Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy (NCT07496294) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy
Turkey (Türkiye)200 participantsStarted 2026-04
Plain-language summary
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.
Who can participate
Age range
45 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Endometrial Thickness
Timeframe: 12 months
Trial details
NCT IDNCT07496294
SponsorSehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital