Clinical trial NCT00109512: Endometriosis Trial: Study of NBI-56418 in Endometriosis
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of NBI-56418 in Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: endometriosis
pelvic pain
painful periods
dysmenorrhea
painful menstruation
GnRH
agonist
antagonist
menstrual pain
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-04-29
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total Composite Pelvic Signs and Symptom Scale (CPSSS) scores
timeFrame: Every 4 weeks
Secondary outcomes:
measure: Endometriosis Health Profile-5 (EHP-5)
timeFrame: Every 4 weeks
measure: Visual Analog Scale (VAS) scores
timeFrame: Every 4 weeks
measure: Number of Subjects with Adverse Events
timeFrame: Up to 24 weeks
measure: Clinical Laboratory Tests
timeFrame: Up to 24 weeks
measure: Vital Sign Measurements
timeFrame: Up to 24 weeks
measure: Physical Examinations
timeFrame: Up to 24 weeks
measure: Electrocardiogram (ECG) tracings
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Site Reference ID/Investigator# 56266
state: Arizona
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 55210
state: California
city: San Ramon
country: United States
facility: Site Reference ID/Investigator# 55214
state: California
city: Clearwater
country: United States
facility: Site Reference ID/Investigator# 56267
state: Florida
city: Champaign
country: United States
facility: Site Reference ID/Investigator# 56270
state: Illinois
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 56273
state: Illinois
city: Oak Brook
country: United States
facility: Site Reference ID/Investigator# 56269
state: Illinois
city: Peoria
country: United States
facility: Site Reference ID/Investigator# 56271
state: Illinois
city: Louisville
country: United States
facility: Site Reference ID/Investigator# 56272
state: Kentucky
city: Winston-Salem
country: United States
facility: Site Reference ID/Investigator# 55213
state: North Carolina
city: Arlington
country: United States
facility: Site Reference ID/Investigator# 55211
state: Texas
city: Sandy
country: United States
facility: Site Reference ID/Investigator# 56268
state: Utah
city: Richmond
country: United States
facility: Site Reference ID/Investigator# 56274
state: Virginia
city: Virginia Beach
country: United States
facility: Site Reference ID/Investigator# 55212
state: Virginia
city: Spokane
country: United States
facility: Site Reference ID/Investigator# 56275
state: Washington
Study officials:
affiliation: Abbott
name: Laura Williams, MD
role: STUDY_DIRECTOR
References: