Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study of Dyspareunia, sponsored by San Diego Sexual Medicine.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary objective of this study is to prospectively document, using vulvoscopy with detailed photography, the visible changes to the vulva, vestibule, urethral meatus and vaginal region in menopausal women with moderate to severe dyspareunia using 6.5 mg daily prasterone for twenty weeks, comparing baseline to 20 weeks. Photographs will be assessed by an independent reviewer using a ten-parameter Likert rating scale, the Vulvoscopic Genitourinary Tissue Appearance (VGTA) scale. This scale as
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 |
What the finished NCT03568604 record still lists
NCT03568604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 71-participant average among 10 other Dyspareunia trials with a reported enrollment target (75% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Dyspareunia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03568604's enrollment target sits among peer trials
18 9th of 10 higher than 2 of 10 other Dyspareunia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dyspareunia 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy
RECRUITING · NA
-
VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia
RECRUITING · NA
-
Prospective on Market Patient-reported Outcomes for Milli
ACTIVE NOT RECRUITING
-
Fractional CO2 Laser Therapy for Survivors of Breast Malignancies
COMPLETED · NA
-
Acupuncture for Vulvodynia: A Pre-pilot Study
COMPLETED · NA
-
Acupuncture for the Treatment of Vulvodynia
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01245179 · 18 participants · Phase 1
Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease
- NCT01999361 · 18 participants · NA
Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
- NCT02359825 · 18 participants · Phase 1
Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function
- NCT02870244 · 18 participants · Phase 1
Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI