Endometriosis Trial: Study of NBI-56418 in Endometriosis

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109512
• Other study ID #: NBI-56418-0501
• Status: Completed
• Phase: Phase 2
• First received: April 28, 2005
• Last updated: February 21, 2012
• Start date: April 2005
• Est. completion date: June 2006

Study information

• Verified date: February 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• NBI-56418 (GnRH antagonist)

• placebo

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 55211	Arlington	Texas
United States	Site Reference ID/Investigator# 56270	Champaign	Illinois
United States	Site Reference ID/Investigator# 56273	Chicago	Illinois
United States	Site Reference ID/Investigator# 56267	Clearwater	Florida
United States	Site Reference ID/Investigator# 56272	Louisville	Kentucky
United States	Site Reference ID/Investigator# 56269	Oak Brook	Illinois
United States	Site Reference ID/Investigator# 56271	Peoria	Illinois
United States	Site Reference ID/Investigator# 56266	Phoenix	Arizona
United States	Site Reference ID/Investigator# 56274	Richmond	Virginia
United States	Site Reference ID/Investigator# 55210	San Diego	California
United States	Site Reference ID/Investigator# 55214	San Ramon	California
United States	Site Reference ID/Investigator# 56268	Sandy	Utah
United States	Site Reference ID/Investigator# 56275	Spokane	Washington
United States	Site Reference ID/Investigator# 55212	Virginia Beach	Virginia
United States	Site Reference ID/Investigator# 55213	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Composite Pelvic Signs and Symptom Scale (CPSSS) scores	This scale is used to assess the signs (pelvic tenderness and induration) and symptoms (nonmenstrual pelvic pain, dysmenorrhea and dyspareunia) associated with endometriosis.	Every 4 weeks	No
Secondary	Endometriosis Health Profile-5 (EHP-5)	The EHP-5 assesses quality of life.	Every 4 weeks	No
Secondary	Visual Analog Scale (VAS) scores	VAS measures endometriosis pain.	Every 4 weeks	No
Secondary	Number of Subjects with Adverse Events		Up to 24 weeks	Yes
Secondary	Clinical Laboratory Tests		Up to 24 weeks	Yes
Secondary	Vital Sign Measurements		Up to 24 weeks	Yes
Secondary	Physical Examinations		Up to 24 weeks	Yes
Secondary	Electrocardiogram (ECG) tracings		Up to 24 weeks	Yes