT00324948?
This trial is sponsored by VIVUS, which has 35 total clinical trials registered on ClinicalTrials.gov.
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