Comparing tibolone and E2V/MPA for menopausal symptoms
The Impact of Different Hormone Therapy Regimens on Overactive Bladder Symptoms, Sexual Function, Depressive Symptoms, Autonomic Function, and Arterial Stiffness
This study is testing whether two different hormone treatments, tibolone and a combination of estradiol valerate and medroxyprogesterone acetate, can help women with menopausal symptoms feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | Far Eastern Memorial Hospital Academic / other |
| Locations | 1 site (Banqiao District, New Taipei) |
| Trial ID | NCT05280028 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of two hormone therapies, tibolone and estradiol valerate combined with medroxyprogesterone acetate (E2V/MPA), on various menopausal symptoms including overactive bladder, sexual function, heart rate variability, arterial stiffness, atherosclerosis, sleep quality, and depressive symptoms. It will involve female patients with intact uteri who are experiencing menopausal symptoms and will utilize a prospective, open-label design. Participants will complete several validated questionnaires to assess their symptoms and overall health outcomes.
Who should consider this trial
Good fit: Ideal candidates are women over 20 years old with menopausal symptoms who have an intact uterus and no history of breast or other cancers.
Not a fit: Patients with a history of breast or other cancers or vascular-blocking diseases such as stroke may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the most effective hormone therapy for alleviating menopausal symptoms in women.
How similar studies have performed: While there is limited literature on tibolone's effects, this study aims to fill a gap in comparative research, suggesting a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>20 years old female * Menopausal symptoms, still have a uterus, and no breast or other cancers, and no vascular-blocking disease such as stroke. Exclusion Criteria: * Nil.
Where this trial is running
Banqiao District, New Taipei
- Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital — Banqiao District, New Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Sheng-Mou Hsiao, MD — Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
- Study coordinator: Sheng-Mou Hsiao, MD
- Email: smhsiao2@gmail.com
- Phone: +8868966700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.