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NCT07413705 · ClinicalTrials.gov registry record · NA

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

A NA study of Depressive Symptoms and Urinary Incontinence, sponsored by BTL Industries.

Recruiting
Registry status
NA
Development phase
60
Enrollment target
3
Study locations

NCT07413705 is a NA study of Depressive Symptoms and Urinary Incontinence that is actively recruiting participants, run by BTL Industries. The registered enrollment target is 60 participants, below the 261-participant average among 60 other Depressive Symptoms trials with a reported enrollment target (77% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT07413705, a NA study of Depressive Symptoms and Urinary Incontinence, is actively recruiting participants, sponsored by BTL Industries.

RECRUITING
Registry status
NA
Development phase
60 participants
Enrollment target
3
Study locations

Study 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

Interventions

  • DEVICE EXOMIND (BTL-699-2) Active Treatment
  • DEVICE EMSELLA (HPM-6000UF) ActiveTreatment
  • DEVICE EXOMIND (BTL-699-2) Sham Treatment
  • DEVICE EMSELLA (HPM-6000UF) Sham Treatment

Study Locations (3)

Florida

  • Luxury Psychiatry Clinic - Winter Garden

Massachusetts

  • Aesthetic + Mind MD - Wellesley

Ontario

  • Vitality MD Inc - Toronto

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2025-11-20
Est. Completion 2026-12-11
Phase NA

Sponsor

BTL Industries

40 total trials

What the Registry Record Tells You About NCT07413705

The ClinicalTrials.gov registry entry for NCT07413705 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 60 other Depressive Symptoms trials with a reported enrollment target (77% lower). The listed sponsor is BTL Industries, which has 40 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Depressive Symptoms appearing as the primary indexed condition, and to 4 interventions - of which EXOMIND (BTL-699-2) Active Treatment is the first listed.

NCT07413705 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Florida, Massachusetts, Ontario.

Frequently Asked Questions

What is clinical trial NCT07413705 about?

NCT07413705 is a clinical study titled "BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women". 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 th...

What is the current status of trial NCT07413705?

This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-11-20. Estimated completion is 2026-12-11.

What conditions does trial NCT07413705 study?

This clinical trial studies the following conditions: Depressive Symptoms, Urinary Incontinence, Sexual Dysfunction.

What interventions are being tested in trial NCT07413705?

The interventions under investigation include: EXOMIND (BTL-699-2) Active Treatment (DEVICE), EMSELLA (HPM-6000UF) ActiveTreatment (DEVICE), EXOMIND (BTL-699-2) Sham Treatment (DEVICE), EMSELLA (HPM-6000UF) Sham Treatment (DEVICE).

Who is sponsoring clinical trial NCT07413705?

This trial is sponsored by BTL Industries, which has 40 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07413705 being conducted?

This trial has 3 study locations across Florida, Massachusetts, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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