Status:
COMPLETED
MonaLisa Touch Randomized Double-Blind Placebo Controlled Study
Lead Sponsor:
Michigan Institution of Women's Health PC
Conditions:
Genitourinary Syndrome of Menopause
Eligibility:
FEMALE
Phase:
NA
Brief 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.
Detailed Description
Study design: Randomly assigning the intervention can eliminate the influence of unknown or immeasurable confounding variables that may otherwise lead to biased and incorrect estimate of treatment eff...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2019
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03331328
Start Date
September 13 2017
End Date
July 10 2019
Last Update
August 14 2019
Active Locations (1)
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1
Advanced Urogynecology of Michigan, P.C.
Dearborn, Michigan, United States, 48124