RecruitingNot ApplicableNCT07413705

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

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


Sponsor

BTL Industries Ltd.

Enrollment

60 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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 treatment with EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices improve depressive symptoms and urinary incontinence? Participants will be asked to: Undergo twelve treatments Complete the Patient Health Questionnaire-9 Complete the 6-item Hamilton Depression Rating Scale Complete the Greene Climacteric Scale Complete the Therapy Comfort Questionnaire Complete the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form Complete the Female Sexual Function Index Complete the Warwick-Edinburgh Mental Wellbeing Scale Complete the Columbia Suicide Severity Rating Scale-Screen version Complete the Subject Satisfaction Questionnaire Complete the Therapy Comfort Questionnaire


Eligibility

Sex: FEMALEMin Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study tests two non-invasive devices — BTL-699-2 (a brain stimulation device) and HPM-6000UF (a device for pelvic/body stimulation) — to see if they can improve depression symptoms and sexual function in women who are in perimenopause or postmenopause (going through or past menopause). **You may be eligible if...** - You are 40 years old or older - You are in perimenopause (at least 60 days without a period) or postmenopause (12 consecutive months without a period) - You have at least mild depression symptoms (PHQ-9 score of 5 or above) - You are not currently undergoing other treatments for depression or sexual function **You may NOT be eligible if...** - You have metal implants in or near your head, a pacemaker, cochlear implants, or implanted nerve/brain stimulators - You have a seizure disorder or epilepsy - You have active suicidal intent or attempted suicide in the past 3 years - You have been diagnosed with bipolar disorder, a psychotic disorder, or seasonal affective disorder - You are currently abusing substances or were dependent 3 months prior - You have neurological disorders, a history of head trauma, or brain aneurysm - You are currently breastfeeding - You have an active eating disorder (bulimia or anorexia) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEXOMIND (BTL-699-2) Active Treatment

Participants will receive six transcranial magnetic stimulation treatments with the BTL-699-2 device over the left dorsolateral prefrontal cortex. The intensity will be adjusted according to the subject's feedback, up to 70% of the individual's motor threshold. The treatments will be spaced 3 - 7 days apart.

DEVICEEMSELLA (HPM-6000UF) ActiveTreatment

Participants will receive six treatments with the HPM-6000UF device delivered to the pelvic floor musculature. The intensity will be adjusted according to the subject's feedback, up to 100%. The treatments will be spaced 3 - 7 days apart.

DEVICEEXOMIND (BTL-699-2) Sham Treatment

Participants will receive six transcranial magnetic stimulation treatments with the BTL-699-2 device over the left dorsolateral prefrontal cortex. The intensity will be set to 1% of the individual's motor threshold. The treatments will be spaced 3 - 7 days apart.

DEVICEEMSELLA (HPM-6000UF) Sham Treatment

Participants will receive six treatments with the HPM-6000UF device delivered to the pelvic floor musculature. The intensity will be set to 1%. The treatments will be spaced 3 - 7 days apart.


Locations(3)

Luxury Psychiatry Clinic

Winter Garden, Florida, United States

Aesthetic + Mind MD

Wellesley, Massachusetts, United States

Vitality MD Inc

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT07413705


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