Evaluation of DR-2001 for the Management of Endometriosis-Related Pelvic Pain

Sponsor

Duramed Research (Industry)

Overall Status

Completed

CT.gov ID

NCT00117481

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a 3-arm, multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of DR-2001 in endometriosis-related symptoms, primarily nonmenstrual pelvic pain, over a 12-week treatment period.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: DR-2001a Drug: DR-2001b Other: Placebo	Phase 2

Detailed Description

This multicenter, double-blind, randomized, placebo-controlled study is designed to evaluate the ability of DR-2001 to produce beneficial changes in endometriosis-related symptoms, primarily nonmenstrual pelvic pain, over a 12-week treatment period. The overall study duration for each patient will be about 20 weeks.

Patients who meet all study entrance criteria will be randomly assigned to one of three treatment groups.

The change in endometriosis-related clinical symptoms will be assessed in two ways: through a combined physician/patient assessment and also with a patient self-assessment. Patients will undergo a gynecologic exam at each study visit.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate DR-2001 for the Management of Moderate to Severe Endometriosis-Related Nonmenstrual Pelvic Pain

Study Start Date :

Jun 1, 2005

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: DR-2001a DR-2001a administered vaginally each month
Experimental: 2	Drug: DR-2001b DR-2001b administered vaginally each month
Placebo Comparator: 3	Other: Placebo Placebo administered vaginally each month

Arm

Intervention/Treatment

Experimental: 1

Drug: DR-2001a

DR-2001a administered vaginally each month

Experimental: 2

Drug: DR-2001b

DR-2001b administered vaginally each month

Placebo Comparator: 3

Other: Placebo

Placebo administered vaginally each month

Outcome Measures

Primary Outcome Measures

Mean change in nonmenstrual pelvic pain at end of treatment [Baseline to Week 12/Early Withdrawal Visit]

Secondary Outcome Measures

Mean change in nonmenstrual pelvic pain and endometriosis-related symptoms [Weeks 4, 8 and 12]
Safety and tolerability of DR-2001 [Throughout study period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Surgically sterilized (patient or partner), willing to use condoms throughout the study, or otherwise not at risk for pregnancy
Diagnosis of endometriosis within the last 5 years
Moderate or severe nonmenstrual pelvic pain
Premenopausal
Not pregnant or breastfeeding
Regular (24-35 day) menstrual cycles for at least 2 months

Exclusion Criteria:

Undiagnosed abnormal genital bleeding
Any contraindication to the use of hormonal therapy
Prior surgery for endometriosis
GnRH analog therapy within 5 months
Use of estrogens and/or progestins within 2 months
Pain symptoms unrelated to endometriosis
Any contraindication to the use of vaginal delivery systems

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duramed Investigational Site	Enterprise	Alabama	United States	36330
2	Duramed Investigational Site	Montgomery	Alabama	United States	53717
3	Duramed Investigational Site	Phoenix	Arizona	United States	85032
4	Duramed Investigational Site	Tucson	Arizona	United States	85712
5	Duramed Investigational Site	Little Rock	Arkansas	United States	72205
6	Duramed Investigational Site	La Jolla	California	United States	92093
7	Duramed Investigational Site	San Diego	California	United States	92103
8	Duramed Investigational Site	Vista	California	United States	92083
9	Duramed Investigational Site	Colorado Springs	Colorado	United States	80909
10	Duramed Investigational Site	Clearwater	Florida	United States	33759
11	Duramed Investigational Site	Hudson	Florida	United States	34667
12	Duramed Investigational Site	Spring Hill	Florida	United States	34609
13	Duramed Investigational Site	Tampa	Florida	United States	33606
14	Duramed Investigational Site	West Palm Beach	Florida	United States	33409
15	Duramed Investigational Site	Decatur	Georgia	United States	30034
16	Duramed Investigational Site	Idaho Falls	Idaho	United States	83404
17	Duramed Investigational Site	Lagrange Park	Illinois	United States	60526
18	Duramed Investigational Site	Maywood	Illinois	United States	60153
19	Duramed Investigational Site	Oak Brook	Illinois	United States	60523
20	Duramed Investigational Site	Louisville	Kentucky	United States	40291
21	Duramed Investigational Site	Ann Arbor	Michigan	United States	48109
22	Duramed Investigational Site	Reno	Nevada	United States	89502
23	Duramed Investigational Site	Princeton	New Jersey	United States	08502
24	Duramed Investigational Site	Port Jefferson	New York	United States	11777
25	Duramed Investigational Site	Chapel Hill	North Carolina	United States	27599
26	Duramed Investigational Site	Morganton	North Carolina	United States	28655
27	Duramed Investigational Site	Winston-Salem	North Carolina	United States	27103
28	Duramed Investigational Site	Columbus	Ohio	United States	43210
29	Duramed Investigational Site	Dayton	Ohio	United States	45432
30	Duramed Investigational Site	Oklahoma City	Oklahoma	United States	73112
31	Duramed Investigational Site	Jenkintown	Pennsylvania	United States	36116
32	Duramed Investigational Site	Florence	South Carolina	United States	29501
33	Duramed Investigational Site	Jackson	Tennessee	United States	38305
34	Duramed Investigational Site	Memphis	Tennessee	United States	38120
35	Duramed Investigational Site	Austin	Texas	United States	78737
36	Duramed Investigational Site	Dallas	Texas	United States	75231
37	Duramed Investigational Site	San Antonio	Texas	United States	78229
38	Duramed Investigational Site	Pleasant Grove	Utah	United States	84062
39	Duramed Investigational Site	Sandy	Utah	United States	84070
40	Duramed Investigational Site	Norfolk	Virginia	United States	23607
41	Duramed Investigational Site	Virginia Beach	Virginia	United States	23456