A Study to Assess the Effectiveness and Safety of Different Doses of ASP1707 Compared to Placebo for Endometriosis Associated Pelvic Pain

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01767090
• Other study ID #: 1707-CL-0011
• Secondary ID: 2012-002791-14
• Status: Completed
• Phase: Phase 2
• Start date: December 4, 2012
• Est. completion date: July 30, 2015

Study information

• Verified date: March 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 912
• Est. completion date: July 30, 2015
• Est. primary completion date: May 13, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pre menopausal female adults with confirmed length and regular menstrual cycle

• Surgically diagnosed endometriosis

• Moderate to severe endometriosis related pain

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Endometriosis
• Pelvic Pain

Intervention

Drug:
• ASP1707
Oral
• Placebo
Oral
• Leuprorelin acetate
subcutaneous

Locations

Country	Name	City	State
Belgium	Site: 1006	Bruxelles
Belgium	Site: 1002	Genk
Belgium	Site: 1003	Gent
Belgium	Site: 1001	Leuven
Belgium	Site: 1005	Liege
Bulgaria	Site: 1105	Plovdiv
Bulgaria	Site: 1102	Sofia
Bulgaria	Site: 1104	Sofia
Bulgaria	Site: 1106	Sofia
Bulgaria	Site: 1107	Sofia
Bulgaria	Site: 1103	Stara Zagora
Germany	Site: 1390	Berlin
Germany	Site: 1304	Dresden
Germany	Site: 1302	Erlangen
Germany	Site: 1311	Karlsruhe
Germany	Site: 1306	Luebeck
Hungary	Site: 1401	Budapest
Hungary	Site: 1407	Budapest
Hungary	Site: 1408	Debrecen
Hungary	Site: 1422	Kecskemet	Bacs-Kiskun Megye
Hungary	Site: 1406	Pecs
Hungary	Site: 1402	Szekesfehervar
Hungary	Site: 1403	Szekszard
Japan	Site: 2018	Aomori
Japan	Site: 2017	Chiba
Japan	Site: 2005	Fujisawa
Japan	Site: 2034	Hyogo
Japan	Site: 2039	Hyogo
Japan	Site: 2040	Hyogo
Japan	Site: 2032	Kagoshima
Japan	Site: 2015	Kanagawa
Japan	Site: 2035	Kanagawa
Japan	Site: 2013	Kawagoe
Japan	Site: 2024	Kawasaki
Japan	Site: 2029	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: 2001	Sapporo
Japan	Site: 2027	Sapporo
Japan	Site: 2030	Sapporo
Japan	Site: 2003	Tokyo
Japan	Site: 2004	Tokyo
Japan	Site: 2009	Tokyo
Japan	Site: 2014	Tokyo
Japan	Site: 2016	Tokyo
Japan	Site: 2020	Tokyo
Japan	Site: 2025	Tokyo
Japan	Site: 2028	Tokyo
Japan	Site: 2012	Yokohama
Poland	Site: 1501	Bialystok
Poland	Site: 1505	Bialystok
Poland	Site: 1512	Gdansk
Poland	Site: 1504	Katowice
Poland	Site: 1507	Lublin
Poland	Site: 1508	Lublin
Poland	Site: 1509	Warsaw
Poland	Site: 1502	Warszawa
Poland	Site: 1525	Warzawa
Romania	Site: 1604	Brasov
Romania	Site: 1607	Bucaresti
Romania	Site: 1602	Bucharest
Romania	Site: 1601	Bucuresti
Romania	Site: 1606	Bucuresti
Romania	Site: 1603	Targu Mures
Ukraine	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
United Kingdom	Site: 1807	London
United Kingdom	Site: 1804	Norwich
United Kingdom	Site: 1808	Sheffield
United Kingdom	Site: 1806	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Germany,  Hungary,  Japan,  Poland,  Romania,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to the end of 12 weeks treatment of pain score for overall pelvic pain		Baseline & Week 12
Primary	Change from baseline to the end of 12 weeks treatment of pain score for dysmenorrhea		Baseline & Week 12
Primary	Change from baseline to the end of 12 weeks treatment of pain score for non-menstrual pelvic pain		Baseline & Week 12
Secondary	Change from baseline to the end of 24 weeks treatment of pain score for overall pelvic pain		Baseline & Week 24
Secondary	Change from baseline to the end of 24 weeks treatment of pain score for dysmenorrhea		Baseline & Week 24
Secondary	Change from baseline to the end of 24 weeks treatment of pain score for non-menstrual pelvic pain		Baseline & Week 24
Secondary	Change from baseline to the end of treatment (EoT) of the dyspareunia score		Baseline, Week 12 & Week 24
Secondary	Occurrence of response at the EoT for pain score for overall pelvic pain, dysmenorrhea, non-menstrual pelvic pain and dyspareunia		Week 12 & Week 24
Secondary	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
Secondary	Change from baseline to the EoT of the use of protocol defined rescue medication		Baseline, Week 12 & Week 24
Secondary	Change from baseline to the EoT of the mean Pain Interference score of the Brief Pain Inventory		Baseline, Week 12 & Week 24
Secondary	Patient Global Impression of Change (PGIC) at the End of Treatment		Week 12 & Week 24
Secondary	Change from baseline to the EoT in the Endometriosis Health Profile (EHP)-5 score		Baseline, Week 12 & Week 24
Secondary	Change from baseline to the EoT of the Female Sexual Function Index (FSFI) score (sexual well-being)		Baseline, Week 12 & Week 24
Secondary	Change from baseline to the EoT of the Beck's Depression Inventory (BDI)-II score		Baseline, Week 12 & Week 24
Secondary	Change from baseline to the EoT in the EuroQol (EQ-5D-5L) score		Baseline, Week 12 & Week 24
Secondary	Safety and tolerability of ASP1707 measured by Adverse Events (AEs), bleeding patterns, Bone Mineral Density (BMD)		Up to Week 42
Secondary	Pharmacodynamic profile of ASP1707 measured by Serum Estradiol (E2) levels		Up to Week 26
Secondary	Pharmacokinetic profile of ASP1707	Both CL/F, V/F, AUCtau, Cmax, Ctrough	Up to Week 24

External Links

•   Link to results on the Astellas Clinical Study Results website