Study of Leptin for the Treatment of Hypothalamic Amenorrhea
| Status: | Archived |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
Randomized, Double-blind, Placebo-controlled Trial of Human Recombinant Leptin (r-metHuLeptin) for the Treatment of Hypothalamic (Exercise-Induced) Amenorrhea
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 (exercise-induced) amenorrhea (HA) who are being treated with oral
contraceptive pills (OCPs), 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 (exercise-induced) amenorrhea may be the reason for
the lack of menstrual cycles, hormone abnormalities, and bone loss associated with this
condition.
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 HA 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 HA (i.e. no regular menstrual periods
due to low levels of pituitary hormones that regulate estrogen production from the ovary).
It will also investigate whether leptin replacement can be used as an adjunct to the current
standard of care for HA patients, i.e. OCPs.
Comparison: leptin-treated group to placebo-treated group
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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