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

NCT06952296 | Not Yet Recruiting

• 1 other identifier: DYDR-524-0516
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (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.

  The VAS consists of a 100-mm line with the end points no pain and worst pain, which "absence of pain" corresponds to the value of "0" and unbearable pain corresponding to the value of "100" . Patients will be asked to point the average pain intensity throughout the last menstrual cycle.

  From baseline to Cycle 6 ("Cycle" refers to menstrual cycle, 1 cycle is 28 days on average)

Secondary Outcomes (8)

• 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 3.

  From baseline to Cycle 3 ("Cycle" refers to menstrual cycle, 1 cycle is 28 days on average)

• Changes in Endometriosis Health Profile Questionnaire-30 (EHP-30) after dydrogesterone treatment from baseline to Cycle 3 and Cycle 6.

  From baseline to Cycle 3 and Cycle 6 ("Cycle" refers to menstrual cycle, 1 cycle is 28 days on average)

• Changes in score of pain domain of Endometriosis Health Profile Questionnaire (EHP-30) from baseline to Cycle 3 and Cycle 6.

  From baseline to Cycle 3 and Cycle 6 ("Cycle" refers to menstrual cycle, 1 cycle is 28 days on average)

• Changes in sexual well-being after dydrogesterone treatment by 5-points Likert scale from baseline to Cycle 3 and Cycle 6.

  From baseline to Cycle 3 and Cycle 6 ("Cycle" refers to menstrual cycle, 1 cycle is 28 days on average)

• Changes in menstrual cycle duration from baseline to Cycle 3 and Cycle 6.

  From baseline to Cycle 3 and Cycle 6 ("Cycle" refers to menstrual cycle, 1 cycle is 28 days on average)

Study Arms (1)

Dydrogesterone group

Drug: Dydrogesterone

Interventions

Dydrogesterone 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)

Dydrogesterone group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study is planned to enroll 250 patients who have endometrosis-related pain (ERP) (dysmenorrhea, Chronic pelvic pain (CPP), dyspereunia, and other ERP) and are planned to be treated with dydrogesterone per the physician's decision.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

MeSH Terms

Conditions

Endometriosis

Interventions

Dydrogesterone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Tony Piha, MD MBA

CONTACT

+41 614870907; tony.piha@abbott.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 30, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04