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| Sponsor: | Manhattan Pharmaceuticals |
|---|---|
| Information provided by: | Manhattan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00449202 |
Purpose
The purpose of this study is to evaluate the safety, preliminary efficacy, and pharmacokinetics of two 14-day cycles of escalating oral doses of MP 101 in 100 obese adult subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: oleoyl-estrone (MP 101) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase 2a Randomized, Double-Blind, Placebo Controlled, Parallel Group, Safety and Efficacy Study of Two 14 Day Cycles of Oral Doses of Oleoyl-Estrone (MP-101) in Obese Adult Subjects |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Louisiana | |
| Pennington Biomedical Research | |
| Baton Rouge, Louisiana, United States, 70808 | |
| United States, Utah | |
| Jean Brown Research | |
| Salt Lake City, Utah, United States, 84124 | |
| Switzerland | |
| Swiss Pharma Contract | |
| Basel, Switzerland | |
More Information
| ClinicalTrials.gov Identifier: | NCT00449202 History of Changes |
| Other Study ID Numbers: | MAN-OE-OS-03 |
| Study First Received: | March 16, 2007 |
| Last Updated: | March 16, 2007 |
| Health Authority: | United States: Food and Drug Administration Switzerland: Swissmedic |
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Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Estrone Estropipate Oleoyl-estrone Estrogens |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents Reproductive Control Agents Therapeutic Uses Anti-Obesity Agents Central Nervous System Agents |