Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dydrogesterone 10 MG Oral Tablet, Micronized progesterone 200 MG, Transdermal estradiol.
- Who it may be relevant to
- Registry conditions: Menopausal Women, Menopausal Symptom Relief, Hormone Therapy, Menopausal Hormone Therapy. Basic parameters: 45 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Oral Dydrogesterone and Vaginal Micronized Progesterone Regimens Combined With Transdermal Estradiol in Menopausal Hormone Therapy: A Prospective Randomized Controlled Trial
Overview
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.
Detailed description
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.
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.
Primary outcome measures
- Endometrial Thickness [Time frame: 12 months]
Secondary outcome measures (5)
- Menopause-Specific Quality of Life (MENQOL) Score [Time frame: Baseline and 12 months]
- Vaginal Maturation Index [Time frame: Baseline and 12 months]
- Vaginal Symptom Score (Visual Analog Scale, VAS) [Time frame: Baseline and 12 months]
- Vaginal pH [Time frame: Baseline and 12 months]
- Number of bleeding and spotting days and proportion of participants with amenorrhea [Time frame: Throughout the 12-month study period]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital — Istanbul
Publications
- 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
Identifiers
NCT: NCT07496294 · AYANOGLU-MHT-RCT-2026