Health Condition 1: N948- Other specified conditions associated with female genital organs and menstrual cycle
Conditions
Interventions
Intervention1: Relugolix + Estradiol + Norethindrone Acetate (40 mg + 1 mg + 0.5 mg) Tablets: Patients will receive FDC of Relugolix + Estradiol + Norethindrone Acetate (NETA) (40 mg + 1 mg + 0.5 mg)
Sponsors
Sun Pharmaceutical Industries Limited (SPIL)
Sun Pharmaceutical Industries Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient willing to provide written informed consent 2. Premenopausal female of age 18 – 50 years and BMI of 18 – 30 kg/m2 3. Regular menstrual periods of duration of 3 to 14 days and a cycle interval of 21 to 35 days (from the start of one menstrual period until the start of the next) for at least 3 months prior to Screening 4. Confirmed diagnosis of uterine fibroids that is supported by a documented evidence (either previous or at Screening) of ultrasound/CT abdomen/MRI abdomen and have not received any surgical treatment for uterine fibroid 5. Heavy menstrual bleeding associated with uterine fibroids 6. Women of childbearing potential must have a negative urine pregnancy test at Screening and at Randomization visit and not intend to become pregnant and agree to use 2 forms of non-hormonal contraceptive during the study
Exclusion criteria
Exclusion criteria: 1. Patients with ultrasound (at screening) demonstrating pathology other than uterine fibroids that could be responsible for or contributing to the patients heavy menstrual bleeding 2. Patient has a rapidly enlarging uterine fibroid as per Investigator’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 Investigator’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: Baseline to 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients to achieve a 50 percentage reduction of PBAC score from BaselineTimepoint: Baseline, 12 weeks;Percentage change from baseline in primary uterine fibroid volumeTimepoint: Baseline, 12 weeks;Proportion of patients with AEsTimepoint: Screening to Week 16;Percentage of patients experiencing vasomotor symptomsTimepoint: up to 12 weeks | — |
Countries
India
Contacts
Public ContactDigambar Tornale
Sun Pharma Laboratories Limited
Outcome results
None listed