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NOT YET RECRUITING
NCT07496294
NA

Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy

Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

View on ClinicalTrials.gov

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

DRUG

Dydrogesterone 10 MG Oral Tablet

Oral dydrogesterone will be administered in combination with transdermal estradiol as part of menopausal hormone therapy.

DRUG

Micronized progesterone 200 MG

Vaginal micronized progesterone will be administered in combination with transdermal estradiol as part of menopausal hormone therapy.

DRUG

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)