Phase 2a Randomized, Double-Blind Study of Oleoyl-Estrone in Male Morbidly Obese Adults
NCT ID: NCT00449254
Last Updated: 2007-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
24 participants
INTERVENTIONAL
2006-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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oleoyl-estrone (MP-101)
Eligibility Criteria
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Inclusion Criteria
* Subject is a male and is between 18-60 years of age.
* Subject is obese as defined as a BMI of 40 - 55.
* Subject is reasonably healthy and have a reasonably acceptable medical history
* Subject has a stable weight for the past 30 days per subject report.
* Subject who has at least one factor of the metabolic
* Subject exhibits stable behavior patterns with regard to smoking and exercise
* Subject can read, speak and write the English language and agrees to follow study procedures.
Exclusion Criteria
* Subjects with confirmed positive results of UDS or Alcohol
* Subjects who are unwilling to return to the clinical research center on specified days during the treatment periods.
* Subjects who have taken exclusionary medication
* Subjects with any clinically significant laboratory abnormality or illness which, in the opinion of the Investigator, would contraindicate study participation
* Subjects who have a history of testing positive for Hepatitis B virus, Hepatitis C virus, or HIV.
* Subject has been involved in a formal or informal (self-imposed) diet regimen within the last 30 days.
* Subject has a confirmed diagnosis or history of cancer, with the exception of nonmelanoma skin cancer.
* Subject is otherwise unsuitable for the study, in the opinion of the investigator.
18 Years
60 Years
MALE
No
Sponsors
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Manhattan Pharmaceuticals
INDUSTRY
Locations
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St. Luke's-Roosevelt Hospital
New York, New York, United States
Research Across America
Dallas, Texas, United States
Jean Brown Research
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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MAN-OE-US-04
Identifier Type: -
Identifier Source: org_study_id