Melatonin Effects on Luteinizing Hormone

• ClinicalTrials.gov Identifier: NCT00288262
• Recruitment Status: Terminated
• First Posted: February 7, 2006
• Last Update Posted: February 7, 2006
• Sponsor: Scripps Health
• Collaborator: University of California, San Diego
• Information provided by: Scripps Health

Tracking Information

• First Submitted Date: January 30, 2006
• First Posted Date: February 7, 2006
• Last Update Posted Date: February 7, 2006
• Study Start Date: June 2004
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: February 6, 2006)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: February 6, 2006)

• SAFTEE inventory of symptoms and adverse effects
• Other adverse events

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Melatonin Effects on Luteinizing Hormone
• Official Title: Melatonin Effects on Luteinizing Hormone
• 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.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Hot Flashes
• Intervention: Drug: melatonin 0.5 mg
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Enrollment (submitted: February 6, 2006): 20
• Original Enrollment: Same as current
• Study Completion Date: February 2005
• Primary Completion Date: Not Provided

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 50 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00288262
• Other Study ID Numbers: 03-101 (Scripps SOPRS #); NIH M01 RR00833 (in part)
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Scripps Health
• Collaborators: University of California, San Diego

Investigators

• Principal Investigator: Daniel F Kripke, MD; Scripps Clinic Sleep Center

• PRS Account: Scripps Health
• Verification Date: October 2005