Health Condition 1: N809- Endometriosis, unspecified
Conditions
Interventions
Intervention1: Dydrogesterone Sustained Release Tablets 30 mg & Placebo Tablets: Patients will be advised to take one tablet thrice a day orally, swallowed with water in the morning, afternoon and eve
Sponsors
Ravenbhel Healthcare Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female patients of aged between 18-45 years (both inclusive). 2. Patients diagnosed with endometriosis based on imaging studies i.e., USG. 3. Patients with endometriosis associated pelvic 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 all the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with intolerance, contraindication or potential allergy/hypersensitivity to Dydrogesterone. 2. Patients with laparoscopic surgery for endometriosis within 6 months before screening. 3. Female patients who are pregnant or lactating or planning to become pregnant during the study period. 4. Females who are not ready to use acceptable contraceptive methods during study. 5. Patients with previous use of hormonal agents (e.g., GnRH agonists = 6 months, Danazol = 3 months or oral contraceptives = 1 month before screening). 6. Patients who have achieved menopause or have premature ovarian insufficiency. 7. Patients undergoing treatment for infertility by assisted reproductive technologies or any other procedure. 8. 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. 9. Patients with any other significant concomitant gynecological disorder (fibroid etc.). 10. Patients 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. 11. Patients regularly using analgesics not intended to relieve endometriosis associated chronic pelvic pain (e.g., using analgesics for osteoarthritis etc.). 12. Patients with hepatic dysfunction (SGOT & SGPT = 3 X Upper Normal Limit) or renal dysfunction (serum creatinine = 2.5 mg/dL). 13. Patients with any abnormality detected on ECG at the time of screening. 14. Patients with history of drug or alcohol abuse. 15. Patients with medical history of oncological conditions. 16. Patients with known case of HIV, Hepatitis B & C. 17. Patients with concurrent participation in another clinical trial within 30 days prior to signing informed consent. 18. Patients currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period. 19. Patients with suspected inability or unwillingness to comply with the study procedures. 20. Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in endometriosis associated pelvic pain from baseline to end of the study, assessed by a visual analogue scale (VAS; 0 mm means absence of pain, 100 mm means unbearable pain).Timepoint: At Screening Visit (Visit 1), Visit 2 (Day 1 / Baseline), Visit 3 (Day 30±3), Visit 4 (Day 60±3) and Visit 5 (Day 90±3). | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events / serious adverse events reported during the study.Timepoint: Throughout the study.;Changes in clinical laboratory parameters from screening to end of the study visit.Timepoint: At Screening Visit (Visit 1) and Visit 5 (Day 90±3).;Changes in the health-related quality of life using the HRQoL-4 questionnaire from baseline to end of the study.Timepoint: At Visit 2 (Day 1 / Baseline), Visit 3 (Day 30±3), Visit 4 (Day 60±3) and Visit 5 (Day 90±3).;Consumption of rescue pain medication for endometriosis associated pelvic pain from baseline to end of the study.Timepoint: At Visit 3 (Day 30±3), Visit 4 (Day 60±3) and Visit 5 (Day 90±3).;Mean change in the serum vascular endothelial growth factor (VEGF) from baseline to end of the study.Timepoint: At Screening Visit (Visit 1) and Visit 5 (Day 90±3).;Reduction in the size of the endometrioma as calculated by the Ultrasound sonography (USG) from baseline to end of the study.Timepoint: At Screening Visit (Visit 1) and Visit 5 (Day 90±3). | — |
Countries
India
Contacts
Public ContactDr Rajasekhara Reddy Tamma
Clinwave Research Pvt. Ltd.
Outcome results
None listed