CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 29 enrolled
Drug / intervention
leuprolidedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01116401
NCT01116401Phase 4Completed
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Impact of Experimentally Induced Hot Flashes on Sleep and Mood Disturbance

Massachusetts General Hospital·interventional·Posted May 5, 2010·Updated Jan 23, 2018

In Brief

A Phase 4 clinical trial evaluating leuprolide for Menopause and 2 related conditions. Completed, enrolled 29 participants across 1 site.

Detailed Summary

We plan to enroll premenopausal women in a trial investigating the impact of hot flashes developed in response to an injection of a gonadotropin-releasing hormone agonist (GnRHa), leuprolide (brand name: Lupron), on sleep disruption and mood. This study is designed to mimic the menopause transition. We will collect data on sleep disruption and mood changes to assess their relationship to the development of hot flashes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenopause, Depression, Hot Flashes
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 5, 2010
Enrollment StartNov 3, 2009
Primary CompletionDec 29, 2011
Study CompletionJan 4, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16.2 years ago

Interventions

leuprolidedrug

Leuprolide acetate is a widely used GnRH agonist. In this protocol, leuprolide will be administered at a dose routinely used for treatment of endometriosis and uterine fibroids in women (one 3.75-mg intramuscular injection).