Health Condition 1: N948- Other specified conditions associated with female genital organs and menstrual cycle
Conditions
Interventions
Intervention1: FDC of Relugolix + Estradiol + Norethindrone Acetate (40 mg + 1 mg + 0.5 mg) Tablets: Patients will receive FDC of Relugolix + Estradiol + Norethindrone Acetate (40 mg + 1 mg + 0.5 mg)
Sponsors
AKUMS DRUGS PHARMACEUTICALS LTD
Ms Akums Drugs and Pharmaceutical Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Premenopausal female aged 18 to 50 years old inclusive on the day of signing and dating the informed consent form. 2. Patient with regularly occurring menstrual periods of 3 to 14 days duration with a cycle interval of 21 to 35 days from the start of 1 menstrual period until the start of the next, by participant history for at least 3 months prior to the first screening visit. 3. Confirmed diagnosis of uterine fibroids that is supported by documented evidence either previous or at Screening of transvaginal and or transabdominal ultrasound or CT abdomen or MRI abdomen and have not received any surgical treatment for uterine fibroid and at least one measurable non-calcified myoma with a longest diameter of less than or equal to 3 cm at Screening visit. 4. Patient with heavy menstrual bleeding associated with uterine fibroids as evidenced by a PBAC score more than or equal to 100 which corresponds to MBL more than 80 mL in the previous menstrual cycle at Randomization visit 5. Women of childbearing potential WOCBP must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening or baseline visit. 6. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening. Minimum Education 8th pass. 7. Patients willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patient has a rapidly enlarging uterine fibroid as per Investigatorâ??s opinion and who is planning to undergo gynaecological surgery or ablation procedures for uterine fibroids during the study period. 3. Patients with history or current osteoporosis or other metabolic bone disorder. 4. Patients with history or current clinically significant hypocalcaemia, hypo- or hyperphosphatemia 5. Patients with history of the use of bisphosphonates, calcitonin, calcitriol, teriparatide, denosumab, or any medication other than calcium and vitamin D preparations to treat BMD loss 6. Patients with history or current thyroid disorders 7. Patients with history (documented) of blood disorders 8. Patients with history of allergic or hypersensitive reaction or intolerance to any of the ingredients of relugolix or estradiol or norethindrone acetate or leuprolide or its excipients, that will be used in the study 9. Patients with history of lower abdominal pain due to irritable bowel syndrome or inflammatory bowel disease or severe intestinal cystitis or chronic UTI 10. Patients with history or current or suspected carcinoma breast or any other estrogen-dependent neoplasia 11. Patients with history of malignancy 12. Patients with history of bilateral oophorectomy or hysterectomy 13. Patients with marked intermenstrual bleeding as per Investigators opinion 14. Patients taking contraindicated medications within the last 12 weeks prior to Randomization 15. Patients with uncontrolled hypertension at Screening and Randomization or hypotension at Screening and Randomization 16. Patients with QTcF greater than or equal to 440 milliseconds in 12-lead ECG or any other abnormal ECG findings at Screening and Randomization 17. Patients with a Hb level less than 8.0 g/dL at Screening and Randomization 18. Patients with inadequate hepatic function (total bilirubin greater than or equal to 1.5 X ULN or AST greater than or equal to 3 X ULN or ALT greater than or equal to 3 X ULN) 19. Patients with a history of stroke, thrombotic event, thyroid disorder, convulsion, psychiatric disorder, cardiovascular disease, gastrointestinal, hepatic, renal, pulmonary, auto-immune disease, any active infection, or any other clinically significant condition requiring treatment which at the Investigatorâ??s discretion might interfere with the study 20. Patients who has tested positive for HIV, HBV or HCV at Screening 21. Patient is pregnant or breastfeeding or planning a pregnancy within the next 6 months or less than 6 months postpartum, post-abortion, or post-pregnancy at the time of Screening 22. Patients with history of smoking within the last 3 months prior to Screening 23. Patients with history of alcohol or drug abuse within the last 3 months prior to Screening 24. Patients who have participated in another Investigational study within the 3 months prior to Screening in this study 25. Investigator, study personnel, sponsor representatives and their first-degree relatives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients to achieve PBAC score less than 75 over the last 28 daysTimepoint: Percentage of patients to achieve PBAC score less than 75 over the last 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients to achieve a 50 percent reduction of PBAC scoreTimepoint: Baseline to Week 12;Percentage of patients to achieve amenorrheaTimepoint: Baseline to Week 12;Time to achieve amenorrheaTimepoint: Baseline to Week 12;Percentage change from baseline in PBAC score over the last 28 daysTimepoint: Baseline to Week 12;Percentage change from baseline in primary uterine fibroid volumeTimepoint: Baseline to Week 12 | — |
Countries
India
Contacts
Public ContactBadrinath Sangle
Vivotech Research Private Limited
Outcome results
None listed