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Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy

Sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

About this trial

Last updated 2 months ago

Study ID

AYANOGLU-MHT-RCT-2026

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

45 to 60 Years
Female

Trial Timing

Started 2 months ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

* Women aged 45-60 years

* Postmenopausal status (absence of menstruation for ≥12 months)

* Intact uterus

* Presence of menopausal symptoms requiring menopausal hormone therapy

* Willingness to participate and provide written informed consent

Exclusion Criteria

* Unexplained vaginal bleeding

* History of breast cancer or endometrial cancer

* Known hypersensitivity to study medications

* History of thromboembolic disease (e.g., deep vein thrombosis or pulmonary embolism)

* Severe liver disease

* Uncontrolled hypertension

* Any condition that, in the opinion of the investigator, makes participation inappropriate