A Study to Assess the Effectiveness and Safety of Different Doses of ASP1707 Compared to Placebo for Endometriosis Associated Pelvic Pain
- Conditions
- Endometriosis
- Interventions
- Registration Number
- NCT01767090
- Lead Sponsor
- Astellas Pharma Europe B.V.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 912
- Pre menopausal female adults with confirmed length and regular menstrual cycle
- Surgically diagnosed endometriosis
- Moderate to severe endometriosis related pain
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASP1707 lowest dose ASP1707 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 ASP1707 medium dose ASP1707 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 Placebo 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) ASP1707 high dose ASP1707 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 ASP1707 low dose ASP1707 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 Leuprorelin acetate Leuprorelin acetate Subjects in this arm will be treated with leuprorelin acetate for a total of 24 weeks
- Primary Outcome Measures
Name Time Method 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 overall pelvic pain 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 Outcome Measures
Name Time Method 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 Both CL/F, V/F, AUCtau, Cmax, Ctrough
Trial Locations
- Locations (85)
Site: 1505
🇵🇱Bialystok, Poland
Site: 1508
🇵🇱Lublin, Poland
Site: 1509
🇵🇱Warsaw, Poland
Site: 1606
🇷🇴Bucuresti, Romania
Site: 1106
🇧🇬Sofia, Bulgaria
Site: 1408
ðŸ‡ðŸ‡ºDebrecen, Hungary
Site: 2007
🇯🇵Nagasaki, Japan
Site: 2009
🇯🇵Tokyo, Japan
Site: 2012
🇯🇵Yokohama, Japan
Site: 2032
🇯🇵Kagoshima, Japan
Site: 2015
🇯🇵Kanagawa, Japan
Site: 2038
🇯🇵Nagano, Japan
Site: 2011
🇯🇵Nara, Japan
Site: 2028
🇯🇵Tokyo, Japan
Site: 2025
🇯🇵Tokyo, Japan
Site: 2003
🇯🇵Tokyo, Japan
Site: 1501
🇵🇱Bialystok, Poland
Site: 1507
🇵🇱Lublin, Poland
Site: 1601
🇷🇴Bucuresti, Romania
Site: 1502
🇵🇱Warszawa, Poland
Site: 1525
🇵🇱Warzawa, Poland
Site: 1705
🇺🇦Bucuresti, Ukraine
Site: 1603
🇷🇴Targu Mures, Romania
Site: 1707
🇺🇦Bucuresti, Ukraine
Site: 1713
🇺🇦Donetsk, Ukraine
Site: 1716
🇺🇦Donetsk, Ukraine
Site: 1708
🇺🇦Kyiv, Ukraine
Site: 1703
🇺🇦Targu Mures, Ukraine
Site: 1717
🇺🇦Zaporizhzhya, Ukraine
Site: 2027
🇯🇵Sapporo, Japan
Site: 2014
🇯🇵Tokyo, Japan
Site: 2037
🇯🇵Nagano, Japan
Site: 2002
🇯🇵Nagaoka, Japan
Site: 2020
🇯🇵Tokyo, Japan
Site: 2036
🇯🇵Nagano, Japan
Site: 1512
🇵🇱Gdansk, Poland
Site: 1504
🇵🇱Katowice, Poland
Site: 2001
🇯🇵Sapporo, Japan
Site: 2030
🇯🇵Sapporo, Japan
Site: 2004
🇯🇵Tokyo, Japan
Site: 2016
🇯🇵Tokyo, Japan
Site: 1804
🇬🇧Norwich, United Kingdom
Site: 1607
🇷🇴Bucaresti, Romania
Site: 1807
🇬🇧London, United Kingdom
Site: 1604
🇷🇴Brasov, Romania
Site: 1602
🇷🇴Bucharest, Romania
Site: 1701
🇺🇦Bucuresti, Ukraine
Site: 1702
🇺🇦Bucuresti, Ukraine
Site: 1806
🇬🇧Southampton, United Kingdom
Site: 1006
🇧🇪Bruxelles, Belgium
Site: 1003
🇧🇪Gent, Belgium
Site: 1001
🇧🇪Leuven, Belgium
Site: 1002
🇧🇪Genk, Belgium
Site: 1005
🇧🇪Liege, Belgium
Site: 1104
🇧🇬Sofia, Bulgaria
Site: 1107
🇧🇬Sofia, Bulgaria
Site: 1105
🇧🇬Plovdiv, Bulgaria
Site: 1102
🇧🇬Sofia, Bulgaria
Site: 1103
🇧🇬Stara Zagora, Bulgaria
Site: 1302
🇩🇪Erlangen, Germany
Site: 1390
🇩🇪Berlin, Germany
Site: 1304
🇩🇪Dresden, Germany
Site: 1311
🇩🇪Karlsruhe, Germany
Site: 1422
ðŸ‡ðŸ‡ºKecskemet, Bacs-Kiskun Megye, Hungary
Site: 1306
🇩🇪Luebeck, Germany
Site: 1401
ðŸ‡ðŸ‡ºBudapest, Hungary
Site: 1407
ðŸ‡ðŸ‡ºBudapest, Hungary
Site: 1406
ðŸ‡ðŸ‡ºPecs, Hungary
Site: 1402
ðŸ‡ðŸ‡ºSzekesfehervar, Hungary
Site: 1403
ðŸ‡ðŸ‡ºSzekszard, Hungary
Site: 2017
🇯🇵Chiba, Japan
Site: 2018
🇯🇵Aomori, Japan
Site: 2005
🇯🇵Fujisawa, Japan
Site: 2034
🇯🇵Hyogo, Japan
Site: 2039
🇯🇵Hyogo, Japan
Site: 2040
🇯🇵Hyogo, Japan
Site: 2035
🇯🇵Kanagawa, Japan
Site: 2013
🇯🇵Kawagoe, Japan
Site: 2029
🇯🇵Kawasaki, Japan
Site: 2024
🇯🇵Kawasaki, Japan
Site: 2033
🇯🇵Kochi, Japan
Site: 2031
🇯🇵Kumamoto, Japan
Site: 2006
🇯🇵Kyoto, Japan
Site: 2010
🇯🇵Kurashiki, Japan
Site: 1808
🇬🇧Sheffield, United Kingdom