Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130117
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2005-08-11
Brief Title:
Study of Leptin for the Treatment of Hypothalamic Amenorrhea
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Randomized Double-blind Placebo-controlled Trial of Human Recombinant Leptin r-metHuLeptin for the Treatment of Hypothalamic Exercise-Induced Amenorrhea
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 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 ie 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 leptins relation to reward processing by collecting participants brain and behavioral responses to images eg 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
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 leptins relation to reward processing by collecting participants brain and behavioral responses to images eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5M01RR001032-32 | NIH | None | httpsreporternihgovquickSearch5M01RR001032-32 |
| 1R34HD048526-01 | NIH | None | None |