NCT00288262

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2006

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2006

Completed
Last Updated

February 7, 2006

Status Verified

October 1, 2005

First QC Date

January 30, 2006

Last Update Submit

February 6, 2006

Conditions

Hot Flashes

Keywords

hot flashesmelatonindepressionsleepluteinizing hormonepostmenopause

Outcome Measures

Primary Outcomes (6)

  • Hot flashes log

  • Sleep log

  • QIDS

  • CESD

  • Luteinizing hormone (urine)

  • Luteinizing hormone (blood)

Secondary Outcomes (2)

  • SAFTEE inventory of symptoms and adverse effects

  • Other adverse events

Interventions

melatonin 0.5 mgDRUG

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal woman
  • Troubled by hot flashes

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scripps Clinic Sleep Center

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Hot FlashesDepression

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Daniel F Kripke, MD

    Scripps Clinic Sleep Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 30, 2006

First Posted

February 7, 2006

Study Start

June 1, 2004

Study Completion

February 1, 2005

Last Updated

February 7, 2006

Record last verified: 2005-10

Locations

US(1)