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NCT00572377 · ClinicalTrials.gov registry record · Phase 1
Alprostadil (FemLife Gel) in the Treatment of Female Sexual Arousal Disorder
A Phase 1 study, sponsored by Cedars-Sinai Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT00572377 is a Phase 1 study that was terminated before completion, run by Cedars-Sinai Medical Center. The registered enrollment target is 10 participants.
The verdict
NCT00572377, a Phase 1 study, was terminated before completion, sponsored by Cedars-Sinai Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Female sexual arousal disorder (FSAD) is a frequent finding in women in middle age and more prevalent in post-menopausal women. Topical alprostadil is currently under development for the treatment of FSAD. The purpose of this research is to determine if this formula of alprostadil is safe and effective in women with FSAD. We will be comparing alprostadil to placebo. Each participant will be treated for 1 month with active alprostadil and 1 month with placebo without knowing which they are using. This way, the investigators can compare the effects of alprostadil to the effects of an inactive topical gel. Post-menopausal women with FSAD will be recruited. The women interested in participating in the study will first meet with investigators and answer questions to make sure they are eligible for the study and fit the diagnosis of FSAD. Once enrolled, subjects will fill out questionnaires about their medical history, social history, and psychosocial history. They will also undergo medical examination. At this introductory research visit they will fill out baseline questionnaires, give medical history, undergo physical exam and have blood drawn. The informed consent will be reviewed and will be signed by the participant at this time. The subject will then return for the 1st treatment visit at which time vital signs like blood pressure and heart rate will be taken, external genitalia will be examined and study drug will be dispensed after randomly being assigned to either alprostadil or placebo. After instruction, the subject will use first dose in the clinic and be monitored for 2 hours looking for changes in vital signs or local genitalia reaction. If no problems are noted, subject will be sent home with study drug and Female Sexual Encounter Profile Cards (FSEP). The patient will fill out these cards with each sexual encounter. After 1 week patient will be contacted by phone and asked about side effects or concerns. After 4 weeks the subject will return for another
Interventions
- DRUG Placebo
- DRUG FemLife Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2007-05 |
| Est. Completion | 2008-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00572377
The ClinicalTrials.gov registry entry for NCT00572377 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00572377 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00572377 about?
NCT00572377 is a clinical study titled "Alprostadil (FemLife Gel) in the Treatment of Female Sexual Arousal Disorder". Female sexual arousal disorder (FSAD) is a frequent finding in women in middle age and more prevalent in post-menopausal women. Topical alprostadil is currently under development for the treatment of FSAD. The purpose of this research is to determine if this formula of alprostadil is safe and effect...
What is the current status of trial NCT00572377?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2007-05. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00572377?
The interventions under investigation include: Placebo (DRUG), FemLife Gel (DRUG).
Who is sponsoring clinical trial NCT00572377?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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