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

Sponsored by:	Neurocrine Biosciences
Information provided by:	Neurocrine Biosciences
ClinicalTrials.gov Identifier:	NCT00619866

Purpose

This study is designed to see how a research compound (NBI- 56418) works compared to placebo (also known as a sugar pill) in women with endometriosis and to see the effect, if any, on bone mineral density.

Condition	Intervention	Phase
Endometriosis Pain	Drug: NBI-56418 Drug: placebo	Phase II

MedlinePlus related topics: Endometriosis Minerals Pelvic Pain

Drug Information available for: Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects With Endometriosis

Further study details as provided by Neurocrine Biosciences:

Primary Outcome Measures:

dysmenorrhea and nonmenstrual pelvic pain assessments [ Time Frame: Daily assessments over 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Bone Mineral Density [ Time Frame: Week 12, Week 24, and Week 48 (if needed) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	December 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental NBI-56418 - 150 mg tablet dose level	Drug: NBI-56418 150 mg tablet
2: Experimental NBI-56418 - 250 mg tablet dose level	Drug: NBI-56418 250 mg tablet
3: Placebo Comparator Placebo to match	Drug: placebo placebo tablet to match NBI-56418

Detailed Description:

This is a Phase II, multicenter, randomized, double-blind, placebo-controlled parallel-group study to assess the efficacy and safety of NBI-56418 at two dose levels (150 mg and 250 mg) administered once daily for up to 6 months. Approximately 150 subjects will be randomized (1:1:1) to one of the following treatment groups for the first 12 weeks of dosing: 150 mg NBI-56418 q.d.; 250 mg NBI-56418 q.d; or placebo q.d. Following 12 weeks of dosing, subjects will continue in the study for an additional 12 weeks; subjects randomized to NBI-56418 will continue to receive their assigned dose and subjects randomized to placebo will be re-randomized to receive one of the two doses of NBI-56418 (150 mg or 250 mg) for 12 weeks in a double-blind fashion. Blinding will be achieved using a double-dummy design. Six weeks after the last dose of study drug at the end of Week 24, a follow-up visit will be performed (end of Week 30). Subjects whose BMD, as measured by dual energy X-ray absorptiometry (DXA), at the end of Week 24 has decreased more than 3% from screening will be required to have an additional DXA scan at 6 months posttreatment.

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) diagnosed with endometriosis within the last 8 years and have recurrent or persistent endometriosis symptoms
Have regular menstrual cycle
Have a Body Mass Index (BMI) of 18 to 36 kg/m2, inclusive
Agree to use two forms of non-hormonal contraception during the study

Exclusion Criteria:

Are currently receiving GnRH agonist or GnRH antagonist or have received any of these agents within 6 months of the start of screening
Are currently receiving DMPA-SC or DMPA-IM or have received any of these agents within 3 months of the start of screening
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
Have had a hysterectomy or bilateral oophorectomy
Are using systemic steroids on a chronic or regular basis within 3 months
Have uterine fibroids ≥3 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 six months
Currently breast feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619866

Show 38 Study Locations

Sponsors and Collaborators

Neurocrine Biosciences

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Neurocrine Biosciences ( Robert Imani, MD, PhD/Medical Director )
Study ID Numbers:	NBI-56418-0702
Study First Received:	January 24, 2008
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00619866
Health Authority:	United States: Food and Drug Administration

Keywords provided by Neurocrine Biosciences:

endometriosis
pelvic pain
NBI-56418
bone mineral density
estradiol

Study placed in the following topic categories:

Genital Diseases, Female
Pelvic Pain
Estradiol 3-benzoate
Estradiol valerate
Endometriosis

Pain
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Estradiol

ClinicalTrials.gov processed this record on January 16, 2009