Study of Leptin for the Treatment of Hypothalamic Amenorrhea
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborators:
Amgen Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Center for Research Resources (NCRR) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)