Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
224
Sex
Women only
Ages
Ages 18 Years and up
Primary completion
2024-12-30
Last update
2025-05-23

What this trial studies

The study explores the impact of a digital app for the self-management of (peri-)menopausal disorders. A total of 224 participants were randomized into an intervention and a control group. Findings indicate that the app offers beneficial effects on menopausal symptoms and menopause-specific quality-of-life. The study also provided valuable insights for the design of future larger trials and highlights the promising potential of the app to enhance individualized care.

Conditions in scope

  • Menopausal and Other Perimenopausal Disorders

Interventions

  • Menopause App (Device) — The menopause app facilitates the implementation of multimodal self-management strategies in the daily routines of individuals with a (peri-)menopausal disorder, through tools such as a symptom diary and guided interactive exercises.

Who can join

Women only · Ages 18 Years and up

Inclusion criteria

  • Legal capacity
  • Residency in Germany
  • Female sex
  • Age ≥18 years
  • Known and medically confirmed (peri-)menopausal disorder (N95.1, N95.3, N95.8, N95.9)
  • Ownership of a smartphone and ability to use it
  • Internet access for app usage and questionnaire completion
  • Email address for registration

Exclusion criteria

  • Changes in hormone therapy within eight weeks before the start of the study and/or planned within the next 12 weeks
  • Changes in antidepressant treatment within eight weeks before the start of the study and/or planned within the next 12 weeks
  • Previous or current access to the Endo-App or other comparable digital health applications, or current active prescription
  • Current participation in other clinical studies

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

CityState / RegionFacilitySite status
Chemnitz Saxony Endo Health GmbH Unknown

Status & timeline

  • Overall status: Completed
  • Study type: Interventional
  • Phase: N/A
  • Start date: 2024-08-09
  • Primary completion: 2024-12-30
  • Last update posted: 2025-05-23
  • First posted: 2025-05-23

Lead sponsor: Endo Health GmbH (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

  • Menopause-specific Quality of Life Questionnaire (MENQOL) (From enrollment (baseline) to the end of treatment at 12 weeks)
    Menopause-specific Quality of Life Questionnaire (MENQOL): Min=1, max=8. Higher scores mean a worse outcome.

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.

Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT06987617 before contacting a site.

ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.