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Safety and Efficacy Study of NBI-56418 in Endometriosis (PETAL)
This study has been completed.
First Received: February 16, 2007   Last Updated: September 28, 2009   History of Changes
Sponsor: Neurocrine Biosciences
Information provided by: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT00437658
  Purpose

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.


Condition Intervention Phase
Endometriosis
 Drug: NBI-56418
Drug: depo-subQ provera 104
 Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Endometriosis Minerals
Drug Information available for: Medroxyprogesterone 17-acetate Medroxyprogesterone
U.S. FDA Resources

Further study details as provided by Neurocrine Biosciences:

Primary Outcome Measures:
  • Bone mineral density [ Time Frame: Screening, 3 mo., 6 mo., 12 mo., 18 mo. ]
  • Composite pelvic signs and symptoms score [ Time Frame: monthly ]

Estimated Enrollment: 240
Study Start Date: November 2006
Study Completion Date: May 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437658

  Hide Study Locations
Locations
United States, Alabama
Enterprise, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
Phoenix, Arizona, United States
United States, California
Burbank, California, United States
San Ramon, California, United States
Los Angeles, California, United States
San Diego, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Connecticut
New London, Connecticut, United States
United States, Florida
Boynton Beach, Florida, United States
Tampa, Florida, United States
New Pt. Richey, Florida, United States
Clearwater, Florida, United States
Miami, Florida, United States
Sarasota, Florida, United States
United States, Georgia
Decatur, Georgia, United States
Savannah, Georgia, United States
United States, Idaho
Boise, Idaho, United States
Coeur D Alene, Idaho, United States
United States, Illinois
Chicago, Illinois, United States, 60612
Oak Brook, Illinois, United States
United States, Indiana
South Bend, Indiana, United States
United States, Kansas
Wichita, Kansas, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Haverhill, Massachusetts, United States
United States, Michigan
Pawpaw, Michigan, United States
Saginaw, Michigan, United States
United States, Missouri
Chesterfield, Missouri, United States
United States, Montana
Missoula, Montana, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, North Dakota
Bismark, North Dakota, United States
Fargo, North Dakota, United States
Jamestown, North Dakota, United States
United States, Ohio
Franklin, Ohio, United States
Columbus, Ohio, United States
Cleveland, Ohio, United States
United States, Oregon
Eugene, Oregon, United States
Portland, Oregon, United States
Medford, Oregon, United States
United States, Pennsylvania
West Reading, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Erie, Pennsylvania, United States
United States, South Carolina
Florence, South Carolina, United States
Greenville, South Carolina, United States
Columbia, South Carolina, United States
Hilton Head, South Carolina, United States
United States, South Dakota
Watertown, South Dakota, United States
United States, Texas
Houston, Texas, United States
San Antonio, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Webster, Texas, United States
United States, Utah
Murray, Utah, United States
Sandy, Utah, United States
United States, Virginia
Richmond, Virginia, United States
Norfolk, Virginia, United States
United States, Washington
Vancouver, Washington, United States
Seattle, Washington, United States
Tacoma, Washington, United States
United States, Wisconsin
LaCrosse, Wisconsin, United States
Sponsors and Collaborators
Neurocrine Biosciences
  More Information

Additional Information:
Click here for more information about this study.  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: NBI-56418-0603
Study First Received: February 16, 2007
Last Updated: September 28, 2009
ClinicalTrials.gov Identifier: NCT00437658     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Medroxyprogesterone 17-Acetate
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Endometriosis
 Reproductive Control Agents
Contraceptive Agents, Male
Pharmacologic Actions
Genital Diseases, Female
Therapeutic Uses
Contraceptives, Oral, Synthetic
Medroxyprogesterone

ClinicalTrials.gov processed this record on November 30, 2009



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