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NCT06952296Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 30 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
250 (estimated)
First submitted
10 Apr 2025
Start date
Apr 2025
Primary completion date
30 Jun 2026
Lead sponsor
Abbott
NCT number
NCT06952296

What you commit to

  • Study type: Observational
  • Planned participants: 250
  • From Apr 2025 to the primary completion date, 30 Jun 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.

Other illness

  • Menopause or premature ovarian failure.
  • With any metabolic and genetic diseases that may affect pregnancy and fetus at the investigator's judgment.
  • Other conditions that made the patient's participation impossible (based on the investigator's decision).

Other

  • With definite diagnosis of adenomyosis confirmed by clinical diagnosis or histopathology.
  • Routine consumption of analgesics other than for the pain of endometriosis.
  • Ongoing pregnancy.
  • With contraindications for dydrogesterone treatment listed in the locally approved label (instructions for the medical use of Duphaston®).
  • Fertility treatments requiring assisted reproductive technology.
  • Patients simultaneous participating in any interventional clinical study during observation period.

Who the study is looking for

  • 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).

Age in the registry: 18 years to 45 years · Sex: Female

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.