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NCT03331328 · ClinicalTrials.gov registry record · NA
MonaLisa Touch Randomized Double-Blind Placebo Controlled Study
A NA study of Genitourinary Syndrome of Menopause, sponsored by Michigan Institution of Women's Health PC.
- Completed
- Registry status
- NA
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT03331328: Completed NA study of Genitourinary Syndrome of Menopause, sponsored by Michigan Institution of Women's Health PC.
NCT03331328 is a NA study of Genitourinary Syndrome of Menopause that has completed, run by Michigan Institution of Women's Health PC. The registered enrollment target is 34 participants, below the 381-participant average among 6 other Genitourinary Syndrome of Menopause trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03331328, a NA study of Genitourinary Syndrome of Menopause, has completed, sponsored by Michigan Institution of Women's Health PC.
- COMPLETED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
Aim of the study: To assess the efficacy of MonaLisa Touch procedure for the management of genitourinary syndrome of menopause (GSM) in a randomized double-blind placebo controlled study.
Primary Outcome
Improvement in the most bothersome symptom (MBS) of vulvovaginal atrophy as defined by improvement in dyspareunia. Patients are required to rate the severity of dyspareunia/dryness as none, mild, moderate or severe. The severity score is given a numerical value (none 0, mild 1, moderate 2 and severe 3).
Conditions Studied
Interventions
- DEVICE MonaLisa Touch
Study Locations (1)
Michigan
- Advanced Urogynecology of Michigan, P.C. - Dearborn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2017-09-13 |
| Est. Completion | 2019-07-10 |
| Phase | NA |
What the finished NCT03331328 record still lists
NCT03331328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 381-participant average among 6 other Genitourinary Syndrome of Menopause trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Genitourinary Syndrome of Menopause appearing as the primary indexed condition, and to 1 intervention - of which MonaLisa Touch is the first listed.
NCT03331328 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT03331328 about?
NCT03331328 is a clinical study titled "MonaLisa Touch Randomized Double-Blind Placebo Controlled Study". Aim of the study: To assess the efficacy of MonaLisa Touch procedure for the management of genitourinary syndrome of menopause (GSM) in a randomized double-blind placebo controlled study.
What is the current status of trial NCT03331328?
This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2017-09-13. Estimated completion is 2019-07-10.
What conditions does trial NCT03331328 study?
This clinical trial studies the following conditions: Genitourinary Syndrome of Menopause.
What interventions are being tested in trial NCT03331328?
The interventions under investigation include: MonaLisa Touch (DEVICE).
Who is sponsoring clinical trial NCT03331328?
This trial is sponsored by Michigan Institution of Women's Health PC, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03331328 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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