Health Condition 1: N809- Endometriosis, unspecified
Conditions
Interventions
Intervention1: Dydrogesterone Extended Release Tablets 30mg: One Dydrogesterone Extended Release Tablet 30mg in morning and one matching placebo in the afternoon and night at about the same time daily
Sponsors
Zydus Healthcare Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Endometriosis Associated Pelvic Pain (EAPP) from baseline to end of study as assessed on 100mm VAS scale.Timepoint: At Baseline / Visit 2 (Day 0), At Visit 3 (Day 30), At Visit 4 (Day 60) and At Visit 5 (Day 90). | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events / serious adverse events reported during the study.Timepoint: At Baseline / Visit 2 (Day 0), At Visit 3 (Day 30), At Visit 4 (Day 60) and At Visit 5 (Day 90).;Change in serum VEGF levels from baseline to the end of the study in the two groups.Timepoint: At Baseline / Visit 2 (Day 0) and At Visit 5 (Day 90).;Change in size of Endometrioma from baseline to end of study as assessed by USG.Timepoint: At Screening / Visit 1 (Day -3) and At Visit 5 (Day 90).;Changes from baseline in the health-related quality of life using the HRQoL-4 questionnaire in the two groups at the end of the study.Timepoint: At Baseline / Visit 2 (Day 0), At Visit 3 (Day 30), At Visit 4 (Day 60) and At Visit 5 (Day 90).;Consumption of rescue pain medication for endometriosis associated pelvic pain during the study period in the two groups.Timepoint: At Visit 3 (Day 30), At Visit 4 (Day 60) and At Visit 5 (Day 90). | — |
Countries
India
Contacts
Public ContactDr Pavankumar M Daultani
Zydus Healthcare Limited
Outcome results
None listed