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Melatonin Effects on Luteinizing Hormone

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ClinicalTrials.gov Identifier: NCT00288262
Recruitment Status : Terminated
First Posted : February 7, 2006
Last Update Posted : February 7, 2006
Sponsor:
Collaborator:
University of California, San Diego
Information provided by:
Scripps Health

Tracking Information
First Submitted Date  ICMJE January 30, 2006
First Posted Date  ICMJE February 7, 2006
Last Update Posted Date February 7, 2006
Study Start Date  ICMJE June 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2006)
  • Hot flashes log
  • Sleep log
  • QIDS
  • CESD
  • Luteinizing hormone (urine)
  • Luteinizing hormone (blood)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2006)
  • SAFTEE inventory of symptoms and adverse effects
  • Other adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Melatonin Effects on Luteinizing Hormone
Official Title  ICMJE Melatonin Effects on Luteinizing Hormone
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Hot Flashes
Intervention  ICMJE Drug: melatonin 0.5 mg
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: February 6, 2006)
20
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE February 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00288262
Other Study ID Numbers  ICMJE 03-101 (Scripps SOPRS #)
NIH M01 RR00833 (in part)
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Scripps Health
Collaborators  ICMJE University of California, San Diego
Investigators  ICMJE
Principal Investigator: Daniel F Kripke, MD Scripps Clinic Sleep Center
PRS Account Scripps Health
Verification Date October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP