Health Condition 1: N809- Endometriosis, unspecified Health Condition 2: R102- Pelvic and perineal pain Health Condition 3: N941- Dyspareunia
Conditions
Interventions
Intervention1: Tablet Evagolix 150 mg for dysmenorrhea and non-menstrual pelvic pain
Or
Tablet Evagolix 200 mg for dyspareunia
: orally once a day for 84 days
Intervention2: Nil: Nil
Control Inter
Sponsors
Corona Remedies Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Patients will be included if they meet the following criteria: 1. Female subjects aged between 18 and 49 years (both ages inclusive). 2. Non-pregnant, non-lactating female patients. 3. Patient who has given consent for the study 4. Patient who has been diagnosed to suffer from • Dysmenorrhea due to endometriosis • Non-menstrual pelvic pain due to endometriosis • Dyspareunia due to endometriosis 5. Patients willing to follow-up at scheduled visit as per protocol at same centre 6. Female who agrees to use required birth control methods during the entire length of participation in the study. 7. Female must have at least two regular menstrual cycles with an interval of 24-38 days within the Screening visit, prior to Day 1.
Exclusion criteria
Exclusion criteria: Patients will be excluded if they have any of the following: 1. Patients with known hypersensitivity or severe allergic reactions to study drug or any of the excipients 2. Using other drugs for endometriosis treatment 3. Pregnant and lactating women 4. Patient with known osteoporosis 5. Patient with severe hepatic impairment 6. Patient with concomitant use of cyclosporine or gemfibrozil. 7. Patient is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Dysmenorrhea severity using Numeric Rating Scale (NRS) Change in non-menstrual pelvic pain using Numeric Rating Scale (NRS) Change in Dyspareunia using Numeric Rating Scale (NRS) Timepoint: Baseline visit Day 0, Week 4 and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Use of rescue analgesics Improvement in Health-related Quality of Life (HrQoL) Incidence of adverse event Timepoint: Baseline Day 0, Week 4 and Week 12 | — |
Countries
India
Contacts
Public ContactKalpana Sharma
Zyfis Lifesciences Private Limited
Outcome results
None listed