A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Assess the Efficacy, Safety, and Dose-Response Relationship of ASP1707 in Subjects With Endometriosis Associated Pelvic Pain for 12 Weeks, Followed by a 12-Week Double-blind Extension Without Placebo Control, Including a 24-Week Open-Label Leuprorelin Acetate Treatment Group for Bone Mineral Density Assessment
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Endometriosis
- Sponsor
- Astellas Pharma Europe B.V.
- Enrollment
- 912
- Locations
- 85
- Primary Endpoint
- Change from baseline to the end of 12 weeks treatment of pain score for dysmenorrhea
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The main objective for this study is to assess the efficacy and dose-response relationship of ASP1707 in reduction of endometriosis associated pelvic pain. The secondary objectives are to assess the safety, tolerability, Pharmacokinetics of ASP1707, dose response relationship of ASP1707 in reduction of E2 (Estradiol), 24-week efficacy of ASP1707 in reduction of endometriosis associated pain and 24-week safety and tolerability of ASP1707.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pre menopausal female adults with confirmed length and regular menstrual cycle
- •Surgically diagnosed endometriosis
- •Moderate to severe endometriosis related pain
Exclusion Criteria
- •Hormonal contraceptives or other drugs with effects on gynecological endocrinology
- •Surgery for endometriosis within the 4 weeks prior to entry
- •Uterine myoma
- •Abnormal vaginal bleeding
- •Hysterectomy or bilateral oophorectomy
- •Pelvic infection
- •Relevant abnormalities at gynecological exam at screening
- •Disease with chronic abdominal pain of non-endometriosis origin
- •Pituitary adenoma
Arms & Interventions
Placebo
Applicable to first 12 week period (Part One); subjects in this arm will be randomized to one of the ASP1707 dose levels for the second 12 week period (Part Two)
Intervention: Placebo
ASP1707 lowest dose
Subjects in this arm will be dosed with ASP1707 once daily for a total of 12 weeks (Part One) and continue taking the assigned dose for a further 12 weeks during the extension phase of the study (Part Two) for a total of 24 weeks
Intervention: ASP1707
ASP1707 low dose
Subjects in this arm will be dosed with ASP1707 once daily for a total of 12 weeks (Part One) and continue taking the assigned dose for a further 12 weeks during the extension phase of the study (Part Two) for a total of 24 weeks
Intervention: ASP1707
ASP1707 medium dose
Subjects in this arm will be dosed with ASP1707 once daily for a total of 12 weeks (Part One) and continue taking the assigned dose for a further 12 weeks during the extension phase of the study (Part Two) for a total of 24 weeks
Intervention: ASP1707
ASP1707 high dose
Subjects in this arm will be dosed with ASP1707 once daily for a total of 12 weeks (Part One) and continue taking the assigned dose for a further 12 weeks during the extension phase of the study (Part Two) for a total of 24 weeks
Intervention: ASP1707
Leuprorelin acetate
Subjects in this arm will be treated with leuprorelin acetate for a total of 24 weeks
Intervention: Leuprorelin acetate
Outcomes
Primary Outcomes
Change from baseline to the end of 12 weeks treatment of pain score for dysmenorrhea
Time Frame: Baseline & Week 12
Change from baseline to the end of 12 weeks treatment of pain score for overall pelvic pain
Time Frame: Baseline & Week 12
Change from baseline to the end of 12 weeks treatment of pain score for non-menstrual pelvic pain
Time Frame: Baseline & Week 12
Secondary Outcomes
- Pharmacodynamic profile of ASP1707 measured by Serum Estradiol (E2) levels(Up to Week 26)
- Change from baseline to the end of 24 weeks treatment of pain score for overall pelvic pain(Baseline & Week 24)
- Change from baseline to the end of 24 weeks treatment of pain score for non-menstrual pelvic pain(Baseline & Week 24)
- Change from baseline to the end of treatment (EoT) of the dyspareunia score(Baseline, Week 12 & Week 24)
- Occurrence of response at the EoT for pain score for overall pelvic pain, dysmenorrhea, non-menstrual pelvic pain and dyspareunia(Week 12 & Week 24)
- Change from baseline to the EoT of the mean Pain Interference score of the Brief Pain Inventory(Baseline, Week 12 & Week 24)
- Change from baseline to the EoT in the Endometriosis Health Profile (EHP)-5 score(Baseline, Week 12 & Week 24)
- Change from baseline to the EoT of the Beck's Depression Inventory (BDI)-II score(Baseline, Week 12 & Week 24)
- Patient Global Impression of Change (PGIC) at the End of Treatment(Week 12 & Week 24)
- Change from baseline to the EoT of the mean scores of the modified Biberoglu and Behrman (B&B) symptom and sign domains(Baseline, Week 12 & Week 24)
- Change from baseline to the EoT of the Female Sexual Function Index (FSFI) score (sexual well-being)(Baseline, Week 12 & Week 24)
- Change from baseline to the EoT in the EuroQol (EQ-5D-5L) score(Baseline, Week 12 & Week 24)
- Safety and tolerability of ASP1707 measured by Adverse Events (AEs), bleeding patterns, Bone Mineral Density (BMD)(Up to Week 42)
- Change from baseline to the end of 24 weeks treatment of pain score for dysmenorrhea(Baseline & Week 24)
- Change from baseline to the EoT of the use of protocol defined rescue medication(Baseline, Week 12 & Week 24)
- Pharmacokinetic profile of ASP1707(Up to Week 24)