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 provide a written informed consent specific to this study prior to starting the extension study treatment. 2. The subject has completed the 6-month treatment in the main study. 3. The subject is willing and able to continue to comply with the requirements of the study protocol for the duration of the extension study. 4. The subject must agree to continue to use only the analgesic rescue medication permitted by the protocol during the Treatment and Follow-up Periods. 5. If of childbearing potential, the subject agrees to continue to use one of the permitted by the protocol birth control methods during the entire Treatment Period of the study and until 3 months after the end of treatment. 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 288 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 is planning a pregnancy within the duration of the study (including the Follow-up Period). 2. The subject is likely to require treatment during the study with any of the medications prohibited by the protocol. 3. The subject is likely to use cannabinoids during the study. 4. The subject has any other clinically significant gynecologic condition identified on TVUS or endometrial biopsy or at the manual breast examination during the main study, which might interfere with the study efficacy and safety objectives. 5. The subject has met any of the main study discontinuation criteria. a. Serum calcium level confirmed on a repeat fasting test above 2.9 mmol/ L. 6.The subject has any condition that, in the opinion of the Investigator, constitutes a risk or a contraindication to the participation of the subject in this extension study or that could interfere with the study objectives, conduct or assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the maintenance of efficacy of linzagolix administered orally once daily for up to an additional 6 months (for up to 12 months of treatment in total) in women who have already completed 6 months of linzagolix treatment at a dose of 75 mg alone or of 200 mg in combination with add-back therapy , in the management of moderate to severe EAP in women with surgically confirmed endometriosis. ;Secondary Objective: Efficacy objectives: Secondary objectives include evaluation of efficacy over the last 28 days of randomized treatment up to the Month 12 visit based on the following parameters: 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, composite, efficacy endpoints are clinically meaningful reduction from baseline to the last 28 days preceding the Month 12 visit (the 4-week period preceding Month 12 visit) along with a stable or decreased use of analgesics for EAP in the mean daily assessment of 1) DYS and of 2) NMPP, both measured on a Verbal Rating Scale (VRS) using an electronic diary (eDiary). ;Timepoint(s) of evaluation of this end point: Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: • Change from baseline to Month 12 in DYS (VRS) • Change from baseline to Month 12 in NMPP (VRS) • Change from baseline to Month 12 in dyschezia (Numeric Rating Scale - NRS) • Change from baseline to Month 12 in overall pelvic pain (NRS) • Change from baseline to Month 12 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 12 in dyspareunia (VRS) • No analgesics use for EAP during the preceding 4-week period at each scheduled assessment • No opiate use for EAP during the preceding 4-week period at each scheduled assessment Safety endpoints: • Change from baseline to each scheduled assessment in BMD measured by DXA of lumbar spine (L1-L4), 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: throughout the study up to Month 12 Safety endpoints: throughout the study | — |
Countries
Austria, Bulgaria, Czechia, Czech Republic, France, Hungary, Poland, Romania, Spain, Ukraine, United States
Contacts
Public ContactClinical Trial Information
ObsEva SA
Outcome results
None listed