Study of Leptin for the Treatment of Hypothalamic 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.
Drug: Oral Contraceptive Pills (OCPs)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||Randomized, Double-blind, Placebo-controlled Trial of Human Recombinant Leptin (r-metHuLeptin) for the Treatment of Hypothalamic (Exercise-Induced) Amenorrhea|
- the difference between the placebo and leptin treated groups in the change in bone mineral density (BMD) at the anteroposterior (AP) spine from baseline to 36 weeks [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
- hormone levels and bone markers [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
- immune function [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
- body composition (weight and body fat) [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
- total, radial, hip bone density [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
- resting metabolic rate [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
- overall sense of well-being, appetite and food intake [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
r-metHuLeptin administered subcutaneously.
Starting dose: 0.08mg/kg once daily Subcutaneous injection.Drug: Oral Contraceptive Pills (OCPs)
Sprintec taken orally once daily.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130117
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center General Clinical Research Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Christos S Mantzoros, MD, ScD||Beth Israel Deaconess Medical Center, Harvard Medical School|