Endometriosis Trial: Study of NBI-56418 in Endometriosis

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT00109512

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

5.1

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with subjects randomized to one of three treatment groups, placebo, 75 mg and 150 mg in a 1:1:1 ratio. Study drug was administered once daily for 12 weeks. After the last dose at the end of Week 12, follow-up continued every 4 weeks for 12 weeks.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: NBI-56418 (GnRH antagonist) Drug: placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of NBI-56418 in Endometriosis

Study Start Date :

Apr 1, 2005

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Jun 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo	Drug: placebo
Experimental: NBI-56418 75 mg	Drug: NBI-56418 (GnRH antagonist)
Experimental: NBI-56418 150 mg	Drug: NBI-56418 (GnRH antagonist)

Arm

Intervention/Treatment

Placebo Comparator: placebo

Drug: placebo

Experimental: NBI-56418 75 mg

Drug: NBI-56418 (GnRH antagonist)

Experimental: NBI-56418 150 mg

Drug: NBI-56418 (GnRH antagonist)

Outcome Measures

Primary Outcome Measures

Total Composite Pelvic Signs and Symptom Scale (CPSSS) scores [Every 4 weeks]
This scale is used to assess the signs (pelvic tenderness and induration) and symptoms (nonmenstrual pelvic pain, dysmenorrhea and dyspareunia) associated with endometriosis.

Secondary Outcome Measures

Endometriosis Health Profile-5 (EHP-5) [Every 4 weeks]
The EHP-5 assesses quality of life.
Visual Analog Scale (VAS) scores [Every 4 weeks]
VAS measures endometriosis pain.
Number of Subjects with Adverse Events [Up to 24 weeks]
Clinical Laboratory Tests [Up to 24 weeks]
Vital Sign Measurements [Up to 24 weeks]
Physical Examinations [Up to 24 weeks]
Electrocardiogram (ECG) tracings [Up to 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria

Be female, aged 18 to 49 years, inclusive.
Have pelvic pain and dysmenorrhea resulting in a Composite Pelvic Sign and Symptoms Score (CPSSS) of ≥ 6.
Have had a diagnosis of endometriosis made following laparoscopic visualization of the disease within the last 5 years of the start of screening.
Have regular menstrual cycles (28 days ±5 days) for greater than or equal to 2 years. For the cycle that immediately precedes dosing, cycle length will be determined as part of the medical history.
Have a Body Mass Index between 18 and 30 kg/m2.
Agree to use two forms of non-hormonal contraception (unless sterilized by tubal ligation) for greater than or equal to 3 months prior to Screening through ovulation and return of menses after treatment.
Have a negative serum pregnancy test at Screening and a negative urine pregnancy test at prior to dosing at the beginning of Week 1.
Have a cervical smear negative for malignancy at Screening.
Be willing to comply with all study procedures and restrictions.
Be able to read, understand, and sign the ICF (informed consent form) before entering into the study.
Be willing to provide authorization for access to personal health information in conjunction with US Health Insurance Portability and Accountability Act (HIPAA).

Exclusion Criteria

Are currently receiving a GnRH agonist or GnRH antagonist, or have received any of these agents within 6 months of Screening.
Have been nonresponsive to GnRH agonist or antagonist therapy for the management of endometriosis.
Are currently receiving hormonal therapy including the oral contraceptive pill or have received any of these agents within 3 months of Screening.
Are on any concurrent medical treatment/medications or have had surgical or hormonal treatment other than oral contraceptives for endometriosis within 3 months of Screening.
Have uterine fibroids or any other pelvic lesions greater than or equal to 3 cm in diameter as verified by ultrasound.
Are currently breast-feeding an infant.
Are using any steroid preparation, taken by any route (e.g., oral, inhaled) on a chronic or regular basis within 3 months of Screening.
Have an unstable medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, or endocrine disease), or malignancy that could confound interpretation of the study outcomes.
Have chronic pelvic pain that is not caused by endometriosis.
Have any psychological disorder according to criteria indicated in the Diagnostics and Statistical Manual of Mental Disorders, 4th edition within one year before screening. Such disorders include, but are not limited to, alcohol and substance abuse/dependence.
Have a history of poor compliance in clinical research studies.
Have a medically significant illness in the 30 days before the beginning of Week 1.
Have a medically significant abnormality observed upon Screening or the beginning of Week 1 physical examination, or in any other baseline measurement. Findings outside the standard reference ranges will be jointly approved with NBI's (Neurocrine Biosciences) Medical Monitor before being considered eligible for the study.
Are using any investigational drug within 2 months of Screening.
Have a positive human immunodeficiency virus antibody (HIV Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCV-Ab) assay at Screening or have a history of a positive result.
Have an allergy, hypersensitivity, or intolerance to a GnRH agonist or antagonist.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 56266	Phoenix	Arizona	United States	85032
2	Site Reference ID/Investigator# 55210	San Diego	California	United States	92103
3	Site Reference ID/Investigator# 55214	San Ramon	California	United States	94566
4	Site Reference ID/Investigator# 56267	Clearwater	Florida	United States	33759
5	Site Reference ID/Investigator# 56270	Champaign	Illinois	United States	61820
6	Site Reference ID/Investigator# 56273	Chicago	Illinois	United States	60612
7	Site Reference ID/Investigator# 56269	Oak Brook	Illinois	United States	60523
8	Site Reference ID/Investigator# 56271	Peoria	Illinois	United States	61615
9	Site Reference ID/Investigator# 56272	Louisville	Kentucky	United States	40291
10	Site Reference ID/Investigator# 55213	Winston-Salem	North Carolina	United States	27103
11	Site Reference ID/Investigator# 55211	Arlington	Texas	United States	76012
12	Site Reference ID/Investigator# 56268	Sandy	Utah	United States	84070
13	Site Reference ID/Investigator# 56274	Richmond	Virginia	United States	23294
14	Site Reference ID/Investigator# 55212	Virginia Beach	Virginia	United States	23451
15	Site Reference ID/Investigator# 56275	Spokane	Washington	United States	99204