Melatonin Effects on Luteinizing Hormone

Hot Flashes Clinical Trial

Official title:

Melatonin Effects on Luteinizing Hormone

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00288262
• Other study ID #: 03-101 (Scripps SOPRS #)
• Secondary ID: NIH M01 RR00833
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: January 30, 2006
• Last updated: February 6, 2006
• Start date: June 2004
• Est. completion date: February 2005

Study information

• Verified date: October 2005
• Source: Scripps Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hot Flashes

Intervention

Drug:
• melatonin 0.5 mg

Locations

Country	Name	City	State
United States	Scripps Clinic Sleep Center	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
Scripps Health	University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hot flashes log
Primary	Sleep log
Primary	QIDS
Primary	CESD
Primary	Luteinizing hormone (urine)
Primary	Luteinizing hormone (blood)
Secondary	SAFTEE inventory of symptoms and adverse effects
Secondary	Other adverse events