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Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy
Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
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.
Official title: Comparison of Oral Dydrogesterone and Vaginal Micronized Progesterone Regimens Combined With Transdermal Estradiol in Menopausal Hormone Therapy: A Prospective Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
45 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-04
Completion Date
2027-10
Last Updated
2026-03-27
Healthy Volunteers
No
Interventions
Dydrogesterone 10 MG Oral Tablet
Oral dydrogesterone will be administered in combination with transdermal estradiol as part of menopausal hormone therapy.
Micronized progesterone 200 MG
Vaginal micronized progesterone will be administered in combination with transdermal estradiol as part of menopausal hormone therapy.
Transdermal estradiol
Transdermal estradiol gel will be used as estrogen therapy in both treatment groups.
Locations (1)
Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
Istanbul, Turkey (Türkiye)