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Melatonin Effects on Luteinizing Hormone

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00288262
First Posted: February 7, 2006
Last Update Posted: February 7, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of California, San Diego
Information provided by:
Scripps Health
  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 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Melatonin Effects on Luteinizing Hormone

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00288262     History of Changes
Other Study ID Numbers: 03-101 (Scripps SOPRS #)
NIH M01 RR00833 (in part)
First Submitted: January 30, 2006
First Posted: February 7, 2006
Last Update Posted: February 7, 2006
Last Verified: October 2005

Keywords provided by Scripps Health:
hot flashes
melatonin
depression
sleep
luteinizing hormone
postmenopause

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Hormones
Melatonin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Central Nervous System Depressants