This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

HomeBrowseAboutFAQs
Log In
Sign Up
Endometriosis

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

Sponsored by Duramed Research

About this trial

Last updated 11 years ago

Study ID

DR-DZL-201

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18-75 Years
18 to 45 Years
Female
Female

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 18 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status