Endometriosis Trial: Study of NBI-56418 in Endometriosis
Summary
Seventy-two subjects will be randomized to one of three treatment groups: placebo (capsules that will look like the study drug), 75 mg and 150 mg NBI-56418 in a 1:1:1 ratio. Study drug will be administered once daily for 12 weeks. After the last dose at the end of Week 12, follow-up will continue every 4 weeks for 12 weeks.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Endometriosis
Intervention
NBI-56418 (GnRH antagonist)
Location
Arizona Wellness Center for Women
Phoenix
Arizona
United States
85032
Status
Completed
Source
Neurocrine Biosciences
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00109512
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Naloxone
A specific opiate antagonist that has no agonist activity. It is a competitive antagonist at mu, delta, and kappa opioid receptors.
Diprenorphine
A narcotic antagonist similar in action to NALOXONE. It is used to remobilize animals after ETORPHINE neuroleptanalgesia and is considered a specific antagonist to etorphine.
Endometriosis
A condition in which functional endometrial tissue is present outside the UTERUS. It is often confined to the PELVIS involving the OVARY, the ligaments, cul-de-sac, and the uterovesical peritoneum.
Pentazocine
The first mixed agonist-antagonist analgesic to be marketed. It is an agonist at the kappa and sigma opioid receptors and has a weak antagonist action at the mu receptor. (From AMA Drug Evaluations Annual, 1991, p97)
Norethynodrel
A synthetic progestational hormone with actions and uses similar to those of PROGESTERONE. It has been used in the treatment of functional uterine bleeding and endometriosis. As a contraceptive, it has usually been administered in combination with MESTRANOL.
Clinical Trials
An Efficacy and Safety Study of NBI-56418 in Endometriosis
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Efficacy and Safety Study in Endometriosis With NBI-56418; Placebo and Active Controlled
This study is designed to evaluate the safety and beneficial effects of NBI-56418 compared to placebo and leuprorelin (an approved endometriosis therapy) over a three month period followed...
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