A Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy, Safety and Duration of Effect of a Single Administration of Various Doses of Cetrorelix SR in Subjects With Histologically Confirmed Endometriosis

Sponsor

Solvay Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00244452

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

Brief Summary

Identify effective doses of cetrorelix SR in the treatment of symptoms of endometriosis, describe dose effect relationship and duration of symptom relief

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: Cetrorelix	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy, Safety and Duration of Effect of a Single Administration of Various Doses of Cetrorelix SR in Subjects With Histologically Confirmed Endometriosis

Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Sep 1, 2006

Actual Study Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Premenopausal female,
history of regular menstrual periods,
any of the symptoms dysmenorrhea,
dyspareunia or pelvic pain assessed as moderate to severe,
endometriosis confirmed by histology within 36 months,
use of barrier contraception throughout the study

Exclusion Criteria:

Insufficient wash out period for other endometriosis treatments,
resection or destruction of endometriotic lesions less than 12 weeks prior to screening,
need for strong opioid analgesics,
need for immediate surgical treatment of endometriosis,
any condition that interferes with adherence to study procedures or study assessments

Contacts and Locations

Locations

	Site	City	Country
1	Site 6101	Clayton	Australia
2	Site 6103	Nedlands	Australia
3	Site 6104	Randwick	Australia
4	Site 6102	Sydney	Australia
5	Site 3201	Aalter	Belgium
6	Site 3202	Brussels	Belgium
7	Site 3203	Leuven	Belgium
8	Site 3501	Sofia	Bulgaria
9	Site 3502	Sofia	Bulgaria
10	Site 3503	Sofia	Bulgaria
11	Site 3504	Sofia	Bulgaria
12	Site 3505	Sofia	Bulgaria
13	Site 3506	Sofia	Bulgaria
14	Site 4904	Berlin	Germany
15	Site 4905	Dresden	Germany
16	Site 4903	Heidelberg	Germany
17	Site 4901	Herne	Germany
18	Site 4902	Tuebingen	Germany
19	Site 4000	Bucuresti	Romania
20	Site 4001	Bucuresti	Romania
21	Site 4002	Bucuresti	Romania
22	Site 4004	Bucuresti	Romania
23	Site 4005	Bucuresti	Romania
24	Site 4006	Bucuresti	Romania
25	Site 4007	Bucuresti	Romania
26	Site 4009	Bucuresti	Romania
27	Site 4008	Constanta	Romania
28	Site 4003	Craiova	Romania
29	Site 0701	Moscow	Russian Federation
30	Site 0901	Moscow	Russian Federation
31	Site 0902	Moscow	Russian Federation
32	Site 0903	Moscow	Russian Federation
33	Site 0904	Moscow	Russian Federation
34	Site 0905	Moscow	Russian Federation
35	Site 0906	Moscow	Russian Federation
36	Site 0907	Moscow	Russian Federation
37	Site 0908	Moscow	Russian Federation
38	Site 0909	Moscow	Russian Federation
39	Site 0702	St. Petersburg	Russian Federation
40	Site 0703	St. Petersburg	Russian Federation
41	Site 0704	St. Petersburg	Russian Federation
42	Site 0705	St. Petersburg	Russian Federation
43	Site 0706	St. Petersburg	Russian Federation
44	Site 0707	St. Petersburg	Russian Federation
45	Site 2705	Bloemfontein	South Africa
46	Site 2703	Cape Town	South Africa
47	Site 2702	Centurion	South Africa
48	Site 2701	Roodepoort	South Africa
49	Site 2704	Roodepoort	South Africa
50	Site 3805	Dnepropetrovsk	Ukraine
51	Site 3801	Donetsk	Ukraine
52	Site 3803	Kiev	Ukraine
53	Site 3806	Kiev	Ukraine
54	Site 3807	Kiev	Ukraine
55	Site 3808	Kiev	Ukraine
56	Site 3802	Odessa	Ukraine
57	Site 3804	Zaporozhye	Ukraine