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NCT03568604 · ClinicalTrials.gov registry record · Phase 4
Changes to Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Prasterone in Women With Dyspareunia
A Phase 4 study of Dyspareunia, sponsored by San Diego Sexual Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT03568604 is a Phase 4 study of Dyspareunia that has completed, run by San Diego Sexual Medicine. The registered enrollment target is 18 participants, below the 71-participant average among 10 other Dyspareunia trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03568604, a Phase 4 study of Dyspareunia, has completed, sponsored by San Diego Sexual Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
Open label study at a single research center. Subjects meeting inclusion and exclusion criteria will receive 6.5 mg prasterone vaginal inserts daily for twenty weeks. A physical examination and vulvoscopy with photography of the vulva, vestibule, urethral meatus and vagina will be performed at baseline and every 4 weeks for 20 weeks. Pain diaries will be completed between visits.
Conditions Studied
Interventions
- DRUG Prasterone
Study Locations (1)
California
- San Diego Sexual Medicine - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-08-07 |
| Est. Completion | 2020-01-28 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03568604
The ClinicalTrials.gov registry entry for NCT03568604 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 71-participant average among 10 other Dyspareunia trials with a reported enrollment target (75% lower). The listed sponsor is San Diego Sexual Medicine, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Dyspareunia appearing as the primary indexed condition, and to 1 intervention - of which Prasterone is the first listed.
NCT03568604 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03568604 about?
NCT03568604 is a clinical study titled "Changes to Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Prasterone in Women With Dyspareunia". Open label study at a single research center. Subjects meeting inclusion and exclusion criteria will receive 6.5 mg prasterone vaginal inserts daily for twenty weeks. A physical examination and vulvoscopy with photography of the vulva, vestibule, urethral meatus and vagina will be performed at basel...
What is the current status of trial NCT03568604?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 18 participants. The study started on 2018-08-07. Estimated completion is 2020-01-28.
What conditions does trial NCT03568604 study?
This clinical trial studies the following conditions: Dyspareunia.
What interventions are being tested in trial NCT03568604?
The interventions under investigation include: Prasterone (DRUG).
Who is sponsoring clinical trial NCT03568604?
This trial is sponsored by San Diego Sexual Medicine, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03568604 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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