Study of Leptin for the Treatment of Hypothalamic Amenorrhea
Condition: Amenorrhea
MeSH terms: Amenorrhea
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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.

      Part A is a Randomized, placebo-controlled 36-week study. Part B is an Optional open-label
      52-week study. There will also be an optional Reward Sub-study, including healthy controls,
      designed to investigate leptin's relation to reward processing by collecting participants'
      brain and behavioral responses to images (e.g., pictures of food vs. non-food). Brain
      responses will be collected and will also be assessed via functional Magnetic Resonance
      Imaging (fMRI).

      Comparison: Part A = leptin-treated group to placebo-treated group and Part B optional sub
      study = leptin-treated group to health controls
    

Intervention name(s): r-metHuLeptin; Oral Contraceptive Pills (OCPs); Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Starting dose: 0.08mg/kg once daily Subcutaneous injection.; Sprintec taken orally once daily.; placebo (no active medication)
Other intervention name(s): metreleptin; OCPs
Intervention MeSH terms: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: leptin; hypothalamic amenorrhea; exercise-induced amenorrhea; neuroendocrine function; bone metabolism