Clinical study to evaluate efficacy and safety ofDydrogesterone 20 mg Tablets Compared toDydrogesterone 10 mg tablet in the Management Of Endometriosis

Phase 3

Completed

• Conditions: Health Condition 1: 1- Obstetrics

• Registration Number: CTRI/2024/04/065082
• Lead Sponsor: Ms Abbott India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 230

Inclusion Criteria

1. Women of the age group 18 to 45 years (both ages inclusive).

2. Subjects with endometriosis and chronic pelvic pain, with or without dysmenorrhea, including subjects with post-surgical recurrence of endometriosis after 6 months of surgery

2.1. chronic pelvic pain assessed by a score of 30 mm on a 100 mm visual analog scale (VAS)

2.2. clinically and ultrasound diagnosed endometriosis3. Willing to give written informed consent and comply with the study procedures

Exclusion Criteria

1. Any concomitant severe disease or genital disorder or any other condition requiring continuous medical treatment

2. Regular use of analgesics not intended to relieve endometriosis-related chronic pelvic pain.

3. Pregnancy or lactating women or lactating within 3 months of enrollment

4. Not ready to use acceptable contraceptive methods during study

5. Menopause or premature ovarian insufficiency

6. Contraindications to treatment with Dydrogesterone

7. Intake of any experimental drug or participated in another trial in the past 30 days prior to screening

8. Hepatic dysfunction (Serum transaminase=3 × Upeer normal limit) or renal dysfunction (Serum creatinine =2.5 mg/dL)

9. Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurologic/psychiatric, allergy, recent major surgery ( < 3 months), or other relevant diseases as revealed by history, physical examination and/or laboratory assessments

which could limit participation in or completion of the study

10. Known allergic reactions to progesterone products

11. Continuing history of alcohol and/or drug abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in the intensity of chronic pelvic pain from baselineTimepoint: At baseline, 30th day, 60th Day & 91st Day.

Secondary Outcome Measures

Name	Time	Method
1. Change in Health-related Quality of Life (HR-QoL) <br/ ><br>2. Change in the use of analgesics <br/ ><br>3. SafetyTimepoint: 3 months