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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00973973 |
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Date of registration:
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07/09/2009 |
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Primary sponsor: |
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Public title:
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Efficacy and Safety Study of NBI-56418 Sodium in Subjects With Endometriosis
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Scientific title:
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-56418 Sodium in Subjects With Endometriosis |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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137 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00973973 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Laura Williams, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Abbott |
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Key inclusion & exclusion criteria
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Inclusion Criteria
- Be female, aged 18 to 49 years, inclusive.
- Have moderate to severe pelvic pain due to endometriosis.
- Have a history of regular menstrual cycles.
- Have been surgically (laparoscopy or laparotomy) diagnosed with endometriosis within
8 years of the start of screening.
- Have a Body Mass Index (BMI) of 18 to 36 kg/m2, inclusive.
- Agree to use two forms of non-hormonal contraception during the study.
Exclusion Criteria
- Are currently receiving GnRH agonist, a GnRH antagonist other than NBI-56418, or
danazol or have received any of these agents within 6 months of the start of
screening.
- Are currently receiving DMPA-SC or DMPA-IM or have received any of these agents
within 3 months of the start of screening.
- Are currently using hormonal contraception or other forms of hormonal therapy or
received such treatment within the last month.
- Have had surgery for endometriosis within the last month.
- Have had a hysterectomy or bilateral oophorectomy.
- Are using systemic steroids on a chronic or regular basis within 3 months.
- Have uterine fibroids =3 cm in diameter.
- Have pelvic pain that is not caused by endometriosis.
- Have unstable medical condition or chronic disease.
- Have been pregnant within the last six months.
- Currently breast feeding.
Age minimum:
18 Years
Age maximum:
49 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Endometriosis, Pain
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Intervention(s)
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Drug: NBI-56418
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Drug: Placebo
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Primary Outcome(s)
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Dysmenorrhea assessments
[Time Frame: Daily assessments over 8 weeks]
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dyspareunia assessments
[Time Frame: Daily assessments over 8 weeks]
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nonmenstrual pelvic pain assessments
[Time Frame: Daily assessments over 8 weeks]
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Secondary Outcome(s)
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Safety endpoint: Adverse Events
[Time Frame: 30 weeks]
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Safety endpoint: Clinical laboratory tests
[Time Frame: 30 weeks]
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Safety endpoint: electrocardiogram (ECG)
[Time Frame: 30 weeks]
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Safety endpoint: Physical examination
[Time Frame: 30 weeks]
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Safety endpoint: Vaginal bleeding
[Time Frame: 30 weeks]
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Safety endpoint: Vital signs
[Time Frame: 30 weeks]
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Secondary ID(s)
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NBI-56418-0901
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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