Study of the Effectiveness of Dydrogesterone in the Treatment of Endometriosis-related Pain

NCT ID: NCT06952296

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2026-06-30

Brief Summary

The study is an observational, multicenter, prospective, single arm study to evaluate the efficacy of dydrogesterone in endometriosis-related pain (EAP).

Conditions

Endometriosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Dydrogesterone group

Dydrogesterone

Intervention Type: DRUG

The duration of treatment with dydrogesterone is determined by the physician before inclusion in the study and will last for 6 menstrual cycles ("Cycle" used in the protocol refers to menstrual cycle. 1 cycle is 28 days on average)

Interventions

Dydrogesterone

The duration of treatment with dydrogesterone is determined by the physician before inclusion in the study and will last for 6 menstrual cycles ("Cycle" used in the protocol refers to menstrual cycle. 1 cycle is 28 days on average)

Intervention Type: DRUG

Eligibility Criteria

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 that may affect the assessment of pain intensity at the investigator's judgment.
• With any metabolic and genetic diseases that may affect pregnancy and fetus at the investigator's judgment.
• With contraindications for dydrogesterone treatment listed in the locally approved label (instructions for the medical use of Duphaston®).
• Other conditions that made the patient's participation impossible (based on the investigator's decision).
• Fertility treatments requiring assisted reproductive technology.
• Patients simultaneous participating in any interventional clinical study during observation period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Tony Piha, MD MBA

Role: CONTACT

Phone: +41 614870907

Email: tony.piha@abbott.com

Other Identifiers

DYDR-524-0516

Identifier Type: -

Identifier Source: org_study_id