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Changes to Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Prasterone in Women With Dyspareunia

NCT03568604 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-06-09

No results posted yet for this 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

  • Dyspareunia

Interventions

DRUG

Prasterone

6.5 vaginal insert prasterone (dehydroepiandrosterone)

Sponsors & Collaborators

  • San Diego Sexual Medicine

    lead OTHER

Principal Investigators

  • Irwin Goldstein, MD · San Diego Sexual Medicine

  • Sue W Goldstein, BA, CCRC · San Diego Sexual Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-07
Primary Completion
2020-01-28
Completion
2020-01-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03568604 on ClinicalTrials.gov