Health Condition 1: N948- Other specified conditions associated with female genital organs and menstrual cycle
Conditions
Interventions
Intervention1: Elagolix tablets: Patients will receive Elagolix tablet 150 mg orally, in morning along with matching placebo of Dienogest 2 mg tablet orally for 24 weeks
Control Intervention1: Dienoge
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Premenopausal female between 18 and 49 years of age, inclusive, at the time of signing consent. 3. Patient has diagnosis of endometriosis established by means of documented surgical visualization or USG 4. Patient has moderate to severe pain associated with endometriosis (both DYS as well as NMPP) score at screening and randomization. 5. Patient has NRS score of 4 and above at screening & randomization. 6. Patient must agree to use rescue medication, only those permitted by the protocol during the study. 7. Patient must have had two normal menstrual cycles immediately prior to Screening. 8. Agree to use two forms of non-hormonal contraception 9. Patients must have a negative serum pregnancy test
Exclusion criteria
Exclusion criteria: 1. Concomitant dyspareunia, previous history of a severe, life threatening or other significant sensitivity to any drug 2. Patient is pregnant or breast feeding or is planning a pregnancy within the next 4 months; or less than 6 months postpartum, post abortion, or post pregnancy at the time of entry into the Screening Period. 3. Patient has a history of drug and or alcohol abuse. 4. Patient has a positive history of HIV, HBV or HCV. 5. Patient has clinically significant abnormalities in ECG, hematology, biochemistry or urinalysis, including, but not limited to AST or ALT or bilirubin (unless known diagnosis of Gilberts syndrome) greater than or equal to 1.5 times the upper limit of the reference range or Serum creatinine greater than 1.5 mg per dL at screening. 6. Patient has used any known inducers of CYP 3A 7. Patient has clinically significant abnormalities in ECG, hematology, biochemistry or urinalysis 8. Patient has a history of major depression OR other major psychiatric disorder 9. Patient has a surgical history of hysterectomy, bilateral oophorectomy, surgical procedure that interferes with gastrointestinal motility, pH, or absorption, any major surgery within 6 months OR any minor surgery within 3 months prior to Day 1, or is scheduled for a surgical procedure during the course of the study. 10. Patient has a history of previous non-response to GnRH agonists, GnRH antagonists, DMPA, or aromatase inhibitors 11. Patient has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, which would interfere with the assessment of endometriosis related pain. 12. Clinically significant gynecologic condition 13. Patient has a current history of undiagnosed abnormal genital bleeding 14. Patient has a history of osteoporosis or other metabolic bone disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline to Day 85 in NRS ScoreTimepoint: baseline to Day 85 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in BMD measured by DEXATimepoint: Till end of study;Mean change from baseline to Day 169 in NRS scoreTimepoint: baseline to Day 169;Mean change from baseline to Day 85 and Day 169 in DYS scoreTimepoint: baseline to Day 85 and Day 169;Mean change from baseline to Day 85 and Day 169 in NMPP scoreTimepoint: baseline to Day 85 and Day 169;Number and percentage of patients who responded â??much improvedâ?? or â??very much improvedâ?? for the Patient Global Impression of ChangeTimepoint: Day 85 and Day 169;Proportion of patients requiring rescue medicationTimepoint: Till end of study;Proportion of patients with AEs and SAEsTimepoint: Till end of study;Total consumption of rescue medication (as per 250 mg naproxen tablet) after randomizationTimepoint: Till end of study | — |
Countries
India
Contacts
Public ContactRajesh Gaikwad
Sun Pharma Laboratories Limited
Outcome results
None listed