Melatonin Effects on Luteinizing Hormone

Phase 1

Terminated

• Conditions: Hot Flashes

• Registration Number: NCT00288262
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-06
• Study Completion: 2005-02
• Status Verified: 2005-10
• Study First Submitted: 2006-01-30
• Study First Submitted QC: 2006-02-06
• Last Update Submitted: 2006-02-06
• Study First Posted: 2006-02-07
• Last Update Posted: 2006-02-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hot flashes log
Sleep log
QIDS
CESD
Luteinizing hormone (urine)
Luteinizing hormone (blood)

Secondary Outcome Measures

Name	Time	Method
SAFTEE inventory of symptoms and adverse effects
Other adverse events

Trial Locations

Locations (1)

Scripps Clinic Sleep Center; 🇺🇸 La Jolla, California, United States