Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy

Menopausal hormone therapy (MHT) is widely used for the treatment of vasomotor symptoms and genitourinary symptoms associated with menopause. In women with an intact uterus, progestogens must be administered together with estrogen therapy to prevent endometrial hyperplasia. Different progesterone formulations and routes of administration are available, including oral and vaginal preparations. However, comparative data regarding the clinical effects and endometrial safety of different progesterone regimens combined with transdermal estradiol are limited. This prospective randomized controlled trial aims to compare two commonly used progesterone regimens in women receiving menopausal hormone therapy. All participants will receive transdermal estradiol gel and will be randomly assigned to one of two treatment groups: oral dydrogesterone or vaginal micronized progesterone. The study will follow participants for approximately 12 months. The primary outcome of the study is endometrial thickness measured by transvaginal ultrasonography. Secondary outcomes include menopausal symptoms, quality of life assessed by validated questionnaires, vaginal health parameters such as vaginal maturation index and vaginal pH, bleeding patterns recorded in bleeding diaries, carotid intima-media thickness, and bone mineral density measurements. The findings of this study are expected to contribute to the identification of the most appropriate progesterone regimen for women undergoing menopausal hormone therapy.