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Melatonin Effects on Luteinizing Hormone

Melatonin Effects on Luteinizing Hormone

Status
Terminated
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00288262
Enrollment
20
Registered
2006-02-07
Start date
2004-06-30
Completion date
2005-02-28
Last updated
2006-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hot Flashes

Keywords

hot flashes, melatonin, depression, sleep, luteinizing hormone, postmenopause

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.

Interventions

Sponsors

University of California, San Diego
CollaboratorOTHER
Scripps Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Luteinizing hormone (blood)
CESD
Luteinizing hormone (urine)
Hot flashes log
Sleep log
QIDS

Secondary

MeasureTime frame
Other adverse events
SAFTEE inventory of symptoms and adverse effects

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026