Melatonin Effects on Luteinizing Hormone - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hot Flashes	Drug: melatonin 0.5 mg	Phase I Phase II

Drug Information available for:

Melatonin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Melatonin Effects on Luteinizing Hormone

Further study details as provided by Scripps Health:

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

Estimated Enrollment:	20
Study Start Date:	June 2004
Estimated Study Completion Date:	February 2005

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.

Eligibility

Ages Eligible for Study:	50 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288262

Locations


United States, California
	Scripps Clinic Sleep Center
	La Jolla, California, United States, 92037

Sponsors and Collaborators

Scripps Health

University of California, San Diego

Investigators


Principal Investigator:	Daniel F Kripke, MD	Scripps Clinic Sleep Center

More Information

Study ID Numbers:	03-101 (Scripps SOPRS #), NIH M01 RR00833 (in part)
First Received:	January 30, 2006
Last Updated:	February 6, 2006
ClinicalTrials.gov Identifier:	NCT00288262
Health Authority:	United States: Institutional Review Board

Keywords provided by Scripps Health:

hot flashes

melatonin

depression

sleep

luteinizing hormone

postmenopause

Study placed in the following topic categories:

Signs and Symptoms

Depression

Hot Flashes

Melatonin

Depressive Disorder

Additional relevant MeSH terms:

Antioxidants

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Physiological Effects of Drugs

Central Nervous System Depressants

Protective Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2008

Sponsors and Collaborators:	Scripps Health University of California, San Diego
Information provided by:	Scripps Health
ClinicalTrials.gov Identifier:	NCT00288262