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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002791-14 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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 lowest dose | Experimental | 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 | Experimental | 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 | Experimental | 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 high dose | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP1707 | Drug | Oral |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Study Manager | Astellas Pharma Europe B.V. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site: 1006 | Brussels | 1200 | Belgium | |||
| Site: 1002 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31067329 | Derived | 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. |
| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results website | View source |
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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/.
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.
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.
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|
| Leuprorelin acetate | Active Comparator | Subjects in this arm will be treated with leuprorelin acetate for a total of 24 weeks |
|
| Placebo | Drug | Oral |
|
| Leuprorelin acetate | Drug | subcutaneous |
|
|
| 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 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 EoT in the Endometriosis Health Profile (EHP)-5 score | 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 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 | Both CL/F, V/F, AUCtau, Cmax, Ctrough | Up to Week 24 |
| 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 |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000708087 | opigolix |
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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