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Sponsors and Collaborators: |
Corcept Therapeutics Eli Lilly and Company |
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Information provided by: | Corcept Therapeutics |
ClinicalTrials.gov Identifier: | NCT00455442 |
This is a two-week study testing the efficacy and safety of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers by measuring changes in body weight and BMI.
Condition | Intervention | Phase |
---|---|---|
Weight-Gain Prevention |
Drug: Mifepristone |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Two-Week, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Mifepristone in the Prevention of Olanzapine-Induced Weight Gain in Healthy Male Volunteers |
Enrollment: | 57 |
Study Start Date: | March 2007 |
Study Completion Date: | July 2007 |
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | C-1073-200 |
Study First Received: | March 30, 2007 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00455442 |
Health Authority: | United States: Food and Drug Administration; India: Institutional Review Board |
Body Weight Signs and Symptoms Olanzapine Body Weight Changes |
Mifepristone Healthy Weight Gain |
Abortifacient Agents, Steroidal Contraceptives, Postcoital, Synthetic Contraceptive Agents Hormone Antagonists Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists |
Reproductive Control Agents Contraceptives, Postcoital Luteolytic Agents Pharmacologic Actions Therapeutic Uses Abortifacient Agents Menstruation-Inducing Agents Contraceptives, Oral, Synthetic |