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NCT03116087 · ClinicalTrials.gov registry record · NA
Testosterone Replacement in Postmenopausal Women With Stress Urinary Incontinence
A NA study, sponsored by Charles Drew University of Medicine and Science.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT03116087: Completed NA study, sponsored by Charles Drew University of Medicine and Science.
NCT03116087 is a NA study that has completed, run by Charles Drew University of Medicine and Science. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03116087, a NA study, has completed, sponsored by Charles Drew University of Medicine and Science.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
The overall objective of this study is to establish if testosterone replacement in post-menopausal women with low testosterone levels and stress urinary incontinence (SUI) will lead to improvement in symptoms of SUI. This study is a prospective, randomized, double-blind, placebo-controlled, parallel-group, clinical trial and will involve sixty (60) post-menopausal women with clinically diagnosed stress urinary incontinence and low testosterone concentrations. These subjects will enter the control period, which involves the baseline measurements of pelvic floor muscle volume and strength, amounts of urine leakage in 24-hour period, urodynamic parameters, and quality of life using Incontinence Impact Questionnaire and Urogenital Distress Inventory. Subjects are then randomly assigned to either placebo (30 subjects) or 300 mcg/twice-weekly testosterone patch (30 subjects) group. Both the subjects and investigators will be blinded. The duration of the testosterone/control study will be 36 weeks, with weeks 1-3 screening/control period, 4-28 application of placebo or testosterone patches and 29-36 recovery time/assessment of effects.
Primary Outcome
This outcome will be assessed by MRI, urodynamic studies and pad tests.
Interventions
- DRUG Placebo
- DRUG Testosterone patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2007-03-01 |
| Est. Completion | 2018-05-31 |
| Phase | NA |
What the finished NCT03116087 record still lists
NCT03116087 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03116087 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03116087 about?
NCT03116087 is a clinical study titled "Testosterone Replacement in Postmenopausal Women With Stress Urinary Incontinence". The overall objective of this study is to establish if testosterone replacement in post-menopausal women with low testosterone levels and stress urinary incontinence (SUI) will lead to improvement in symptoms of SUI. This study is a prospective, randomized, double-blind, placebo-controlled, paralle...
What is the current status of trial NCT03116087?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2007-03-01. Estimated completion is 2018-05-31.
What interventions are being tested in trial NCT03116087?
The interventions under investigation include: Placebo (DRUG), Testosterone patch (DRUG).
Who is sponsoring clinical trial NCT03116087?
This trial is sponsored by Charles Drew University of Medicine and Science, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03116087's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
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