Study Details

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A study to assess the effectiveness and safety of different doses of ASP1707 compared to placebo for endometriosis associated pelvic pain

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01767090

Astellas Study ID

The unique identification code given by the study sponsor.

1707-CL-0011

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2012-002791-14

Follow Trial

Condition

Pain & Menstrual Irregularities

Phase

These clinical trials are done to learn if an experimental treatment helps participants who have a specific condition or disease. Phase 2 trials usually include a larger group of participants than Phase 1 trials.

Phase 2

Age

18 years - 45 years

Sex

Female

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Dec 2012 - Jul 2015

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment number

912

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

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Site: 1717

Zaporizhzhya, Ukraine

Site: 2004

Tokyo, Japan, 101 0062

Site: 2031

Kumamoto, Japan, 861 8520

Site: 2014

Tokyo, Japan, 113 8431

Site: 1703

Targu Mures, Ukraine

Site: 1406

Pecs, Hungary

Site: 2035

Kanagawa, Japan

Site: 2001

Sapporo, Japan, 060 0031

Site: 2015

Kanagawa, Japan, 213 8507

Site: 2024

Kawasaki, Japan, 212 0058

Site: 1602

Bucharest, Romania, 11475

Site: 1104

Sofia, Bulgaria, 1000

Site: 1704

Brasov, Ukraine

Site: 1102

Sofia, Bulgaria

Site: 1801

Edinburgh, United Kingdom, EH16 4TJ

Site: 2033

Kochi, Japan, 783 8505

Site: 2009

Tokyo, Japan, 113 8603

Site: 1702

Bucuresti, Ukraine

Site: 1701

Bucuresti, Ukraine

Site: 2038

Nagano, Japan

Site: 1512

Gdansk, Poland

Site: 1527

Krakow, Poland

Site: 1308

Hamburg, Germany

Site: 1508

Lublin, Poland, 20-333

Site: 2019

Sendai, Japan

Site: 1109

Burgas, Bulgaria

Site: 1304

Dresden, Germany

Site: 2017

Chiba, Japan, 299 0111

Site: 1106

Sofia, Bulgaria, 1504

Site: 1806

Southampton, United Kingdom, SO16 5YA

Site: 2032

Kagoshima, Japan

Site: 1403

Szekszard, Hungary, 7100

Site: 1401

Budapest, Hungary, 1135

Site: 1305

Frankfurt, Germany

Site: 2036

Nagano, Japan

Site: 1302

Erlangen, Germany

Site: 2020

Tokyo, Japan, 107 0052

Site: 1310

Essen, Germany

Site: 1504

Katowice, Poland, 40-724

Site: 1606

Bucuresti, Romania

Site: 1716

Donetsk, Ukraine

Site: 1003

Gent, Belgium, 9000

Site: 1404

Budapest, Hungary

Site: 1804

Norwich, United Kingdom, NR47UY

Site: 1103

Stara Zagora, Bulgaria, 6000

Site: 2040

Hyogo, Japan

Site: 2037

Nagano, Japan

Site: 1306

Luebeck, Germany

Site: 1311

Karlsruhe, Germany

Site: 2005

Fujisawa, Japan, 252 0804

Site: 2034

Hyogo, Japan, 666 0195

Site: 1509

Warsaw, Poland

Site: 1407

Budapest, Hungary

Site: 2013

Kawagoe, Japan, 350-8550

Site: 2027

Sapporo, Japan, 060 0001

Site: 1390

Berlin, Germany

Site: 1004

Brussels, Belgium

Site: 1807

London, United Kingdom, SE5 9RS

Site: 2029

Kawasaki, Japan, 210 0024

Site: 2025

Tokyo, Japan, 157 0061

Site: 1713

Donetsk, Ukraine

Site: 2016

Tokyo, Japan

Site: 1005

Liege, Belgium, 4000

Site: 1708

Kyiv, Ukraine

Site: 2003

Tokyo, Japan, 1130033

Site: 2010

Kurashiki, Japan, 710 0824

Site: 1808

Sheffield, United Kingdom, S10 2SF

Site: 2007

Nagasaki, Japan, 850 0003

Site: 1607

Bucaresti, Romania

Site: 1506

Warsaw, Poland

Site: 2006

Kyoto, Japan, 602 8566

Site: 1526

Piaseczno, Poland

Site: 1507

Lublin, Poland, 20-632

Site: 1422

Kecskemet, Hungary, 6000

Site: 1501

Bialystok, Poland, 15-464

Site: 1107

Sofia, Bulgaria, 1330

Site: 1605

Bucharest, Romania, 20762

Site: 2018

Aomori, Japan, 036 8203

Site: 1001

Leuven, Belgium, 3000

Site: 1408

Debrecen, Hungary, 4012

Site: 1002

Genk, Belgium, 3600

Site: 2011

Nara, Japan, 631 0805

Site: 1405

Szentes, Hungary

Site: 1604

Brasov, Romania

Site: 1603

Targu Mures, Romania

Site: 2012

Yokohama, Japan, 225 0024

Site: 2039

Hyogo, Japan

Site: 1525

Warzawa, Poland

Site: 1006

Bruxelles, Belgium, 1200

Site: 1105

Plovdiv, Bulgaria

Site: 1705

Bucuresti, Ukraine

Site: 1601

Bucuresti, Romania

Site: 2030

Sapporo, Japan, 060 0061

Site: 1402

Szekesfehervar, Hungary

Site: 1505

Bialystok, Poland

Site: 1802

Oxford, United Kingdom

Site: 1707

Bucuresti, Ukraine

Site: 1706

Bucuresti, Ukraine

Site: 2028

Tokyo, Japan, 141 0022

Site: 2002

Nagaoka, Japan, 940 2085

Site: 1502

Warszawa, Poland, 02-066

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