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NCT06308614 · ClinicalTrials.gov registry record · Phase 2
Estetrol for the Treatment of Female Sexual Arousal Disorder in Postmenopausal Women
A Phase 2 study of Sexual Dysfunction, Physiological, sponsored by Estetra.
- Completed
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
- 20
- Study locations
NCT06308614: Completed Phase 2 study of Sexual Dysfunction, Physiological, sponsored by Estetra.
NCT06308614 is a Phase 2 study of Sexual Dysfunction, Physiological that has completed, run by Estetra. The registered enrollment target is 82 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06308614, a Phase 2 study of Sexual Dysfunction, Physiological, has completed, sponsored by Estetra.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this clinical trial is investigating estetrol (E4) in women after menopause, suffering from sexual arousal disorder. The main question it aims to answer is: is 20 mg estetrol monohydrate effective in the treatment of sexual arousal disorder in women after their menopause. Participants will visit the clinic 7 times and complete a daily diary while receiving estetrol or placebo for 12 weeks. Placebo is a pill that looks the same as estetrol but has no active ingredient. Researchers will compare estetrol and placebo to see if estetrol has an effect on the sexual arousal of the participants.
Primary Outcome
The Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) is a validated 15-item self-assessment where each item is scored from 0 (never) to 4 (always). Higher scores on this scale, which has a total range of 0-60, indicate greater distress. Item 14 assesses how often the subject has felt concerned by difficulties with sexual arousal during the past 30 days.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG 20 mg estetrol monohydrate
Study Locations (20)
Florida
- Estetra Study Site - Jacksonville
- Estetra Study Site - Miami
- Estetra Study Site - New Port Richey
- Estetra Study Site - Ocoee
- Estetra Study Site - Orlando
- Estetra Study Site - West Palm Beach
Arizona
- Estetra Study Site - Mesa
- Estetra Study Site - Phoenix
- Estetra Study Site - Tucson
California
- Estetra Study Site - Pomona
- Estetra Study Site - San Diego
Ohio
- Estetra Study Site - Cleveland
- Estetra Study Site - Englewood
Georgia
- Estetra Study Site - Atlanta
Illinois
- Estetra Study Site - Chicago
Nebraska
- Estetra Study Site - Omaha
Nevada
- Estetra Study Site - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2024-01-29 |
| Est. Completion | 2025-04-21 |
| Phase | Phase 2 |
What the finished NCT06308614 record still lists
NCT06308614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 1 condition, with Sexual Dysfunction, Physiological appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06308614 names 20 study sites across 11 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT06308614 about?
NCT06308614 is a clinical study titled "Estetrol for the Treatment of Female Sexual Arousal Disorder in Postmenopausal Women". The goal of this clinical trial is investigating estetrol (E4) in women after menopause, suffering from sexual arousal disorder. The main question it aims to answer is: is 20 mg estetrol monohydrate effective in the treatment of sexual arousal disorder in women after their menopause. Participants wi...
What is the current status of trial NCT06308614?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2024-01-29. Estimated completion is 2025-04-21.
What conditions does trial NCT06308614 study?
This clinical trial studies the following conditions: Sexual Dysfunction, Physiological.
What interventions are being tested in trial NCT06308614?
The interventions under investigation include: Placebo (OTHER), 20 mg estetrol monohydrate (DRUG).
Who is sponsoring clinical trial NCT06308614?
This trial is sponsored by Estetra, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06308614 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06308614's enrollment target sits among peer trials
82 830th of 2000 higher than 1,167 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
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