Trial Information

Summary: Randomized, Double-blind, Placebo-controlled Trial of Human Recombinant Leptin for the Treatment of Hypothalamic Amenorrhea

The purpose of this study is to determine whether administration of an investigational medication called leptin 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.

Inclusion Criteria:

• Hypothalamic amenorrhea of at least 6 months duration with low or normal LH and FSH, e.g. due to strenuous exercise or low weight
• Age 18-35 years old
• Body weight within +/- 15% of ideal body weight and stable > 6 months (no change > 5 lbs)
• Baseline leptin level < 4 ng/mL

Exclusion Criteria:

• Significant medical history that may affect the concentrations of the hormones to studied or ability to participate in the study (renal or hepatic disease, diagnosed diabetes mellitus, myocardial ischemia, malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix, malabsorption, alcoholism, drug abuse, or smoking, active eating disorder, depression or other psychiatric disease, anemia)
• Other endocrine causes of amenorrhea (hyperprolactinemia, hypothyroidism or hyperthyroidism, Cushing’s syndrome, congenital adrenal hyperplasia, polycystic ovarian syndrome, primary ovarian failure)
• On medications known to affect the hormones to be measured (glucocorticoids, anti-seizure medications, thyroid hormones, estrogen)
• Breast feeding, pregnant, or wanting to become pregnant during the next 6 months

If you would like to learn more about participating in this study, please send an e-mail message using the form below.