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Sponsors and Collaborators: |
Beth Israel Deaconess Medical Center National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Center for Research Resources (NCRR) Amgen |
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Information provided by: | Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT00130117 |
The purpose of this study is to determine whether administration of an investigational medication called leptin (r-metHuLeptin) in replacement doses can improve bone health, reproductive function, hormone levels, immune function, and overall sense of well-being in women with hypothalamic amenorrhea, compared to placebo. Women with hypothalamic amenorrhea have low leptin levels. This study is based on the hypothesis that the relative leptin deficiency in women with hypothalamic amenorrhea may be the reason for the lack of menstrual cycles, hormone abnormalities, and bone loss associated with this condition.
Condition | Intervention | Phase |
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Amenorrhea |
Drug: r-metHuLeptin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Placebo-Controlled Trial of Human Recombinant Leptin (r-metHuLeptin) for the Treatment of Hypothalamic Amenorrhea |
Estimated Enrollment: | 34 |
Study Start Date: | August 2005 |
Leptin is a hormone secreted by fat cells under normal conditions and acts in the brain to regulate energy usage and hormone levels. Women with hypothalamic amenorrhea who do not have regular periods have low leptin levels and may also have other hormone abnormalities as well as loss of bone density (osteopenia or osteoporosis). This study will evaluate how leptin (a fat cell hormone that normally circulates in the blood) affects bone density, menstrual periods, hormone levels, bone metabolism (how bone forms and turns over), immune function (how well the body can fight infection), metabolic rate (how many calories are used at rest), and overall sense of well-being and appetite in women with hypothalamic amenorrhea (i.e. no regular menstrual periods due to low levels of pituitary hormones that regulate estrogen production from the ovary).
Comparison: leptin-treated group to placebo-treated group
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Chuanyun Gao, MD | (617) 667-8629 | gchuanyu@bidmc.harvard.edu |
Contact: Christos S Mantzoros | (617) 667-8630 | cmantzor@bidmc.harvard.edu |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center General Clinical Research Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Jean L Chan, MD 617-667-8624 jchan@bidmc.harvard.edu | |
Sub-Investigator: Jean L Chan, MD | |
Principal Investigator: Christos S Mantzoros, MD, DSc |
Principal Investigator: | Christos S Mantzoros, MD, DSc | Beth Israel Deaconess Medical Center, Harvard Medical School |
Study Director: | Jean L Chan, MD | Beth Israel Deaconess Medical Center, Harvard Medical School |
Study ID Numbers: | 2004P-000123 |
Study First Received: | August 11, 2005 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00130117 |
Health Authority: | United States: Food and Drug Administration |
leptin hypothalamic amenorrhea neuroendocrine function bone metabolism |
Menstruation Disturbances Amenorrhea |
Pathologic Processes |