Clinical trial NCT01767090: A Study to Assess the Effectiveness and Safety of Different Doses of ASP1707 Compared to Placebo for Endometriosis Associated Pelvic Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: Phase 2
Double-blind
Pelvic pain
ASP1707
Placebo-controlled
Endometriosis
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-01-14
Enrollment: 912
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to the end of 12 weeks treatment of pain score for overall pelvic pain
timeFrame: Baseline & Week 12
measure: Change from baseline to the end of 12 weeks treatment of pain score for dysmenorrhea
timeFrame: Baseline & Week 12
measure: Change from baseline to the end of 12 weeks treatment of pain score for non-menstrual pelvic pain
timeFrame: Baseline & Week 12
Secondary outcomes:
measure: Change from baseline to the end of 24 weeks treatment of pain score for overall pelvic pain
timeFrame: Baseline & Week 24
measure: Change from baseline to the end of 24 weeks treatment of pain score for dysmenorrhea
timeFrame: Baseline & Week 24
measure: Change from baseline to the end of 24 weeks treatment of pain score for non-menstrual pelvic pain
timeFrame: Baseline & Week 24
measure: Change from baseline to the end of treatment (EoT) of the dyspareunia score
timeFrame: Baseline, Week 12 & Week 24
measure: Occurrence of response at the EoT for pain score for overall pelvic pain, dysmenorrhea, non-menstrual pelvic pain and dyspareunia
timeFrame: Week 12 & Week 24
measure: Change from baseline to the EoT of the mean scores of the modified Biberoglu and Behrman (B&B) symptom and sign domains
timeFrame: Baseline, Week 12 & Week 24
measure: Change from baseline to the EoT of the use of protocol defined rescue medication
timeFrame: Baseline, Week 12 & Week 24
measure: Change from baseline to the EoT of the mean Pain Interference score of the Brief Pain Inventory
timeFrame: Baseline, Week 12 & Week 24
measure: Patient Global Impression of Change (PGIC) at the End of Treatment
timeFrame: Week 12 & Week 24
measure: Change from baseline to the EoT in the Endometriosis Health Profile (EHP)-5 score
timeFrame: Baseline, Week 12 & Week 24
measure: Change from baseline to the EoT of the Female Sexual Function Index (FSFI) score (sexual well-being)
timeFrame: Baseline, Week 12 & Week 24
measure: Change from baseline to the EoT of the Beck's Depression Inventory (BDI)-II score
timeFrame: Baseline, Week 12 & Week 24
measure: Change from baseline to the EoT in the EuroQol (EQ-5D-5L) score
timeFrame: Baseline, Week 12 & Week 24
measure: Safety and tolerability of ASP1707 measured by Adverse Events (AEs), bleeding patterns, Bone Mineral Density (BMD)
timeFrame: Up to Week 42
measure: Pharmacodynamic profile of ASP1707 measured by Serum Estradiol (E2) levels
timeFrame: Up to Week 26
measure: Pharmacokinetic profile of ASP1707
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Site: 1006
city: Genk
country: Belgium
facility: Site: 1002
city: Gent
country: Belgium
facility: Site: 1003
city: Leuven
country: Belgium
facility: Site: 1001
city: Liege
country: Belgium
facility: Site: 1005
city: Plovdiv
country: Bulgaria
facility: Site: 1105
city: Sofia
country: Bulgaria
facility: Site: 1104
city: Sofia
country: Bulgaria
facility: Site: 1107
city: Sofia
country: Bulgaria
facility: Site: 1106
city: Sofia
country: Bulgaria
facility: Site: 1102
city: Stara Zagora
country: Bulgaria
facility: Site: 1103
city: Berlin
country: Germany
facility: Site: 1390
city: Dresden
country: Germany
facility: Site: 1304
city: Erlangen
country: Germany
facility: Site: 1302
city: Karlsruhe
country: Germany
facility: Site: 1311
city: Luebeck
country: Germany
facility: Site: 1306
city: Kecskemet
country: Hungary
facility: Site: 1422
state: Bacs-Kiskun Megye
city: Budapest
country: Hungary
facility: Site: 1401
city: Budapest
country: Hungary
facility: Site: 1407
city: Debrecen
country: Hungary
facility: Site: 1408
city: Pecs
country: Hungary
facility: Site: 1406
city: Szekesfehervar
country: Hungary
facility: Site: 1402
city: Szekszard
country: Hungary
facility: Site: 1403
city: Aomori
country: Japan
facility: Site: 2018
city: Chiba
country: Japan
facility: Site: 2017
city: Fujisawa
country: Japan
facility: Site: 2005
city: Hyogo
country: Japan
facility: Site: 2034
city: Hyogo
country: Japan
facility: Site: 2039
city: Hyogo
country: Japan
facility: Site: 2040
city: Kagoshima
country: Japan
facility: Site: 2032
city: Kanagawa
country: Japan
facility: Site: 2015
city: Kanagawa
country: Japan
facility: Site: 2035
city: Kawagoe
country: Japan
facility: Site: 2013
city: Kawasaki
country: Japan
facility: Site: 2029
city: Kawasaki
country: Japan
facility: Site: 2024
city: Kochi
country: Japan
facility: Site: 2033
city: Kumamoto
country: Japan
facility: Site: 2031
city: Kurashiki
country: Japan
facility: Site: 2010
city: Kyoto
country: Japan
facility: Site: 2006
city: Nagano
country: Japan
facility: Site: 2036
city: Nagano
country: Japan
facility: Site: 2037
city: Nagano
country: Japan
facility: Site: 2038
city: Nagaoka
country: Japan
facility: Site: 2002
city: Nagasaki
country: Japan
facility: Site: 2007
city: Nara
country: Japan
facility: Site: 2011
city: Sapporo
country: Japan
facility: Site: 2027
city: Sapporo
country: Japan
facility: Site: 2001
city: Sapporo
country: Japan
facility: Site: 2030
city: Tokyo
country: Japan
facility: Site: 2004
city: Tokyo
country: Japan
facility: Site: 2020
city: Tokyo
country: Japan
facility: Site: 2014
city: Tokyo
country: Japan
facility: Site: 2009
city: Tokyo
country: Japan
facility: Site: 2003
city: Tokyo
country: Japan
facility: Site: 2028
city: Tokyo
country: Japan
facility: Site: 2025
city: Tokyo
country: Japan
facility: Site: 2016
city: Yokohama
country: Japan
facility: Site: 2012
city: Bialystok
country: Poland
facility: Site: 1501
city: Bialystok
country: Poland
facility: Site: 1505
city: Gdansk
country: Poland
facility: Site: 1512
city: Katowice
country: Poland
facility: Site: 1504
city: Lublin
country: Poland
facility: Site: 1508
city: Lublin
country: Poland
facility: Site: 1507
city: Warsaw
country: Poland
facility: Site: 1509
city: Warszawa
country: Poland
facility: Site: 1502
city: Warzawa
country: Poland
facility: Site: 1525
city: Brasov
country: Romania
facility: Site: 1604
city: Bucaresti
country: Romania
facility: Site: 1607
city: Bucharest
country: Romania
facility: Site: 1602
city: Bucuresti
country: Romania
facility: Site: 1601
city: Bucuresti
country: Romania
facility: Site: 1606
city: Targu Mures
country: Romania
facility: Site: 1603
city: Bucuresti
country: Ukraine
facility: Site: 1701
city: Bucuresti
country: Ukraine
facility: Site: 1702
city: Bucuresti
country: Ukraine
facility: Site: 1705
city: Bucuresti
country: Ukraine
facility: Site: 1707
city: Donetsk
country: Ukraine
facility: Site: 1713
city: Donetsk
country: Ukraine
facility: Site: 1716
city: Kyiv
country: Ukraine
facility: Site: 1708
city: Targu Mures
country: Ukraine
facility: Site: 1703
city: Zaporizhzhya
country: Ukraine
facility: Site: 1717
city: London
country: United Kingdom
facility: Site: 1807
city: Norwich
country: United Kingdom
facility: Site: 1804
city: Sheffield
country: United Kingdom
facility: Site: 1808
city: Southampton
country: United Kingdom
facility: Site: 1806
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Clinical Study Manager
role: STUDY_CHAIR
References:
citation: 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.