Study of the Effectiveness of Dydrogesterone in the Treatment of Endometriosis-related Pain (NCT06952296) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study of the Effectiveness of Dydrogesterone in the Treatment of Endometriosis-related Pain
250 participantsStarted 2025-04
Plain-language summary
The study is an observational, multicenter, prospective, single arm study to evaluate the efficacy of dydrogesterone in endometriosis-related pain (EAP).
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female, ≥18 and ≤45 years of age.
* With normal menstrual cycles (according to the International Federation of Gynecology and Obstetrics \[FIGO\]-2018 classification system) in the preceding 6 months before Cycle 0, defined as menstrual frequency ≥24 to ≤38 days, menstrual duration ≤8 days, shortest to longest cycle variation ≤7-9 days, normal flow volume (patient determined) and no intermenstrual bleeding.
* Have clinically or surgically diagnosed endometriosis according to routine clinical practice.
* Complaints of ERP.
* Prescribed treatment with Duphaston® according to the local approved label for treatment of endometriosis 10 mg BID or TID from the 5th to the 25th day of the menstrual period.
* Signed informed consent form (ICF).
Exclusion Criteria:
* With definite diagnosis of adenomyosis confirmed by clinical diagnosis or histopathology.
* Routine consumption of analgesics other than for the pain of endometriosis.
* Patients receiving hormonal treatment (e.g., dienogest, levonorgestrel releasing intrauterine system, dydrogesterone, etc.) or hormonal contraceptives (including intrauterine devices, contraceptive patches, contraceptive rings, oral contraceptives, etc.) during the previous menstrual cycle prior to Cycle 0.
* Ongoing pregnancy.
* Menopause or premature ovarian failure.
* Had surgery within 3 months before enrollment or have planned surgery during the study.
* Any coexisting disease(s) with or without chronic concomitant medication t…
What they're measuring
1
Changes in visual analogue scale (VAS) score of dysmenorrhea, Chronic Pelvic Pain (CPP), dyspareunia, and other Endometriosis related Pain (ERP) after dydrogesterone treatment from baseline to Cycle 6.
Timeframe: From baseline to Cycle 6 ("Cycle" refers to menstrual cycle, 1 cycle is 28 days on average)