CTRI/2023/03/050698
Completed
Phase 3
A phase III clinical trial to assess the efficacy and safety of Dydrogesterone Extended Release Tablets 20mg as compared to Dydrogesterone Tablets 10mg for treatment of endometriosis in women.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Zydus Healthcare Limited
- Enrollment
- 228
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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