BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women

Recruiting N/A Interventional Study
Depressive Symptoms Urinary Incontinence Sexual Dysfunction
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
40 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
BTL Industries Ltd. · Industry
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About This Trial
The goal of this clinical trial is to evaluate if the combined treatment with EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices is able to improve depressive symptoms and sexual function in women who are perimenopausal or postmenopausal without an alternative medical cause before enrollment in the study and are aged 40 years and older. The main question it aims to answer is: Does the combined t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Menopause defined as 12 consecutive months with no menses without an alternative medical cause or perimenopause defined as occurrence of ≥ 60 days of amenorrhea without an alternative medical cause * Patient Health Questionnaire-9 (PHQ-9) pre-treatment score of ≥ 5 * Age ≥ 40 …
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