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The Menopause After Cancer Study

NCT04766229 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2023-01-06

No results posted yet for this study

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 will examine if the addition of psycho-social support and digital cognitive behavioral therapy (CBT) for insomnia to standard non-hormonal pharmacotherapy can improve quality of life for these women.

Conditions

Interventions

COMBINATION_PRODUCT

Citalopram +/- Gabapentin + Sleepio + support person

All participants will receive citalopram and/or gabapentin to manage vasomotor symptoms of menopause and will get access to digital CBT for insomnia and be asked to identify a support person

Sponsors & Collaborators

  • Irish Cancer Society

    collaborator OTHER

  • Big Health Inc.

    collaborator INDUSTRY

  • myPatientSpace

    collaborator UNKNOWN

  • University College Dublin

    lead OTHER

Principal Investigators

  • Donal Brennan, PhD · UCD Dublin

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-21
Primary Completion
2022-11-30
Completion
2022-11-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • Ireland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04766229 on ClinicalTrials.gov