Health Condition 1: 1- Obstetrics
Conditions
Interventions
Intervention1: Dydrogesterone 20 mg Tablets: 20 mg Dydrogesterone per day taken as 20 mg modified release OD oral tablet continuously for 3 months
Subjects will be required to take one tablet of Dydrogesterone and one tablet of placebo per day orally, swallowed with water in the morning and evening, respectively around same time every day for 90
Sponsors
Ms Abbott India Limited
Eligibility
Inclusion criteria
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
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 ( 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in the intensity of chronic pelvic pain from baselineTimepoint: At baseline, 30th day, 60th Day & 91st Day. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Health-related Quality of Life (HR-QoL) 2. Change in the use of analgesics 3. SafetyTimepoint: 3 months | — |
Countries
India
Contacts
Public ContactDr Shivani Acharya
Abbott India Ltd
Outcome results
None listed