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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
Scripps Health
About
Eligibility
Locations
Outcomes
Full info

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

50 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
January 30, 2006
Last Updated
February 6, 2006
Sponsor
Scripps Health
Collaborators
University of California, San Diego
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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

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Melatonin Effects on Luteinizing Hormone

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