An interventional study of Dydrogesterone 10 MG Oral Tablet and Micronized progesterone 200 MG in Menopausal Women, Menopausal Symptom Relief and Hormone Therapy, sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 45 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital · Not applicable, Interventional, and Treatment
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.
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.
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital is the lead sponsor of 41 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive transdermal estradiol gel combined with oral dydrogesterone as the progesterone component of menopausal hormone therapy.
Drug: Dydrogesterone 10 MG Oral Tablet · Drug: Transdermal estradiol
Participants will receive transdermal estradiol gel combined with vaginal micronized progesterone as the progesterone component of menopausal hormone therapy.
Drug: Micronized progesterone 200 MG · Drug: Transdermal estradiol
Oral dydrogesterone will be administered in combination with transdermal estradiol as part of menopausal hormone therapy.
Also known as: Duphaston
Vaginal micronized progesterone will be administered in combination with transdermal estradiol as part of menopausal hormone therapy.
Also known as: Progestan
Transdermal estradiol gel will be used as estrogen therapy in both treatment groups.
Also known as: Femijel
Endometrial Thickness
Endometrial thickness measured by transvaginal ultrasonography to evaluate endometrial safety during menopausal hormone therapy.
Time frame: 12 months
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.
Time frame: Baseline and 12 months
Vaginal Maturation Index
Assessment of vaginal epithelial maturation through cytological evaluation.
Time frame: Baseline and 12 months
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.
Time frame: Baseline and 12 months
Vaginal pH
Measurement of vaginal pH as an indicator of vaginal health.
Time frame: Baseline and 12 months
Number of bleeding and spotting days and proportion of participants with amenorrhea
Bleeding patterns will be evaluated using participant-recorded daily bleeding diaries. The number of bleeding and spotting days will be calculated, and the proportion of participants achieving amenorrhea will be determined.
Time frame: Throughout the 12-month study period
Carotid Intima-Media Thickness
Assessment of carotid artery intima-media thickness using ultrasound.
Time frame: Baseline and 12 months
Bone Mineral Density
Bone mineral density measured using dual-energy X-ray absorptiometry (DEXA).
Time frame: Baseline and 12 months
Plan to share: No — Individual participant data will not be shared due to institutional data protection policies and privacy considerations for study participants.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dydrogesterone · Progesterone
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital