Clinical Trial

Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy

Study acronym: PRO-MHT
Not Yet Recruiting
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Summary
Menopause is a natural stage in a woman's life that can be associated with symptoms such as hot flashes, night sweats, sleep problems, and vaginal dryness. Menopausal hormone therapy is commonly used to relieve these symptoms. In women with an intact uterus, progesterone must be used together with estrogen to protect the lining of the uterus. The purpose of this study is to compare two commonly used progesterone treatment methods in women receiving menopausal hormone therapy. All participants will use transdermal estradiol gel, and they will be randomly assigned to receive either oral dydrogesterone or vaginal micronized progesterone. This prospective randomized controlled study will evaluate the effects of these treatments on endometrial thickness, menopausal symptoms, vaginal health parameters, bleeding patterns, and quality of life over a 12-month follow-up period. The results of this study may help determine the most appropriate progesterone regimen for women undergoing menopausal hormone therapy.
Trial Details
NCT Number NCT07496294
Lead Sponsor Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Conditions Menopausal Women, Menopausal Symptom Relief, Hormone Therapy, Menopausal Hormone Therapy
Enrollment 200 participants
Start Date 2026-04
Primary Completion 2027-10 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2026-03-27