Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy

Официальное название

Comparison of Oral Dydrogesterone and Vaginal Micronized Progesterone Regimens Combined With Transdermal Estradiol in Menopausal Hormone Therapy: A Prospective Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Dydrogesterone 10 MG Oral Tablet
  Oral dydrogesterone will be administered in combination with transdermal estradiol as part of menopausal hormone therapy.
• Препарат Micronized progesterone 200 MG
  Vaginal micronized progesterone will be administered in combination with transdermal estradiol as part of menopausal hormone therapy.
• Препарат Transdermal estradiol
  Transdermal estradiol gel will be used as estrogen therapy in both treatment groups.

Первичные конечные точки

• Endometrial Thickness [Срок оценки: 12 months]

Вторичные конечные точки (5)

• Menopause-Specific Quality of Life (MENQOL) Score [Срок оценки: Baseline and 12 months]
• Vaginal Maturation Index [Срок оценки: Baseline and 12 months]
• Vaginal Symptom Score (Visual Analog Scale, VAS) [Срок оценки: Baseline and 12 months]
• Vaginal pH [Срок оценки: Baseline and 12 months]
• Number of bleeding and spotting days and proportion of participants with amenorrhea [Срок оценки: Throughout the 12-month study period]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital — Istanbul

Публикации

• Graham S, Archer DF, Simon JA, Ohleth KM, Bernick B. Review of menopausal hormone therapy with estradiol and progesterone versus other estrogens and progestins. Gynecol Endocrinol. 2022 Nov;38(11):891-910. doi: 10.1080/09513590.2022.2118254. Epub 2022 Sep 8. PMID 36075250
• Hipolito Rodrigues MA, Gompel A. Micronized progesterone, progestins, and menopause hormone therapy. Women Health. 2021 Jan;61(1):3-14. doi: 10.1080/03630242.2020.1824956. Epub 2020 Sep 21. PMID 32957843

Идентификаторы

NCT: NCT07496294 · AYANOGLU-MHT-RCT-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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