A Study to Assess the Effectiveness and Safety of Different Doses of ASP1707 Compared to Placebo for Endometriosis Associated Pelvic Pain
NCT ID: NCT01767090
Last Updated: 2024-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
912 participants
INTERVENTIONAL
2012-12-04
2015-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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)
Placebo
Oral
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
ASP1707
Oral
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
ASP1707
Oral
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
ASP1707
Oral
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
ASP1707
Oral
Leuprorelin acetate
Subjects in this arm will be treated with leuprorelin acetate for a total of 24 weeks
Leuprorelin acetate
subcutaneous
Interventions
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ASP1707
Oral
Placebo
Oral
Leuprorelin acetate
subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Surgically diagnosed endometriosis
* Moderate to severe endometriosis related pain
Exclusion Criteria
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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Astellas Pharma Europe B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Study Manager
Role: STUDY_CHAIR
Astellas Pharma Europe B.V.
Locations
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Site: 1006
Brussels, , Belgium
Site: 1002
Genk, , Belgium
Site: 1003
Ghent, , Belgium
Site: 1001
Leuven, , Belgium
Site: 1005
Liège, , Belgium
Site: 1105
Plovdiv, , Bulgaria
Site: 1104
Sofia, , Bulgaria
Site: 1107
Sofia, , Bulgaria
Site: 1106
Sofia, , Bulgaria
Site: 1102
Sofia, , Bulgaria
Site: 1103
Stara Zagora, , 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, Hungary
Site: 1401
Budapest, , Hungary
Site: 1407
Budapest, , Hungary
Site: 1408
Debrecen, , Hungary
Site: 1406
Pécs, , Hungary
Site: 1403
Szekszárd, , Hungary
Site: 1402
Székesfehérvár, , Hungary
Site: 2018
Aomori, , Japan
Site: 2017
Chiba, , Japan
Site: 2005
Fujisawa, , Japan
Site: 2034
Hyōgo, , Japan
Site: 2039
Hyōgo, , Japan
Site: 2040
Hyōgo, , Japan
Site: 2032
Kagoshima, , Japan
Site: 2015
Kanagawa, , 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: 2010
Kurashiki, , Japan
Site: 2006
Kyoto, , Japan
Site: 2036
Nagano, , Japan
Site: 2037
Nagano, , Japan
Site: 2038
Nagano, , Japan
Site: 2002
Nagaoka, , Japan
Site: 2007
Nagasaki, , Japan
Site: 2011
Nara, , Japan
Site: 2027
Sapporo, , Japan
Site: 2001
Sapporo, , Japan
Site: 2030
Sapporo, , Japan
Site: 2004
Tokyo, , Japan
Site: 2020
Tokyo, , Japan
Site: 2014
Tokyo, , Japan
Site: 2009
Tokyo, , Japan
Site: 2003
Tokyo, , Japan
Site: 2028
Tokyo, , Japan
Site: 2025
Tokyo, , Japan
Site: 2016
Tokyo, , Japan
Site: 2012
Yokohama, , Japan
Site: 1501
Bialystok, , Poland
Site: 1505
Bialystok, , Poland
Site: 1512
Gdansk, , Poland
Site: 1504
Katowice, , Poland
Site: 1508
Lublin, , Poland
Site: 1507
Lublin, , Poland
Site: 1502
Warsaw, , Poland
Site: 1509
Warsaw, , Poland
Site: 1525
Warzawa, , Poland
Site: 1604
Brasov, , Romania
Site: 1607
Bucaresti, , Romania
Site: 1602
Bucharest, , 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, , United Kingdom
Site: 1804
Norwich, , United Kingdom
Site: 1808
Sheffield, , United Kingdom
Site: 1806
Southampton, , United Kingdom
Countries
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References
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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.
Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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2012-002791-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1707-CL-0011
Identifier Type: -
Identifier Source: org_study_id
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