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.
Women aged 45-60 years
Postmenopausal status (absence of menstruation for ≥12 months)
Intact uterus
Presence of menopausal symptoms requiring menopausal hormone therapy
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)
Parallel
Dydrogesterone 10 MG Oral Tablet
DrugOral dydrogesterone will be administered in combination with transdermal estradiol as part of menopausal hormone therapy.
Micronized progesterone 200 MG
DrugVaginal micronized progesterone will be administered in combination with transdermal estradiol as part of menopausal hormone therapy.
Transdermal estradiol
DrugTransdermal estradiol gel will be used as estrogen therapy in both treatment groups.
Endometrial Thickness
Endometrial thickness measured by transvaginal ultrasonography to evaluate endometrial safety during menopausal hormone therapy.
Menopause-Specific Quality of Life (MENQOL) Score
Change in menopause-related quality of life assessed using the Menopause-Specific Quality of Life (MENQOL) questionnaire. The MENQOL is a 29-item questionnaire with scores ranging from 1 to 8 for each item, where higher scores indicate worse menopausal symptoms and lower quality of life.
Vaginal Maturation Index
Assessment of vaginal epithelial maturation through cytological evaluation.
Vaginal Symptom Score (Visual Analog Scale, VAS)
Severity of vaginal symptoms including dryness, irritation, and dyspareunia measured using a Visual Analog Scale (VAS). The VAS ranges from 0 to 10, where 0 indicates no symptoms and 10 indicates the most severe symptoms. Higher scores indicate worse symptom severity.
Vaginal pH
Measurement of vaginal pH as an indicator of vaginal health.
Carotid Intima-Media Thickness
Assessment of carotid artery intima-media thickness using ultrasound.
Bone Mineral Density
Bone mineral density measured using dual-energy X-ray absorptiometry (DEXA).
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