Efficacy and safety of ASP1707 for endometriosis-associated pelvic pain: the phase II randomized controlled TERRA study.
Thomas D'Hooghe, Takao Fukaya, Yutaka Osuga...
https://pubmed.ncbi.nlm.nih.gov/31067329Completed
Phase 2
Age: 18Years - 45Years
FEMALE
ID01767090
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
Led by Astellas Pharma Europe B.V. · Updated on 2024-10-23
912
Participants Needed
85
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Assess the Effectiveness and Safety of Different Doses of ASP1707 Compared to Placebo for Endometriosis Associated Pelvic Pain
Who Can Participate
Age: 18Years - 45Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Pre menopausal female adults with confirmed length and regular menstrual cycle
- Surgically diagnosed endometriosis
- Moderate to severe endometriosis related pain
You will not qualify if you...
- 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
Trial Site Locations
Total: 85 locations
1
Site: 1006
Brussels, Belgium, 1200
Status Unknown
2
Site: 1002
Genk, Belgium, 3600
Status Unknown
3
Site: 1003
Ghent, Belgium, 9000
Status Unknown
4
Site: 1001
Leuven, Belgium, 3000
Status Unknown
5
Site: 1005
Liège, Belgium, 4000
Status Unknown
6
Site: 1105
Plovdiv, Bulgaria
Status Unknown
7
Site: 1104
Sofia, Bulgaria, 1000
Status Unknown
8
Site: 1107
Sofia, Bulgaria, 1330
Status Unknown
9
Site: 1106
Sofia, Bulgaria, 1504
Status Unknown
10
Site: 1102
Sofia, Bulgaria
Status Unknown
11
Site: 1103
Stara Zagora, Bulgaria, 6000
Status Unknown
12
Site: 1390
Berlin, Germany
Status Unknown
13
Site: 1304
Dresden, Germany
Status Unknown
14
Site: 1302
Erlangen, Germany
Status Unknown
15
Site: 1311
Karlsruhe, Germany
Status Unknown
16
Site: 1306
Lübeck, Germany
Status Unknown
17
Site: 1422
Kecskemét, Bacs-Kiskun Megye, Hungary, 6000
Status Unknown
18
Site: 1401
Budapest, Hungary, 1135
Status Unknown
19
Site: 1407
Budapest, Hungary
Status Unknown
20
Site: 1408
Debrecen, Hungary, 4012
Status Unknown
21
Site: 1406
Pécs, Hungary
Status Unknown
22
Site: 1403
Szekszárd, Hungary, 7100
Status Unknown
23
Site: 1402
Székesfehérvár, Hungary
Status Unknown
24
Site: 2018
Aomori, Japan, 036 8203
Status Unknown
25
Site: 2017
Chiba, Japan, 299 0111
Status Unknown
26
Site: 2005
Fujisawa, Japan, 252 0804
Status Unknown
27
Site: 2034
Hyōgo, Japan, 666 0195
Status Unknown
28
Site: 2039
Hyōgo, Japan
Status Unknown
29
Site: 2040
Hyōgo, Japan
Status Unknown
30
Site: 2032
Kagoshima, Japan
Status Unknown
31
Site: 2015
Kanagawa, Japan, 213 8507
Status Unknown
32
Site: 2035
Kanagawa, Japan
Status Unknown
33
Site: 2013
Kawagoe, Japan, 350-8550
Status Unknown
34
Site: 2029
Kawasaki, Japan, 210 0024
Status Unknown
35
Site: 2024
Kawasaki, Japan, 212 0058
Status Unknown
36
Site: 2033
Kochi, Japan, 783 8505
Status Unknown
37
Site: 2031
Kumamoto, Japan, 861 8520
Status Unknown
38
Site: 2010
Kurashiki, Japan, 710 0824
Status Unknown
39
Site: 2006
Kyoto, Japan, 602 8566
Status Unknown
40
Site: 2036
Nagano, Japan
Status Unknown
41
Site: 2037
Nagano, Japan
Status Unknown
42
Site: 2038
Nagano, Japan
Status Unknown
43
Site: 2002
Nagaoka, Japan, 940 2085
Status Unknown
44
Site: 2007
Nagasaki, Japan, 850 0003
Status Unknown
45
Site: 2011
Nara, Japan, 631 0805
Status Unknown
46
Site: 2027
Sapporo, Japan, 060 0001
Status Unknown
47
Site: 2001
Sapporo, Japan, 060 0031
Status Unknown
48
Site: 2030
Sapporo, Japan, 060 0061
Status Unknown
49
Site: 2004
Tokyo, Japan, 101 0062
Status Unknown
50
Site: 2020
Tokyo, Japan, 107 0052
Status Unknown
51
Site: 2014
Tokyo, Japan, 113 8431
Status Unknown
52
Site: 2009
Tokyo, Japan, 113 8603
Status Unknown
53
Site: 2003
Tokyo, Japan, 1130033
Status Unknown
54
Site: 2028
Tokyo, Japan, 141 0022
Status Unknown
55
Site: 2025
Tokyo, Japan, 157 0061
Status Unknown
56
Site: 2016
Tokyo, Japan
Status Unknown
57
Site: 2012
Yokohama, Japan, 225 0024
Status Unknown
58
Site: 1501
Bialystok, Poland, 15-464
Status Unknown
59
Site: 1505
Bialystok, Poland
Status Unknown
60
Site: 1512
Gdansk, Poland
Status Unknown
61
Site: 1504
Katowice, Poland, 40-724
Status Unknown
62
Site: 1508
Lublin, Poland, 20-333
Status Unknown
63
Site: 1507
Lublin, Poland, 20-632
Status Unknown
64
Site: 1502
Warsaw, Poland, 02-066
Status Unknown
65
Site: 1509
Warsaw, Poland
Status Unknown
66
Site: 1525
Warzawa, Poland
Status Unknown
67
Site: 1604
Brasov, Romania
Status Unknown
68
Site: 1607
Bucaresti, Romania
Status Unknown
69
Site: 1602
Bucharest, Romania, 11475
Status Unknown
70
Site: 1601
Bucharest, Romania
Status Unknown
71
Site: 1606
Bucharest, Romania
Status Unknown
72
Site: 1603
Târgu Mureş, Romania
Status Unknown
73
Site: 1701
Bucuresti, Ukraine
Status Unknown
74
Site: 1702
Bucuresti, Ukraine
Status Unknown
75
Site: 1705
Bucuresti, Ukraine
Status Unknown
76
Site: 1707
Bucuresti, Ukraine
Status Unknown
77
Site: 1713
Donetsk, Ukraine
Status Unknown
78
Site: 1716
Donetsk, Ukraine
Status Unknown
79
Site: 1708
Kyiv, Ukraine
Status Unknown
80
Site: 1703
Targu Mures, Ukraine
Status Unknown
81
Site: 1717
Zaporizhzhya, Ukraine
Status Unknown
82
Site: 1807
London, United Kingdom, SE5 9RS
Status Unknown
83
Site: 1804
Norwich, United Kingdom, NR47UY
Status Unknown
84
Site: 1808
Sheffield, United Kingdom, S10 2SF
Status Unknown
85
Site: 1806
Southampton, United Kingdom, SO16 5YA
Status Unknown
Loading map...
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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