Endometriosis
Conditions
Keywords
Phase 2, Double-blind, Pelvic pain, ASP1707, Placebo-controlled, Endometriosis
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.
Interventions
Sponsors
Astellas Pharma Europe B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of 12 weeks treatment of pain score for overall pelvic pain | Baseline & Week 12 |
| Change from baseline to the end of 12 weeks treatment of pain score for dysmenorrhea | Baseline & Week 12 |
| Change from baseline to the end of 12 weeks treatment of pain score for non-menstrual pelvic pain | Baseline & Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 use of protocol defined rescue medication | Baseline, 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 | — |
| Patient Global Impression of Change (PGIC) at the End of Treatment | Week 12 & Week 24 | — |
| 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 EoT of the Female Sexual Function Index (FSFI) score (sexual well-being) | 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 | — |
| 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 | — |
| Pharmacodynamic profile of ASP1707 measured by Serum Estradiol (E2) levels | Up to Week 26 | — |
| Pharmacokinetic profile of ASP1707 | Up to Week 24 | Both CL/F, V/F, AUCtau, Cmax, Ctrough |
| Change from baseline to the EoT in the Endometriosis Health Profile (EHP)-5 score | Baseline, Week 12 & Week 24 | — |
| Change from baseline to the end of 24 weeks treatment of pain score for dysmenorrhea | Baseline & Week 24 | — |
| Change from baseline to the end of 24 weeks treatment of pain score for non-menstrual pelvic pain | Baseline & Week 24 | — |
Countries
Belgium, Bulgaria, Germany, Hungary, Japan, Poland, Romania, Ukraine, United Kingdom
Outcome results
None listed