Melatonin Effects on Luteinizing Hormone

Study Overview
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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.

Official Title
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Melatonin Effects on Luteinizing Hormone

Conditions
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Hot Flashes

Intervention / Treatment
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* Drug: melatonin 0.5 mg


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: melatonin 0.5 mg|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hot flashes log |  |  | 
| Sleep log |  |  | 
| QIDS |  |  | 
| CESD |  |  | 
| Luteinizing hormone (urine) |  |  | 
| Luteinizing hormone (blood) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAFTEE inventory of symptoms and adverse effects |  |  | 
| Other adverse events |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hot flashes, melatonin, depression, sleep, luteinizing hormone, postmenopause