Endometriosis-associated pain MedDRA version: 20.0 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Sponsors
ObsEva S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject must have had her most recent surgical and – if available – histological diagnosis of pelvic endometriosis (laparoscopy, laparotomy, vaginal fornix or other biopsy) up to 10 years before screening. 2. The subject has moderate to severe endometriosis- associated pain during the screening period. 3. The subject has regular menstrual cycles. 4. The subject has a Body BMI = 18 kg/m2 at the screening visit. 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 450 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The subject is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study. 2. The subject is less than 6 months postpartum or 3 months post-abortion/miscarriage at the time of entry into the screening period. 3. The subject has a surgical history of any major abdominal surgery within 6 months or any interventional surgery for endometriosis performed within a period of 2 months before screening. 4. The subject did not respond to prior treatment with GnRH agonists or GnRH antagonists for endometriosis. 5. The subject has a history of, or known, osteoporosis or other metabolic bone disease. 6. The subject has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic or other chronic therapy which would interfere with the assessment of endometriosis-associated pain.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back therapy versus placebo, in the management of moderate to severe endometriosis-associated pain. ;Secondary Objective: Efficacy objectives: Secondary objectives include evaluation of persistence of efficacy at 6 months, evaluation of pain associated with sexual intercourse (dyspareunia) and defecation (dyschezia), difficulty of doing daily activities, analgesic use, assessment of subject perception of severity, change in uterine bleeding, Quality of Life (QoL) questionnaires, pharmacoeconomic burden of endometriosis by assessing changes in patient productivity, assessment of endometriosis related number of non-study health visits, number of days in hospital and type of medical procedures performed during the Treatment Period. Safety and tolerability objectives include assessment of BMD, endometrial health, cardiac safety including QT interval prolongation, standard laboratory safety parameters, gynecological assessments and AE frequency including specific hypoestrogenic AEs.;Primary end point(s): The two co-primary efficacy endpoints are clinically meaningful reduction at Month 3 (the 4-week period preceding Month 3) from baseline in the mean daily assessment of DYS and of NMPP measured on a Verbal Rating Scale (VRS) using an electronic diary (eDiary), along with a stable or decreased use of analgesics for endometriosis-associated pain.;Timepoint(s) of evaluation of this end point: Month 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Ranked secondary efficacy endpoints: - Change from baseline to Month 6 in DYS (VRS) - Change from baseline to Month 6 in NMPP (VRS) - Change from baseline to Month 6 in dyschezia (NRS) - Change from baseline to Month 6 in overall pelvic pain (NRS) - Change from baseline to Month 6 in the interference of pain with the ability to perform daily activities, measured using the pain dimension of the EHP-30 - Change from baseline to Month 6 in dyspareunia (VRS) - No analgesics use for EAP during the preceeding 4-week period at Month 6 - No opiate use for EAP during the preceeding 4-week period at Month 6 Safety endpoints: - Change from baseline to each scheduled assessment in BMD measured by DXA of lumbar spine, femoral neck, and total hip - Incidence and severity of TEAEs - Incidence and severity of hypoestrogenic TEAEs (hot flush) - Time to the first post-treatment menses - Changes in clinical laboratory assessments from baseline to each scheduled assessment - Any pathological changes from baseline in the endometrium as assessed by histology from endometrial biopsies - Changes from baseline to each scheduled assessment in any other safety parameter ;Timepoint(s) of evaluation of this end point: Efficacy endpoints: Month 6 Safety endpoints: throughout the study | — |
Countries
Austria, Bulgaria, Czech Republic, France, Hungary, Poland, Romania, Spain, Ukraine, United States
Contacts
Public ContactClinical Trial Information
ObsEva SA
Outcome results
None listed