Safety and Efficacy Study of NBI-56418 in Endometriosis

Condition(s) targeted: Endometriosis

Intervention: NBI-56418 (Drug); depo-subQ provera 104 (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Neurocrine Biosciences

This study is designed to see how a research compound (NBI-56418) works compared to DMPA-SC (also known as depo-provera) in women with endometriosis and to see how both may affect bone mineral density.

Official title: A Phase II, Randomized, Double-Blind, Randomized, Active-Controlled Study to Assess the Safety and Efficacy of NBI-56418 in Subjects With Endometriosis

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Bone mineral density

Composite pelvic signs and symptoms score

Minimum age: 18 Years. Maximum age: 49 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Be female, aged 18 to 49 years, inclusive

- Have moderate to severe pelvic pain due to endometriosis

- Have been surgically (laparoscopy or laparotomy) diagnosed with endometriosis within

the last 7 years and have recurrent or persistent endometriosis symptoms

- Have regular menstrual cycle (23-33 day)

- Agree to use two forms of non-hormonal contraception during the study

Exclusion Criteria:

- Are currently receiving GnRH agonist, GnRH antagonist, DMPA-SC or DMPA-IM or have

received any of these agents within the last 12 months

- Are currently using hormonal contraception or other forms of hormonal therapy or

received such treatment within the last month

- Have had surgery for endometriosis within the last month

- Are currently smoking more than 20 cigarettes per week

- Are using systemic steroids on a chronic or regular basis within 3 months

- Have uterine fibroids or other pelvic lesions ≥5 cm in diameter

- Have pelvic pain that is not caused by endometriosis

- Have unstable medical condition or chronic disease

- Have been pregnant within the last year and is currently breast feeding

Enterprise, Alabama, United States

Tucson, Arizona, United States

Phoenix, Arizona, United States

San Diego, California, United States

San Ramon, California, United States

Los Angeles, California, United States

Burbank, California, United States

Denver, Colorado, United States

New London, Connecticut, United States

Boynton Beach, Florida, United States

Tampa, Florida, United States

Sarasota, Florida, United States

Clearwater, Florida, United States

Miami, Florida, United States

New Pt. Richey, Florida, United States

Decatur, Georgia, United States

Savannah, Georgia, United States

Boise, Idaho, United States

Coeur D Alene, Idaho, United States

Chicago, Illinois 60612, United States

Oak Brook, Illinois, United States

South Bend, Indiana, United States

Wichita, Kansas, United States

New Orleans, Louisiana, United States

Baltimore, Maryland, United States

Haverhill, Massachusetts, United States

Pawpaw, Michigan, United States

Saginaw, Michigan, United States

Chesterfield, Missouri, United States

Missoula, Montana, United States

Winston-Salem, North Carolina, United States

Bismark, North Dakota, United States

Fargo, North Dakota, United States

Jamestown, North Dakota, United States

Franklin, Ohio, United States

Columbus, Ohio, United States

Cleveland, Ohio, United States

Eugene, Oregon, United States

Portland, Oregon, United States

Medford, Oregon, United States

West Reading, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Erie, Pennsylvania, United States

Florence, South Carolina, United States

Greenville, South Carolina, United States

Columbia, South Carolina, United States

Hilton Head, South Carolina, United States

Watertown, South Dakota, United States

Houston, Texas, United States

San Antonio, Texas, United States

Dallas, Texas, United States

Fort Worth, Texas, United States

Webster, Texas, United States

Murray, Utah, United States

Sandy, Utah, United States

Richmond, Virginia, United States

Norfolk, Virginia, United States

Vancouver, Washington, United States

Seattle, Washington, United States

Tacoma, Washington, United States

LaCrosse, Wisconsin, United States

Click here for more information about this study.

Starting date: November 2006
Last updated: April 14, 2008