A Phase II, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects with Endometriosis

• Conditions: Endometriosis; MedDRA version: 9.1Level: LLTClassification code 10014778Term: Endometriosis

• Registration Number: EUCTR2007-006474-28-PL
• Lead Sponsor: eurocrine Biosciences, INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

To participate in this study, subjects must:
• Be female, aged 18 to 45 years, inclusive.
• Have a total Composite Pelvic Signs and Symptoms Score (CPSSS)
of =6 at screening.
• Have a score of at least 2 for the dysmenorrhea CPSSS component and at least 1
for the nonmenstrual pelvic pain CPSSS component at baseline (Day 1, Week 1).
• Be at 2 to 5 days (inclusive) after the onset of menses prior to randomization
• Have had a diagnosis of endometriosis made following laparoscopic visualization of
the disease within 5 years of the start of screening with recurrent or persistent
symptoms.
• Have documented negative mammogram results within 12 months of screening if
over the age of 40 years.
• Have a history of regular spontaneous menstrual cycles. Assessment of cycle
duration should be based on observations in the absence of drugs or conditions that
are known to affect the cycle (e.g., oral contraceptives, leuprorelin, pregnancy)
• Have a spontaneous menstrual cycle of 28 days (±5 days) prior to randomization.
• Have a Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive.
• Agree to use two forms of nonhormonal contraception (e.g. condom and spermicide)
during the study (from the signing of the consent until the final study visit [end of
Week 30 or early termination]).
• Have a negative urine pregnancy test at screening and prior to dosing (at baseline)
at the beginning of Week 1.
• Have a minimum of 7 days of e-Diary data entries prior to randomization.
• Be willing to comply with all study procedures and restrictions.
• Be able to read and understand the Patient Information Sheet (PIS), and sign the
consent before entering into the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects will be excluded from the study if they:
• Were administered a GnRH agonist, GnRH antagonist, danazol, or have received
any of these agents within 6 months of the start of screening.
• Were administered subcutaneous medroxyprogesterone acetate (DMPA-SC) or i.m.
medroxyprogesterone acetate (DMPA-IM), or have received either of these agents
within 3 months of the start of screening.
• Have been nonresponsive to GnRH agonist or antagonist therapy for the
management of endometriosis.
• Are currently using hormonal contraception (for endometriosis or contraception) or
other forms of hormonal therapy for endometriosis or have received such therapy
within 1 month of the start of screening.
• Have had diagnostic laparoscopy or surgical intervention for endometriosis within
1 month of the start of screening.
• Have had a hysterectomy or oopherectomy.
• Have had prior treatment with NBI-56418.
• Have uterine fibroids =3 cm in diameter as determined by transvaginal ultrasound at
screening.
• Have any of the following abnormal cervical smear results at screening (based on
the 2001 Bethesda System [Solomon et al., 2002]):
- Atypical squamous cells of undetermined significance (ASC-US) present,
and human papilloma virus (HPV) reflex testing is positive for high risk
types or the testing outcome is unknown
- High-grade squamous intraepithelial lesion (HSIL) present
- Adenocarcinoma in situ (AIS) / malignant cells present
• Have BMD with either lumbar spine or femur T-scores below -1.5 at screening as
determined by the central DXA facility or have a history of pathologic or compression
fractures.
• Have been pregnant within 6 months of the start of screening.
• Are currently breastfeeding.
• Are using systemic steroids on a chronic or regular basis within 3 months of the start
of screening.
• Have a chronic, unstable endocrine abnormality causing dysregulation of the
hypothalamic-pituitary-gonadal axis that leads to ovarian dysfunction.
• Have an unstable medical condition or chronic disease (including history of
neurological [including cognitive], psychological, hepatic, renal, cardiovascular, GI,
or pulmonary disease), irritable bowel syndrome, interstitial cystitis, or malignancy
that could confound interpretation of the study outcomes.
• Have chronic pelvic pain that is not caused by endometriosis (e.g., uterine fibroids).
• 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 clinically significant abnormality based on assessments at screening or the
beginning of Week 1.
• Are using any investigational drug within 2 months of the start 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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified