Health Condition 1: N711- Chronic inflammatory disease of uterus
Conditions
Interventions
Intervention1: Dydrogesterone Extended Release Tablets 20mg: Patients will dispensed 2 boxes of medication (each containing 3 strips
of 10 tablets each)
one box for the morning dose and another box for the evening
dose during visit 2, visit 3 and visit 4.A placebo
tablet will be used for evening dose for the patients enrolled in the test group.
Cont
one box for the morning dose and another box for the
evening dose during visit 2, visit 3 and visit 4.
Sponsors
Zydus Healthcare Limited
Clinical Research Network India CRO
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 scaleTimepoint: 90 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Consumption of rescue pain medication for endometriosis associated pelvic 2)pain during the study period in the two groups 3)Change in size of Endometrioma from baseline to end of study as assessed by USG 4)Change in serum VEGF levels from baseline to the end of the study in the two groups 5)Changes from baseline in the health-related quality of life using the HRQoL-4 questionnaire in the two groups at the end of the studyTimepoint: 90 Days | — |
Countries
India
Contacts
Public ContactDr. Pavan Daultani
Zydus Healthcare Limited
Outcome results
None listed