Status:
COMPLETED
The Menopause After Cancer Study
Lead Sponsor:
University College Dublin
Collaborating Sponsors:
Irish Cancer Society
Big Health Inc.
Conditions:
Menopause
Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This study will recruit women with vasomotor symptoms of menopause and a prior cancer diagnosis, for whom conventional menopausal hormone therapy (MHT) is contraindicated for any reason. This study wi...
Detailed Description
Patients who are eligible and provide informed consent will be enrolled into this single arm study. Patients will be prescribed non-hormonal pharmacotherapy tailored to the timing of their predominant...
Eligibility Criteria
Inclusion
- Females over 18 years of age at the time of recruitment and onboarding.
- Vasomotor symptoms of menopause
- Previous or current cancer diagnosis
- Conventional menopausal hormone therapy contraindicated for any reason
- Can speak and read English proficiently
- Competent using the internet and has access to smartphone or similar device
Exclusion
- ECOG performance status \>3
- Use of study medications to manage menopausal symptoms in the preceding 6 months
- Use of CBT for insomnia in the preceding 6 months
- Any contraindication to study medications
- No internet access or competency issue with internet use
- Unable to complete questionnaires or give informed consent
- Current major mental illness
Key Trial Info
Start Date :
June 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT04766229
Start Date
June 21 2021
End Date
November 30 2022
Last Update
January 6 2023
Active Locations (2)
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1
Mater Misericordiae University Hospital
Dublin, Ireland
2
St. Vincent's University Hospital
Dublin, Ireland