COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Melatonin Effects on Luteinizing Hormone

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

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.

Condition or disease Intervention/treatment Phase
Hot Flashes Drug: melatonin 0.5 mg Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Melatonin Effects on Luteinizing Hormone
Study Start Date : June 2004
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Primary Outcome Measures :
  1. Hot flashes log
  2. Sleep log
  3. QIDS
  4. CESD
  5. Luteinizing hormone (urine)
  6. Luteinizing hormone (blood)

Secondary Outcome Measures :
  1. SAFTEE inventory of symptoms and adverse effects
  2. Other adverse events

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00288262

Layout table for location information
United States, California
Scripps Clinic Sleep Center
La Jolla, California, United States, 92037
Sponsors and Collaborators
Scripps Health
University of California, San Diego
Layout table for investigator information
Principal Investigator: Daniel F Kripke, MD Scripps Clinic Sleep Center
Layout table for additonal information Identifier: NCT00288262    
Other Study ID Numbers: 03-101 (Scripps SOPRS #)
NIH M01 RR00833 (in part)
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: February 7, 2006
Last Verified: October 2005
Keywords provided by Scripps Health:
hot flashes
luteinizing hormone
Additional relevant MeSH terms:
Layout table for MeSH terms
Hot Flashes
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants