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Melatonin Effects on Luteinizing Hormone

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Scripps Health

Status and phase

Terminated
Phase 2
Phase 1

Conditions

Hot Flashes

Treatments

Drug: melatonin 0.5 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT00288262
03-101 (Scripps SOPRS #)
NIH M01 RR00833 (in part)

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

50 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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