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| Descriptive Information Fields | |||||
| Brief Title † | Amino Acid Therapy for Hot Flashes in Postmenopausal Women | ||||
| Official Title † | Amino Acid Therapy for Hot Flashes/Postmenopausal Women | ||||
| Brief Summary | The purpose of this study is to determine the safety, tolerability, and effectiveness of the amino acid L-isoleucine in the treatment of hot flashes in postmenopausal women. |
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| Detailed Description | Hot flashes affect approximately 75% of postmenopausal women. Although hormone replacement therapy (HRT) is highly effective in reducing hot flashes, long-term HRT is associated with increased rates of breast cancer and heart disease. Safe, effective, and well-tolerated hot flash therapies are needed. The amino acids L-methionine and L-isoleucine have produced reductions in hot flash frequency. However, long-term L-methionine therapy may increase cardiovascular risks. This study will evaluate the short-term effects of L-isoleucine therapy. Data from this study will be used to conduct long-term studies in the future. Participants in this study will be randomly assigned to receive one of two different L-isoleucine doses for 2 weeks. Clinic visits will be made at baseline, Week 1, and Week 10. Participants will record the frequency and severity of their hot flashes in a diary. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Uncontrolled, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Hot Flashes | ||||
| Intervention † | Drug: L-norleucine | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 15 | ||||
| Start Date † | October 2003 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | |||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00081952 | ||||
| Organization ID | K23 AT001709-01 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Verification Date | March 2006 | ||||
| First Received Date † | April 27, 2004 | ||||
| Last Updated Date | August 17, 2006 | ||||