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Therapeutic Areas: Obstetrics/Gynecology
Disease Category: Menstrual Disorders

Trial Information

Role of leptin in the reproductive system, neuroendocrine function, and bone metabolism in hypothalamic amenorrhea and amenorrheic women athletes

The purpose of this study is to determine how leptin, a hormone made by the fat cells of the body, affects the menstrual cycle, hormone levels, and bone metabolism in women who stop having regular menstrual cycles (i.e. have amenorrhea) due to exercise or central factors not related to ovarian failure. Women with this condition tend to have low leptin levels. They may also have other hormonal abnormalities and are at increased risk for developing osteoporosis (bone loss) at an early age and stress fractures. This study will involve administering leptin in order to restore leptin levels to the normal range in order to see whether menstrual cycles can be restored to normal.

This study will last 2 to 4 months (8 to 16 visits), depending on when subjects respond to the leptin treatment, including 2 inpatient overnight stays with the rest being outpatient visits. The exact dates are flexible. Subjects will be compensated up to $1500. Additional benefits include free hormonal tests and bone density & body composition measurements.

Inclusion Criteria:

• Age 18 to 35 years old
• Amenorrhea (no menstrual cycles) x 6 months
• Stable weight (weight change < 5 lb/6 months)
• Exercise : running > 20 miles/week or equivalent
• Otherwise healthy
• Not on hormones or can discontinue for the study
• Should be able to come to Boston for weekly visits

Exclusion Criteria:

• Illness which may affect hormone levels
• Eating disorders or depression
• Abnormal thyroid function or prolactin levels
• Planning to become pregnant within the next few months

Jean L. Chan, MD
Beth Israel Deaconess Medical Center
Division of Endocrinology & Metabolism
330 Brookline Ave, ST 816
Boston, MA 02215
Phone: 617-667-8624
Fax: 617-667-8634
EMail: jchan@caregroup.harvard.edu

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