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NCT03287232 · ClinicalTrials.gov registry record · Phase 3
Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
A Phase 3 study of Hypoactive Sexual Desire Disorder, sponsored by EndoCeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 653
- Enrollment target
- 20
- Study locations
NCT03287232: Completed Phase 3 study of Hypoactive Sexual Desire Disorder, sponsored by EndoCeutics.
NCT03287232 is a Phase 3 study of Hypoactive Sexual Desire Disorder that has completed, run by EndoCeutics. The registered enrollment target is 653 participants, above the 322-participant average among 8 other Hypoactive Sexual Desire Disorder trials with a reported enrollment target (103% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03287232, a Phase 3 study of Hypoactive Sexual Desire Disorder, has completed, sponsored by EndoCeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 653 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.
Primary Outcome
Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 \& 2).
Conditions Studied
Interventions
- DRUG Placebo Vaginal Insert
- DRUG Prasterone 6.5 mg (0.50%) Vaginal Insert
Study Locations (20)
Florida
- Endoceutics site # 95 - Bradenton
- Endoceutics site # 120 - Coral Gables
- Endoceutics site # 99 - Fort Myers
- Endoceutics site # 26 - Jacksonville
- Endoceutics site # 60 - Lake Worth
- Endoceutics site #118 - Miami Lakes
- Endoceutics site # 54 - North Miami
- Endoceutics site # 92 - Oviedo
California
- Endoceutics site # 108 - Berkeley
- Endoceutics site # 121 - Los Alamitos
- Endoceutics site #128 - Los Angeles
- Endoceutics site # 30 - San Diego
- Endoceutics site # 17 - San Diego
Alabama
- Endoceutics site # 106 - Huntsville
- Endoceutics site # 104 - Mobile
Colorado
- Endoceutics site # 36 - Denver
- Endoceutics site # 52 - Denver
Arizona
- Endoceutics site # 117 - Tucson
Connecticut
- Endoceutics site # 125 - New London
District of Columbia
- Endoceutics site # 7 - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 653 participants |
| Start Date | 2017-10-16 |
| Est. Completion | 2019-07-22 |
| Phase | Phase 3 |
What the finished NCT03287232 record still lists
NCT03287232 is an interventional study that assigns participants to a tested intervention. The registered 653 participants enrollment target is mid-sized for trials with a published cap, above the 322-participant average among 8 other Hypoactive Sexual Desire Disorder trials with a reported enrollment target (103% higher).
The record links to 1 condition, with Hypoactive Sexual Desire Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo Vaginal Insert is the first listed.
NCT03287232 names 20 study sites across 7 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT03287232 about?
NCT03287232 is a clinical study titled "Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)". The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.
What is the current status of trial NCT03287232?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 653 participants. The study started on 2017-10-16. Estimated completion is 2019-07-22.
What conditions does trial NCT03287232 study?
This clinical trial studies the following conditions: Hypoactive Sexual Desire Disorder.
What interventions are being tested in trial NCT03287232?
The interventions under investigation include: Placebo Vaginal Insert (DRUG), Prasterone 6.5 mg (0.50%) Vaginal Insert (DRUG).
Who is sponsoring clinical trial NCT03287232?
This trial is sponsored by EndoCeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03287232 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03287232's enrollment target sits among peer trials
653 2nd of 8 the highest of 8 other Hypoactive Sexual Desire Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypoactive Sexual Desire Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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