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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

Primary Purpose

Endometriosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ASP1707
Placebo
Leuprorelin acetate
Sponsored by
Astellas Pharma Europe B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Phase 2, Double-blind, Pelvic pain, ASP1707, Placebo-controlled, Endometriosis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Site: 1006
  • Site: 1002
  • Site: 1003
  • Site: 1001
  • Site: 1005
  • Site: 1105
  • Site: 1104
  • Site: 1107
  • Site: 1106
  • Site: 1102
  • Site: 1103
  • Site: 1390
  • Site: 1304
  • Site: 1302
  • Site: 1311
  • Site: 1306
  • Site: 1422
  • Site: 1401
  • Site: 1407
  • Site: 1408
  • Site: 1406
  • Site: 1402
  • Site: 1403
  • Site: 2018
  • Site: 2017
  • Site: 2005
  • Site: 2034
  • Site: 2039
  • Site: 2040
  • Site: 2032
  • Site: 2015
  • Site: 2035
  • Site: 2013
  • Site: 2029
  • Site: 2024
  • Site: 2033
  • Site: 2031
  • Site: 2010
  • Site: 2006
  • Site: 2036
  • Site: 2037
  • Site: 2038
  • Site: 2002
  • Site: 2007
  • Site: 2011
  • Site: 2027
  • Site: 2001
  • Site: 2030
  • Site: 2004
  • Site: 2020
  • Site: 2014
  • Site: 2009
  • Site: 2003
  • Site: 2028
  • Site: 2025
  • Site: 2016
  • Site: 2012
  • Site: 1501
  • Site: 1505
  • Site: 1512
  • Site: 1504
  • Site: 1508
  • Site: 1507
  • Site: 1509
  • Site: 1502
  • Site: 1525
  • Site: 1604
  • Site: 1607
  • Site: 1602
  • Site: 1601
  • Site: 1606
  • Site: 1603
  • Site: 1701
  • Site: 1702
  • Site: 1705
  • Site: 1707
  • Site: 1713
  • Site: 1716
  • Site: 1708
  • Site: 1703
  • Site: 1717
  • Site: 1807
  • Site: 1804
  • Site: 1808
  • Site: 1806

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Placebo

ASP1707 lowest dose

ASP1707 low dose

ASP1707 medium dose

ASP1707 high dose

Leuprorelin acetate

Arm Description

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)

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

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

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

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

Subjects in this arm will be treated with leuprorelin acetate for a total of 24 weeks

Outcomes

Primary Outcome Measures

Change from baseline to the end of 12 weeks treatment of pain score for overall pelvic pain
Change from baseline to the end of 12 weeks treatment of pain score for dysmenorrhea
Change from baseline to the end of 12 weeks treatment of pain score for non-menstrual pelvic pain

Secondary Outcome Measures

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

Full Information

First Posted
December 18, 2012
Last Updated
March 27, 2019
Sponsor
Astellas Pharma Europe B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT01767090
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 4, 2012 (Actual)
Primary Completion Date
May 13, 2015 (Actual)
Study Completion Date
July 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Europe B.V.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Phase 2, Double-blind, Pelvic pain, ASP1707, Placebo-controlled, Endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
912 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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)
Arm Title
ASP1707 lowest dose
Arm Type
Experimental
Arm Description
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
Arm Title
ASP1707 low dose
Arm Type
Experimental
Arm Description
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
Arm Title
ASP1707 medium dose
Arm Type
Experimental
Arm Description
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
Arm Title
ASP1707 high dose
Arm Type
Experimental
Arm Description
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
Arm Title
Leuprorelin acetate
Arm Type
Active Comparator
Arm Description
Subjects in this arm will be treated with leuprorelin acetate for a total of 24 weeks
Intervention Type
Drug
Intervention Name(s)
ASP1707
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Leuprorelin acetate
Other Intervention Name(s)
Prostap® SR
Intervention Description
subcutaneous
Primary Outcome Measure Information:
Title
Change from baseline to the end of 12 weeks treatment of pain score for overall pelvic pain
Time Frame
Baseline & Week 12
Title
Change from baseline to the end of 12 weeks treatment of pain score for dysmenorrhea
Time Frame
Baseline & Week 12
Title
Change from baseline to the end of 12 weeks treatment of pain score for non-menstrual pelvic pain
Time Frame
Baseline & Week 12
Secondary Outcome Measure Information:
Title
Change from baseline to the end of 24 weeks treatment of pain score for overall pelvic pain
Time Frame
Baseline & Week 24
Title
Change from baseline to the end of 24 weeks treatment of pain score for dysmenorrhea
Time Frame
Baseline & Week 24
Title
Change from baseline to the end of 24 weeks treatment of pain score for non-menstrual pelvic pain
Time Frame
Baseline & Week 24
Title
Change from baseline to the end of treatment (EoT) of the dyspareunia score
Time Frame
Baseline, Week 12 & Week 24
Title
Occurrence of response at the EoT for pain score for overall pelvic pain, dysmenorrhea, non-menstrual pelvic pain and dyspareunia
Time Frame
Week 12 & Week 24
Title
Change from baseline to the EoT of the mean scores of the modified Biberoglu and Behrman (B&B) symptom and sign domains
Time Frame
Baseline, Week 12 & Week 24
Title
Change from baseline to the EoT of the use of protocol defined rescue medication
Time Frame
Baseline, Week 12 & Week 24
Title
Change from baseline to the EoT of the mean Pain Interference score of the Brief Pain Inventory
Time Frame
Baseline, Week 12 & Week 24
Title
Patient Global Impression of Change (PGIC) at the End of Treatment
Time Frame
Week 12 & Week 24
Title
Change from baseline to the EoT in the Endometriosis Health Profile (EHP)-5 score
Time Frame
Baseline, Week 12 & Week 24
Title
Change from baseline to the EoT of the Female Sexual Function Index (FSFI) score (sexual well-being)
Time Frame
Baseline, Week 12 & Week 24
Title
Change from baseline to the EoT of the Beck's Depression Inventory (BDI)-II score
Time Frame
Baseline, Week 12 & Week 24
Title
Change from baseline to the EoT in the EuroQol (EQ-5D-5L) score
Time Frame
Baseline, Week 12 & Week 24
Title
Safety and tolerability of ASP1707 measured by Adverse Events (AEs), bleeding patterns, Bone Mineral Density (BMD)
Time Frame
Up to Week 42
Title
Pharmacodynamic profile of ASP1707 measured by Serum Estradiol (E2) levels
Time Frame
Up to Week 26
Title
Pharmacokinetic profile of ASP1707
Description
Both CL/F, V/F, AUCtau, Cmax, Ctrough
Time Frame
Up to Week 24

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Study Manager
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Chair
Facility Information:
Facility Name
Site: 1006
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Site: 1002
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Site: 1003
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Site: 1001
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Site: 1005
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Site: 1105
City
Plovdiv
Country
Bulgaria
Facility Name
Site: 1104
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
Site: 1107
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Facility Name
Site: 1106
City
Sofia
ZIP/Postal Code
1504
Country
Bulgaria
Facility Name
Site: 1102
City
Sofia
Country
Bulgaria
Facility Name
Site: 1103
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Site: 1390
City
Berlin
Country
Germany
Facility Name
Site: 1304
City
Dresden
Country
Germany
Facility Name
Site: 1302
City
Erlangen
Country
Germany
Facility Name
Site: 1311
City
Karlsruhe
Country
Germany
Facility Name
Site: 1306
City
Luebeck
Country
Germany
Facility Name
Site: 1422
City
Kecskemet
State/Province
Bacs-Kiskun Megye
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Site: 1401
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Site: 1407
City
Budapest
Country
Hungary
Facility Name
Site: 1408
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Site: 1406
City
Pecs
Country
Hungary
Facility Name
Site: 1402
City
Szekesfehervar
Country
Hungary
Facility Name
Site: 1403
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Site: 2018
City
Aomori
ZIP/Postal Code
036 8203
Country
Japan
Facility Name
Site: 2017
City
Chiba
ZIP/Postal Code
299 0111
Country
Japan
Facility Name
Site: 2005
City
Fujisawa
ZIP/Postal Code
252 0804
Country
Japan
Facility Name
Site: 2034
City
Hyogo
ZIP/Postal Code
666 0195
Country
Japan
Facility Name
Site: 2039
City
Hyogo
Country
Japan
Facility Name
Site: 2040
City
Hyogo
Country
Japan
Facility Name
Site: 2032
City
Kagoshima
Country
Japan
Facility Name
Site: 2015
City
Kanagawa
ZIP/Postal Code
213 8507
Country
Japan
Facility Name
Site: 2035
City
Kanagawa
Country
Japan
Facility Name
Site: 2013
City
Kawagoe
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Site: 2029
City
Kawasaki
ZIP/Postal Code
210 0024
Country
Japan
Facility Name
Site: 2024
City
Kawasaki
ZIP/Postal Code
212 0058
Country
Japan
Facility Name
Site: 2033
City
Kochi
ZIP/Postal Code
783 8505
Country
Japan
Facility Name
Site: 2031
City
Kumamoto
ZIP/Postal Code
861 8520
Country
Japan
Facility Name
Site: 2010
City
Kurashiki
ZIP/Postal Code
710 0824
Country
Japan
Facility Name
Site: 2006
City
Kyoto
ZIP/Postal Code
602 8566
Country
Japan
Facility Name
Site: 2036
City
Nagano
Country
Japan
Facility Name
Site: 2037
City
Nagano
Country
Japan
Facility Name
Site: 2038
City
Nagano
Country
Japan
Facility Name
Site: 2002
City
Nagaoka
ZIP/Postal Code
940 2085
Country
Japan
Facility Name
Site: 2007
City
Nagasaki
ZIP/Postal Code
850 0003
Country
Japan
Facility Name
Site: 2011
City
Nara
ZIP/Postal Code
631 0805
Country
Japan
Facility Name
Site: 2027
City
Sapporo
ZIP/Postal Code
060 0001
Country
Japan
Facility Name
Site: 2001
City
Sapporo
ZIP/Postal Code
060 0031
Country
Japan
Facility Name
Site: 2030
City
Sapporo
ZIP/Postal Code
060 0061
Country
Japan
Facility Name
Site: 2004
City
Tokyo
ZIP/Postal Code
101 0062
Country
Japan
Facility Name
Site: 2020
City
Tokyo
ZIP/Postal Code
107 0052
Country
Japan
Facility Name
Site: 2014
City
Tokyo
ZIP/Postal Code
113 8431
Country
Japan
Facility Name
Site: 2009
City
Tokyo
ZIP/Postal Code
113 8603
Country
Japan
Facility Name
Site: 2003
City
Tokyo
ZIP/Postal Code
1130033
Country
Japan
Facility Name
Site: 2028
City
Tokyo
ZIP/Postal Code
141 0022
Country
Japan
Facility Name
Site: 2025
City
Tokyo
ZIP/Postal Code
157 0061
Country
Japan
Facility Name
Site: 2016
City
Tokyo
Country
Japan
Facility Name
Site: 2012
City
Yokohama
ZIP/Postal Code
225 0024
Country
Japan
Facility Name
Site: 1501
City
Bialystok
ZIP/Postal Code
15-464
Country
Poland
Facility Name
Site: 1505
City
Bialystok
Country
Poland
Facility Name
Site: 1512
City
Gdansk
Country
Poland
Facility Name
Site: 1504
City
Katowice
ZIP/Postal Code
40-724
Country
Poland
Facility Name
Site: 1508
City
Lublin
ZIP/Postal Code
20-333
Country
Poland
Facility Name
Site: 1507
City
Lublin
ZIP/Postal Code
20-632
Country
Poland
Facility Name
Site: 1509
City
Warsaw
Country
Poland
Facility Name
Site: 1502
City
Warszawa
ZIP/Postal Code
02-066
Country
Poland
Facility Name
Site: 1525
City
Warzawa
Country
Poland
Facility Name
Site: 1604
City
Brasov
Country
Romania
Facility Name
Site: 1607
City
Bucaresti
Country
Romania
Facility Name
Site: 1602
City
Bucharest
ZIP/Postal Code
11475
Country
Romania
Facility Name
Site: 1601
City
Bucuresti
Country
Romania
Facility Name
Site: 1606
City
Bucuresti
Country
Romania
Facility Name
Site: 1603
City
Targu Mures
Country
Romania
Facility Name
Site: 1701
City
Bucuresti
Country
Ukraine
Facility Name
Site: 1702
City
Bucuresti
Country
Ukraine
Facility Name
Site: 1705
City
Bucuresti
Country
Ukraine
Facility Name
Site: 1707
City
Bucuresti
Country
Ukraine
Facility Name
Site: 1713
City
Donetsk
Country
Ukraine
Facility Name
Site: 1716
City
Donetsk
Country
Ukraine
Facility Name
Site: 1708
City
Kyiv
Country
Ukraine
Facility Name
Site: 1703
City
Targu Mures
Country
Ukraine
Facility Name
Site: 1717
City
Zaporizhzhya
Country
Ukraine
Facility Name
Site: 1807
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Site: 1804
City
Norwich
ZIP/Postal Code
NR47UY
Country
United Kingdom
Facility Name
Site: 1808
City
Sheffield
ZIP/Postal Code
S10 2SF
Country
United Kingdom
Facility Name
Site: 1806
City
Southampton
ZIP/Postal Code
SO16 5YA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Citations:
PubMed Identifier
31067329
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.
Results Reference
derived
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=305
Description
Link to results on the Astellas Clinical Study Results website

Learn more about this trial

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

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