Melatonin Effects on Luteinizing Hormone

This study has been terminated.
Sponsor:
Collaborator:
University of California, San Diego
Information provided by:
Scripps Health
ClinicalTrials.gov Identifier:
NCT00288262
First received: January 30, 2006
Last updated: February 6, 2006
Last verified: October 2005
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

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

No publications provided

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

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
Pharmacologic Actions
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on April 16, 2014