Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00318500

Collaborator

(none)

150

Enrollment

Locations

Duration (Months)

2.1

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of two doses of ERB-041 (75 mg and 150 mg) relative to placebo on the relief of endometriosis-related symptoms (dysmenorrhea, pelvic pain, and deep dyspareunia) in reproductive aged women.

Condition or Disease	Intervention/Treatment	Phase
Dysmenorrhea Dyspareunia Endometriosis Pelvic Pain	Drug: ERB-041	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 75 mg and 150 mg Doses of ERB-041 on the Reduction of Symptoms Associated With Endometriosis During Treatment and Post Treatment in Reproductive-Aged Women

Study Start Date :

May 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

severity scores for dysmenorrhea, pelvic pain and deep dyspareunia from baseline through 12 weeks of treatment using the B & B scale administered by the investigator []

Secondary Outcome Measures

change in severity scores for pelvic tenderness and pelvic induration during 12 weeks of treatment []
change in rescue medication use []
change in health related quality of life questionnaires []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Surgical diagnosis of endometriosis within the last 10 years
Sexually active, nonpregnant, nonlactating women (18-45 years) with regular menstrual cycles who are willing to use non-hormonal contraception

Exclusion Criteria:

Conditions requiring the use of chronic pain therapy
Prophylactic use of analgesics to avoid endometriosis-related pain

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Montgomery	Alabama	United States	36116
2	Chandler	Arizona	United States	85225
3	Phoenix	Arizona	United States	85032
4	Phoenix	Arizona	United States	85035
5	Tucson	Arizona	United States	85712
6	San Francisco	California	United States	94115
7	Vista	California	United States	92083
8	Denver	Colorado	United States	80202
9	Denver	Colorado	United States	80206
10	New Britain	Connecticut	United States	06050
11	Clearwater	Florida	United States	33759
12	New Port Richey	Florida	United States	34652
13	Plantation	Florida	United States	33324
14	Venice	Florida	United States	34285
15	West Palm Beach	Florida	United States	33401
16	West Palm Beach	Florida	United States	33409
17	Marietta	Georgia	United States	30066
18	Idaho Falls	Idaho	United States	83404
19	Oak Brook	Illinois	United States	60523
20	Evansville	Indiana	United States	47714
21	Reno	Nevada	United States	89502
22	Lawrenceville	New Jersey	United States	08648
23	Durham	North Carolina	United States	27710
24	New Bern	North Carolina	United States	28562
25	Raleigh	North Carolina	United States	27612
26	Winston-Salem	North Carolina	United States	27103
27	Cleveland	Ohio	United States	44122
28	Miamisburg	Ohio	United States	45342
29	Oklahoma City	Oklahoma	United States	73112
30	Portland	Oregon	United States	97210
31	Abington	Pennsylvania	United States	19001
32	Lansdale	Pennsylvania	United States	19446
33	Philadelphia	Pennsylvania	United States	19107
34	Philadelphia	Pennsylvania	United States	19114
35	Pittsburgh	Pennsylvania	United States	15243
36	Columbia	South Carolina	United States	29201
37	Greenville	South Carolina	United States	29607
38	Bristol	Tennessee	United States	37620
39	Chattanooga	Tennessee	United States	37403
40	Memphis	Tennessee	United States	38119
41	Corpus Christi	Texas	United States	78414
42	San Antonio	Texas	United States	78229
43	West Valley City	Utah	United States	84120
44	Norfolk	Virginia	United States	23507
45	Richmond	Virginia	United States	23233
46	Richmond	Virginia	United States	23294
47	Virginia Beach	Virginia	United States	23456
48	Renton	Washington	United States	98055
49	Madison	Wisconsin	United States	53792
50	Randwick	New South Wales	Australia	2031
51	Sydney	New South Wales	Australia	200
52	Richmond	Victoria	Australia	3121
53	Nedlands	Western Australia	Australia	6009
54	Herestraat	Leuven	Belgium	3000
55	Calgary	Alberta	Canada	T2N 4L7
56	Vancouver	British Columbia	Canada	V6Z 1Y6
57	Winnipeg	Manitoba	Canada	R3A 1R9
58	Halifax	Nova Scotia	Canada	B3H 2N1
59	London	Ontario	Canada	N6A 4V2
60	Toronto	Ontario	Canada	M5B 1W8
61	Saskatoon	Saskatchewan	Canada	S7K 1N4
62	Hong Kong		Hong Kong
63	Cape Town	Capetown	South Africa	7925
64	Port Elizabeth	Eastern Cape	South Africa	6001
65	Roodepoort	Jgb Gauteng	South Africa	1724
66	Durban	KwaZulu Natal	South Africa	4320
67	Nottingham	Nottinghamshire	United Kingdom	NG7 2UH
68	Glasgow	Scotland	United Kingdom	G51 4TF
69	Sheffield	South Yorshire	United Kingdom	S10 2SF
70	Swindon	Wiltshire	United Kingdom	SN3 6BD

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager, For United Kingdom, ukmedinfo@wyeth.com
Principal Investigator: Trial Manager, For Australia and Hong Kong, medinfo@wyeth.com
Principal Investigator: Trial Manager, For South Africa, ZAFinfo@wyeth.com
Principal Investigator: Trial Manager, For Belgium, trials-BEL@wyeth.com
Principal Investigator: Trial Manager, For Canada, clintrialparticipation@wyeth.com