Endometriosis Trial: Study of NBI-56418 in Endometriosis

NCT00109512 | Completed Phase 2

• 1 other identifier: NBI-56418-0501
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 15

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.

Conditions

Endometriosis

Keywords

endometriosis; pelvic pain; painful periods; dysmenorrhea; painful menstruation; GnRH; agonist; antagonist; menstrual pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Endometriosis Health Profile-5 (EHP-5)

  Every 4 weeks

• Visual Analog Scale (VAS) scores

  Every 4 weeks

• Number of Subjects with Adverse Events

  Up to 24 weeks

• Clinical Laboratory Tests

  Up to 24 weeks

• Vital Sign Measurements

  Up to 24 weeks

Study Arms (3)

placebo

PLACEBO COMPARATOR

Drug: placebo

NBI-56418 75 mg

EXPERIMENTAL

Drug: NBI-56418 (GnRH antagonist)

NBI-56418 150 mg

EXPERIMENTAL

Drug: NBI-56418 (GnRH antagonist)

Interventions

NBI-56418 (GnRH antagonist) DRUG

NBI-56418 150 mg; NBI-56418 75 mg

placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (15)

Site Reference ID/Investigator# 56266

Phoenix, Arizona, 85032, United States

Location

Site Reference ID/Investigator# 55210

San Diego, California, 92103, United States

Location

Site Reference ID/Investigator# 55214

San Ramon, California, 94566, United States

Location

Site Reference ID/Investigator# 56267

Clearwater, Florida, 33759, United States

Location

Site Reference ID/Investigator# 56270

Champaign, Illinois, 61820, United States

Location

Site Reference ID/Investigator# 56273

Chicago, Illinois, 60612, United States

Location

Site Reference ID/Investigator# 56269

Oak Brook, Illinois, 60523, United States

Location

Site Reference ID/Investigator# 56271

Peoria, Illinois, 61615, United States

Location

Site Reference ID/Investigator# 56272

Louisville, Kentucky, 40291, United States

Location

Site Reference ID/Investigator# 55213

Winston-Salem, North Carolina, 27103, United States

Location

Site Reference ID/Investigator# 55211

Arlington, Texas, 76012, United States

Location

Site Reference ID/Investigator# 56268

Sandy City, Utah, 84070, United States

Location

Site Reference ID/Investigator# 56274

Richmond, Virginia, 23294, United States

Location

Site Reference ID/Investigator# 55212

Virginia Beach, Virginia, 23451, United States

Location

Site Reference ID/Investigator# 56275

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Endometriosis; Pelvic Pain; Dysmenorrhea

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Pathologic Processes

Study Officials

• Laura Williams, MD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 28, 2005
• First Posted: April 29, 2005
• Study Start: April 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

US (15)