Treatment of Endometriosis-Associated Pain MedDRA version: 20.0 Level: SOC Classification code 10038604 Term: Reproductive system and breast disorders System Organ Class: 10038604 - Reproductive system and breast disorders MedDRA version: 20.0 Level: LLT Classification code 10014788 Term: Endometriosis related pain System Organ Class: 10038604 - Reproductive system and breast disorders MedDRA version: 20.0 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604
Conditions
Sponsors
ObsEva SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: MAIN STUDY: • The subject must have had her most recent surgical and - if available - histological, diagnosis of pelvic endometriosis up to 10 years before screening. • The subject has moderate to severe endometriosis-associated pain during the screening period. • The subject has regular menstrual cycles. • The subject has a BMI = 18 kg/m2 at the screening visit. EXTENSION PHASE: • The subject must have completed Parts A and B (24 weeks) treatment period in the main study. • The subject is willing and able to continue to comply with the requirements of the study protocol for the duration of the extension. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 330 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: MAIN STUDY: • The subject is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study. • The subject had an interventional surgery for endometriosis performed within a period of 60 days before screening. • The subject did not respond to prior treatment with gonadotropin releasing hormone (GnRH) agonists or GnRH antagonists for endometriosis. • The subject has a history of, or known osteoporosis or other metabolic bone disease. • The subject has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic / therapy, or that would interfere with the assessment of endometriosis related pain. EXTENSION PHASE: • The subject is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the extension. • The subject has at least one ovarian endometrioma with a diameter of 7 cm or greater. • The subject has BMD loss > 7% at either femoral neck, hip or spine or a Z-score = -2.5 on the Week 24 DXA Scan during the main study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Thirty percent or greater reduction from baseline to week 12 in the mean overall pelvic pain score ;Timepoint(s) of evaluation of this end point: Week 12 ;Main Objective: To assess the efficacy of a range of oral doses of OBE2109 versus placebo, in reducing pelvic pain in subjects with moderate to severe endometriosis pain. To assess the safety and tolerability of OBE2109 in subjects with endometriosis.;Secondary Objective: To assess the efficacy of a range of oral doses of OBE2109 vs placebo in: • Reducing pelvic pain on days with uterine bleeding and pelvic pain on days with no uterine bleeding • Reducing pain associated with sexual intercourse (dyspareunia) • Reducing pain associated with defecation (dyschezia) • Reducing difficulty in performing daily activities • Reducing subject reported pain symptoms of endometriosis (dysmenorrhea, pelvic pain and dyspareunia) and physician assessed objective findings of endometriosis (pelvic tenderness and pelvic induration) according to the modified Biberoglu & Behrman (mB&B) scale • Reducing the use of analgesic medication to treat pelvic pain • Reducing incidence and intensity of uterine bleeding • Improving quality of life and subject perception of change and severity PK-PD objectives: To assess OBE2109 PK and establish the possible relationship between OBE2109 exposure and pain, estradiol level, luteinizing hormone level and bone mineral density. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Thirty percent or greater reduction from baseline assesed on a VRS for pelvic pain. 2. Thirty percent or greater reduction from baseline assessed on a Numerical Rating Scale (NRS). 3. Thirty percent or greater reduction from baseline in the mean pelvic pain score for days with uterine bleeding/spotting and for days with no uterine bleeding . 4. The mean pelvic pain score for days with uterine bleeding/spotting, for days with no uterine bleeding and all days during the preceding 4-week period. 5. The mean highest pelvic pain score. 6. The incidence of amenorrhea. 7. The number of days with uterine bleeding. 8. The mean of daily dyspareunia scores. 9. The monthly dyschezia pain score. 10. The use of analgesics. 11. The number of days of analgesic use. 12. The number of days with pelvic pain. 13. The number of days with moderate to severe pelvic pain. 14. The mean of scores for difficulty in performing daily activity. 15. The severity of subject assessed symptoms and physician assessed objective findings according to the mB&B scale. 16. The Endometriosis Health Profile-30 (EHP-30) score. 17. The Patient Global Impression of Change (PGIC) score. 18. The patient’s impression of severity. 19. Time to recommencement of menstruation from the time of stopping dosing.;Timepoint(s) of evaluation of this end point: 1. weeks 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64 2.-14. weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64 15. -17. weeks 12, 24, 36, 38, 52 and 64 18. weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64 | — |
Countries
Poland, Russian Federation, Ukraine, United States
Contacts
Public ContactClinical Trials Information
ObsEva SA
Outcome results
None listed