MonaLisa Touch Randomized Double-Blind Placebo Controlled Study
Completed · Not applicable · Has a placebo group
Conditions studied: Genitourinary Syndrome of Menopause
In brief
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.
Key facts
- Study ID
- NCT03331328
- Run by
- Michigan Institution of Women's Health PC
- People needed
- 34
- Starts
- 2017-09-13
- Expected to finish
- 2019-07-10
- Last updated by the study team
- 2019-08-14
Who can join
Age: any. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Postmenopausal dyspareunia or vaginal dryness rated from moderate to severe
- Desirous of sexual function
- Menopausal women with absence of menstruation for at least 12 months or those who have had bilateral oophorectomy
- Presence of vaginal atrophy symptoms based upon the vaginal health index assessment < 15 and vagina pH >5
- Prolapse stage < III, according to the pelvic organ prolapse quantification (POP-Q) system
- No pelvic reconstructive surgery within 6 months prior to treatment
- Understanding and acceptance of the obligation to return for all scheduled follow-up visits
You may not qualify if…
- History of vaginal carcinoma or dysplasia, history of vaginal or pelvic radiation
- Acute or recurrent genital infection (e.g. bacterial; vaginosis, herpes genitalis, candida)
- Any serious disease, or chronic condition such as uncontrolled diabetes, that could interfere with the study compliance
- Reconstructive pelvic surgery within the past 6 months
- Have used vaginal estrogen cream, ring or tablet within 3 months prior to entering the study
- Have used vaginal moisturizers, lubricants or homeopathic preparations within 30 14 days of therapy
- Not willing to stop use of any vaginal lubricants or estrogen of any form including phytoestrogens such as Estroven
Where it is running
- Advanced Urogynecology of Michigan, P.C. — Dearborn, Michigan, United States
Full record on ClinicalTrials.gov
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