Health Condition 1: N809- Endometriosis, unspecified
Conditions
Interventions
Intervention1: Medroxyprogesterone Acetate SR Tablets 30 mg: Each patient will be receiving three tablets in a day (one tablet in morning, one tablet in afternoon and one tablet in evening) for 90 day
Sponsors
Synokem Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female patients of aged between 18-45 years (both inclusive). 2. Patients diagnosed with endometriosis associated with pain based on imaging studies i.e., USG. 3. Patients with endometriosis associated with pain having a score of at least 30 mm on a 100 mm visual analog scale. 4. Patients having agreed to the use of double barrier contraception (use of the male condom along with either diaphragm, cervical cap, or copper T IUD). 5. Patients with ability to understand and provide written informed consent form, which must have been obtained prior to screening. 6. Patients willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients who are hypersensitive to Medroxyprogesterone Acetate or any of its components. 2. Patients with laparoscopic surgery for endometriosis within 6 months before enrollment / screening. 3. Has clinical laboratory evaluations (including biochemistry and hematology) are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator. 4. Female patients who are pregnant or lactating or planning to become pregnant during the study period. 5. Females who are not ready to use acceptable contraceptive methods during the course of study. 6. Women suffering from infertility issues. 7. Presence of Chocolate Cyst in the ovary greater than 3 cm in diameter. 8. Patients with history of blood clots related disease: Deep vein thrombosis, pulmonary embolism and stroke. 9. Before menarche or after menopause. 10. Amenorrhea (more than three consecutive months before screening). 11. Patients with previous use of hormonal agents (e.g. GnRH agonists 12. Patients with abnormal uterine bleeding. 13. Patients with known case of clinically significant cerebrovascular disease, cardiovascular disease, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, hypertension, collagen disorders, severe infections, that may affect patient safety. 14. Patients with any abnormality detected on ECG at the time of screening. 15. Patients with known case of type 1 diabetes and type 2 diabetes mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than 8%. 16. Patients with clinically significant impaired hepatic function. [SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 1.5X the UNL]. 17. Patients with estimated glomerular filtration rate (eGFR) 18. Patients with dyslipidemia. 19. Patients with history of wasting disease, autoimmune disease, connective tissue disease, osteoporosis or use of anticonvulsants or corticosteroids. 20. Patients with history of drug or alcohol abuse within the previous 2 years. 21. Patients with medical history of oncological conditions since last 5 years. 22. Patients with known case of HIV, Hepatitis B & C. 23. Concurrent participation in another clinical trial within 90 days prior to signing informed consent. 24. Currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period. 25. Suspected inability or unwillingness to comply with the study procedures. 26. Patients with clinically significant disorder that, in the opinion of the investigator, would result in jeopardizing patientâ??s safety and efficacy of the drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in endometriosis associated pain from baseline to end of the study, assessed by a visual analogue scale.Timepoint: Baseline, Day 1, Day 15, Day 30, Day 60 and Day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Resistive Index (RI) and Pulsatility Index (PI) of ovarian blood flow.Timepoint: Day 15, Day 30, Day 60 and Day 90.;Changes in the levels of Vascular Endothelial Growth Factor (VEGF) from baseline to end of the study.Timepoint: Baseline and Day 90.;Consumption of rescue pain medication from baseline to end of the study.Timepoint: Day 15, Day 30, Day 60 and Day 90.;Reduction in the size of the endometrioma as calculated by the Ultrasound sonography (USG) from baseline to end of the study (more than 25% will be taken as effective).Timepoint: Baseline, Day 30, Day 60 and Day 90. | — |
Countries
India
Contacts
Public ContactRahul Vij
Synokem Pharmaceuticals Ltd.
Outcome results
None listed