Melatonin Effects on Luteinizing Hormone
Primary Purpose
Hot Flashes
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
melatonin 0.5 mg
Sponsored by
About this trial
This is an interventional treatment trial for Hot Flashes focused on measuring hot flashes, melatonin, depression, sleep, luteinizing hormone, postmenopause
Eligibility Criteria
Inclusion Criteria: Postmenopausal woman Troubled by hot flashes Exclusion Criteria: Use of reproductive hormones other than continuous estrogen or progesterone hormone replacement Any acute illness Any anticipated changes of medication Anemia (hemoglobin <12) or poor veins Recent trans-time-zone jet travel, shift work, or irregular sleep habits Any neurological or pituitary disease
Sites / Locations
- Scripps Clinic Sleep Center
Outcomes
Primary Outcome Measures
Hot flashes log
Sleep log
QIDS
CESD
Luteinizing hormone (urine)
Luteinizing hormone (blood)
Secondary Outcome Measures
SAFTEE inventory of symptoms and adverse effects
Other adverse events
Full Information
NCT ID
NCT00288262
First Posted
January 30, 2006
Last Updated
February 6, 2006
Sponsor
Scripps Health
Collaborators
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT00288262
Brief Title
Melatonin Effects on Luteinizing Hormone
Official Title
Melatonin Effects on Luteinizing Hormone
Study Type
Interventional
2. Study Status
Record Verification Date
October 2005
Overall Recruitment Status
Terminated
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Scripps Health
Collaborators
University of California, San Diego
4. Oversight
5. Study Description
Brief Summary
In many mammals, the duration of the nocturnal melatonin elevation regulates seasonal changes in reproductive hormones such as luteinizing hormone (LH). Melatonin's effects on human reproductive endocrinology are uncertain. It is thought that the same hypothalamic pulse generator may both trigger the pulsatile release of GnRH and LH and also cause hot flashes. Thus, if melatonin suppressed this pulse generator in postmenopausal women, it might moderate hot flashes. This clinical trial tested the hypothesis that melatonin could suppress LH and relieve hot flashes.
Detailed Description
Twenty postmenopausal women troubled by hot flashes underwent one week of baseline observation followed by 4 weeks of a randomized controlled trial of melatonin or matched placebo. The three randomized treatments were melatonin 0.5 mg 2.5-3 hours before bedtime, melatonin 0.5 mg upon morning awakening, or placebo capsules. Twelve of the women were admitted to the GCRC at baseline and at the end of randomized treatment for 24-hour sampling of blood for LH. Morning urine samples were collected twice weekly to measure LH excretion. Subjective responses measured throughout baseline and treatment included sleep and hot flash logs, the CESD and QIDS depression self-ratings, and the SAFTEE physical symptom inventory.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes
Keywords
hot flashes, melatonin, depression, sleep, luteinizing hormone, postmenopause
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
melatonin 0.5 mg
Primary Outcome Measure Information:
Title
Hot flashes log
Title
Sleep log
Title
QIDS
Title
CESD
Title
Luteinizing hormone (urine)
Title
Luteinizing hormone (blood)
Secondary Outcome Measure Information:
Title
SAFTEE inventory of symptoms and adverse effects
Title
Other adverse events
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Postmenopausal woman
Troubled by hot flashes
Exclusion Criteria:
Use of reproductive hormones other than continuous estrogen or progesterone hormone replacement
Any acute illness
Any anticipated changes of medication
Anemia (hemoglobin <12) or poor veins Recent trans-time-zone jet travel, shift work, or irregular sleep habits Any neurological or pituitary disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel F Kripke, MD
Organizational Affiliation
Scripps Clinic Sleep Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Clinic Sleep Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Melatonin Effects on Luteinizing Hormone
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