A Study to Assess the Effectiveness and Safety of Different Doses of ASP1707 Compared to Placebo for Endometriosis Associated Pelvic Pain
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
2 other identifiers
interventional
912
9 countries
85
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2012
85 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 4, 2012
CompletedFirst Submitted
Initial submission to the registry
December 18, 2012
CompletedFirst Posted
Study publicly available on registry
January 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 13, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2015
CompletedOctober 23, 2024
October 1, 2024
2.4 years
December 18, 2012
October 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (16)
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 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
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
- +11 more secondary outcomes
Study Arms (6)
Placebo
PLACEBO COMPARATORApplicable 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 lowest dose
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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 high dose
EXPERIMENTALSubjects 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
ACTIVE COMPARATORSubjects in this arm will be treated with leuprorelin acetate for a total of 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Pre menopausal female adults with confirmed length and regular menstrual cycle
- Surgically diagnosed endometriosis
- Moderate to severe endometriosis related pain
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (85)
Site: 1006
Brussels, 1200, Belgium
Site: 1002
Genk, 3600, Belgium
Site: 1003
Ghent, 9000, Belgium
Site: 1001
Leuven, 3000, Belgium
Site: 1005
Liège, 4000, Belgium
Site: 1105
Plovdiv, Bulgaria
Site: 1104
Sofia, 1000, Bulgaria
Site: 1107
Sofia, 1330, Bulgaria
Site: 1106
Sofia, 1504, Bulgaria
Site: 1102
Sofia, Bulgaria
Site: 1103
Stara Zagora, 6000, Bulgaria
Site: 1390
Berlin, Germany
Site: 1304
Dresden, Germany
Site: 1302
Erlangen, Germany
Site: 1311
Karlsruhe, Germany
Site: 1306
Lübeck, Germany
Site: 1422
Kecskemét, Bacs-Kiskun Megye, 6000, Hungary
Site: 1401
Budapest, 1135, Hungary
Site: 1407
Budapest, Hungary
Site: 1408
Debrecen, 4012, Hungary
Site: 1406
Pécs, Hungary
Site: 1403
Szekszárd, 7100, Hungary
Site: 1402
Székesfehérvár, Hungary
Site: 2018
Aomori, 036 8203, Japan
Site: 2017
Chiba, 299 0111, Japan
Site: 2005
Fujisawa, 252 0804, Japan
Site: 2034
Hyōgo, 666 0195, Japan
Site: 2039
Hyōgo, Japan
Site: 2040
Hyōgo, Japan
Site: 2032
Kagoshima, Japan
Site: 2015
Kanagawa, 213 8507, Japan
Site: 2035
Kanagawa, Japan
Site: 2013
Kawagoe, 350-8550, Japan
Site: 2029
Kawasaki, 210 0024, Japan
Site: 2024
Kawasaki, 212 0058, Japan
Site: 2033
Kochi, 783 8505, Japan
Site: 2031
Kumamoto, 861 8520, Japan
Site: 2010
Kurashiki, 710 0824, Japan
Site: 2006
Kyoto, 602 8566, Japan
Site: 2036
Nagano, Japan
Site: 2037
Nagano, Japan
Site: 2038
Nagano, Japan
Site: 2002
Nagaoka, 940 2085, Japan
Site: 2007
Nagasaki, 850 0003, Japan
Site: 2011
Nara, 631 0805, Japan
Site: 2027
Sapporo, 060 0001, Japan
Site: 2001
Sapporo, 060 0031, Japan
Site: 2030
Sapporo, 060 0061, Japan
Site: 2004
Tokyo, 101 0062, Japan
Site: 2020
Tokyo, 107 0052, Japan
Site: 2014
Tokyo, 113 8431, Japan
Site: 2009
Tokyo, 113 8603, Japan
Site: 2003
Tokyo, 1130033, Japan
Site: 2028
Tokyo, 141 0022, Japan
Site: 2025
Tokyo, 157 0061, Japan
Site: 2016
Tokyo, Japan
Site: 2012
Yokohama, 225 0024, Japan
Site: 1501
Bialystok, 15-464, Poland
Site: 1505
Bialystok, Poland
Site: 1512
Gdansk, Poland
Site: 1504
Katowice, 40-724, Poland
Site: 1508
Lublin, 20-333, Poland
Site: 1507
Lublin, 20-632, Poland
Site: 1502
Warsaw, 02-066, Poland
Site: 1509
Warsaw, Poland
Site: 1525
Warzawa, Poland
Site: 1604
Brasov, Romania
Site: 1607
Bucaresti, Romania
Site: 1602
Bucharest, 11475, Romania
Site: 1601
Bucharest, Romania
Site: 1606
Bucharest, Romania
Site: 1603
Târgu Mureş, Romania
Site: 1701
Bucuresti, Ukraine
Site: 1702
Bucuresti, Ukraine
Site: 1705
Bucuresti, Ukraine
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: 1807
London, SE5 9RS, United Kingdom
Site: 1804
Norwich, NR47UY, United Kingdom
Site: 1808
Sheffield, S10 2SF, United Kingdom
Site: 1806
Southampton, SO16 5YA, United Kingdom
Related Publications (1)
D'Hooghe T, Fukaya T, Osuga Y, Besuyen R, Lopez B, Holtkamp GM, Miyazaki K, Skillern L. Efficacy and safety of ASP1707 for endometriosis-associated pelvic pain: the phase II randomized controlled TERRA study. Hum Reprod. 2019 May 1;34(5):813-823. doi: 10.1093/humrep/dez028.
PMID: 31067329DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clinical Study Manager
Astellas Pharma Europe B.V.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2012
First Posted
January 14, 2013
Study Start
December 4, 2012
Primary Completion
May 13, 2015
Study Completion
July 30, 2015
Last Updated
October 23, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.