A study to examine the effect of Dydrogesterone Extended Release Tablets 30 mg for the treatment of endometriosis associated pain in women.

Phase 3

Completed

• Conditions: Health Condition 1: N809- Endometriosis, unspecified

• Registration Number: CTRI/2023/06/053743
• Lead Sponsor: Zydus Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-11-04
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 228

Inclusion Criteria

1. Female patients of age 18-45 years (both inclusive).

2. Patients diagnosed with endometriosis based on USG.

3. Patients with endometriosis associated pain score of at least 30mm on 100mm visual analog scale.

4. Patients willing to give written informed consent and comply with the study procedures.

Exclusion Criteria

1. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception.

2. Patients who have achieved menopause or have premature ovarian insufficiency.

3. Patients undergoing treatment for infertility by assisted reproductive technologies or any other procedure.

4. Patients with laparoscopic surgery for endometriosis within last 6 months.

5. Patients who have taken hormone therapy (danazol, progestins or other sex hormones, corticosteroids, GnRH analogs or gestrinone) in last 6 months or oral contraceptives in last 3 months.

6. Patients regularly using analgesics not intended to relieve endometriosis-related chronic pelvic pain (e.g. using analgesics for osteoarthritis etc).

7. Patients with any other significant concomitant gynecological disorder (fibroid etc).

8. Subjects with active or recent (within 6 months) arterial thromboembolic disease (e.g. angina, myocardial infarction) or venous thromboembolism (deep vein thrombosis, pulmonary embolism) or at high risk of venous or arterial thrombosis.

9. Subjects with hepatic dysfunction (serum transaminases = 3 x Upper Normal Limit) or renal dysfunction (serum creatinine = 2.5 mg/dl).

10. Subjects with any other clinically significant uncontrolled systemic diseases such as gastrointestinal, respiratory, cardiovascular, renal, neurological, psychiatric, endocrine (diabetes), immunological or hematological disorders or malignancy.

11. Subjects with continuing history of alcohol and/or drug abuse.

12. Subjects with history of allergy to Dydrogesterone or other similar hormonal products.

13. Participation in another clinical trial in the past 3 months prior to screening.

14. Any other reason for which the investigator feels that patient should not participate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified