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Melatonin Effects on Luteinizing Hormone

NCT ID: NCT00288262

Last Updated: 2006-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-02-28

Brief Summary

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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

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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.

Conditions

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Hot Flashes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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melatonin 0.5 mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role collaborator

Scripps Health

OTHER

Sponsor Role lead

Principal Investigators

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Daniel F Kripke, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Clinic Sleep Center

Locations

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Scripps Clinic Sleep Center

La Jolla, California, United States

Site Status

Countries

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United States

Other Identifiers

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NIH M01 RR00833 (in part)

Identifier Type: -

Identifier Source: secondary_id

03-101 (Scripps SOPRS #)

Identifier Type: -

Identifier Source: org_study_id