Efficacy and Safety of Elagolix in Comparison Dienogest for Treatment of Moderate to Severe Pain Associated with Endometriosis (tissue similar to that lining the uterus grows outside uterine cavity)
- Conditions
- Health Condition 1: N948- Other specified conditions associated with female genital organs and menstrual cycle
- Registration Number
- CTRI/2023/01/049292
- Lead Sponsor
- Sun Pharma Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method