Phase 2a Randomized, Double-Blind Study of Oleoyl-Estrone in Male Morbidly Obese Adults - Full Text View

Purpose

Multi-center, multiple-dose, randomized, double-blind, three-arm, placebo-controlled study of fixed-dose repeated oral dosing for 30 days of 10 mg and 30 mg MP-101 and placebo in obese subjects.

Condition	Intervention	Phase
Obesity	Drug: oleoyl-estrone (MP-101)	Phase II

MedlinePlus related topics:

Obesity

Drug Information available for:

Estrone Estropipate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Phase 2a Randomized, Double-Blind, Placebo Controlled, Parallel Group, Safety and Efficacy Study of Oleoyl-Estrone (MP-101) in Male Obese Adults.

Further study details as provided by Manhattan Pharmaceuticals:

Primary Outcome Measures:

To evaluate the safety and tolerability

Secondary Outcome Measures:

To evaluate the preliminary efficacy

Estimated Enrollment:	24
Study Start Date:	October 2006

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject is willing and able to provide signed informed consent.
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 who have received any investigational medication within 3 months prior to administration of study drug
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449254

Locations


United States, New York
	St. Luke's-Roosevelt Hospital
	New York, New York, United States, 10025

United States, Texas
	Research Across America
	Dallas, Texas, United States, 75234

United States, Utah
	Jean Brown Research
	Salt Lake City, Utah, United States, 84124

Sponsors and Collaborators

Manhattan Pharmaceuticals

More Information

Study ID Numbers:	MAN-OE-US-04
First Received:	March 16, 2007
Last Updated:	June 4, 2007
ClinicalTrials.gov Identifier:	NCT00449254
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Nutrition Disorders

Overweight

Overnutrition

Oleoyl-estrone

Estrone

Additional relevant MeSH terms:

Anti-Obesity Agents

Estrogens

Therapeutic Uses

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Central Nervous System Agents

Hormones

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Manhattan Pharmaceuticals
Information provided by:	Manhattan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00449254