N95.1
Conditions
Interventions
Group 1: Intervention: Use of Frieda Menova app as an add-on to care as usual for 12 weeks
Group 2: Control: Receive the treatment according to care as usual for 12 weeks
Sponsors
Frieda Health
Eligibility
Sex/Gender
Female
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 40 to 65 years (inclusive) 2. Biologically female 3. Participants must have physician-confirmed natural perimenopause, menopause, or postmenopause, defined as follows: Perimenopausal: Experiencing menopausal symptoms accompanied by irregular menstruation or the absence of menstruation for less than 12 months, with no evident physiological or pathological cause and no clinical intervention. Menopausal or Postmenopausal: Absence of menstruation for 12 consecutive months or more, with no evident physiological or pathological cause and no clinical intervention. 4. Menopause symptoms defined as a score of = 9 in the MenopauseRating Scale II (MRS II) at screening 5. Hot flushes/night sweats should be experienced as problematic as indicated by an average score of = 4 on the Hot Flush Rating Scale (HFRS) Problem Rating Subscale 6. If the participant is taking non-prescription medications (over-the-counter medicines, herbal remedies, or dietary supplements), they must be on a stable regimen for at least 3 months prior to enrolment 7. Fluent in German 8. Access to the internet and smartphone access (version requirements Android =8 and iOS =15) with no difficulty in using mobile applications / using applications/smartphones 9. Able to understand and comply with the Clinical Investigator Plan (CIP) requirements and procedures. 10. Willing and able to provide informed consent before admission to the study
Exclusion criteria
Exclusion criteria: 1. Any treatment-induced menopause, including surgical bilateral salpingo-oophorectomy or treatment. 2. Systemic hormone replacement therapy within last 6 months 3. Hormone substitution (including oral, intradermal, transdermal contraceptives and hormone-releasing intrauterine devices) or endocrine diseases (except for taking medication for thyroid disorders). Diabetes mellitus is permitted and does not qualify as an exclusionary endocrine disorder. 4. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial. 5. Medical or mental condition for which in the opinion of the investigator, the participant will not be able to complete questionnaires independently or to adhere to instructions or procedures outlined in the study CIP 6. Regular use of psychiatric medication, tranquillisers, or neurostimulants, including NK-1/3 receptor antagonists 7. Pregnancy or breastfeeding 8. Women undergoing endocrine therapy for breast cancer, uterine conditions, or other malignancy 9. Women with a history of malignancy who have received fertility-affecting therapies 10. History of alcohol or substance abuse or dependence in the 12 months before screening as determined by the investigator. 11. Cognitive behavioural therapy (CBT) in the past 6 months 12. Use of similar digital treatment in the past 6 months or planned use of similar digital treatment during the course of the study which may have an impact on the study analysis 13. Enrolled in another clinical trial of an investigational drug or treatment device or have received treatment on another clinical trial within the last 90 days
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The following secondary endpoints will be assessed, comparing between-group differences from baseline (t0) to 12 weeks (t2) on impact on sleep, vasomotor symptom frequency, Self-efficacy, stress, and climacteric symptoms. | — |
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will assess the difference in changes of participant reported in HFNS symptoms of HFRS score at baseline (t0 ) and 12 weeks (t2) between the intervention and control groups. | — |
Countries
Germany
Contacts
Public ContactAmy Moore
Lindus Health Limited
Outcome results
None listed