Safety and Efficacy Study of NBI-56418 in Endometriosis - Full Text View

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

Show 61 Study Locations

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 09, 2009