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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Understanding Experimentally Induced Hot Flushes

NCTNCT00455689 (opens ClinicalTrials.gov in a new tab)Other id2005P-001512
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
20 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
28 Nov 2005
Primary completion
24 Jul 2007
Completion
2 Sept 2007
First posted
4 Apr 2007 (estimated)
Last update posted
18 Sept 2018
Conditions
Hot Flashes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2005200620072008
  1. Ph 4

    Understanding Experimentally Induced Hot Flushes

    NCT00455689

    28 Nov 2005 to 2 Sept 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of the study is to examine the impact of hot flushes on sleep, mood, and well-being. The investigators will cause hot flushes by giving study participants the hormone medication, leuprolide (Lupron), which is a manufactured (artificial) hormone that makes the body think that it has reached menopause temporarily. Most women begin to have hot flushes within 4 weeks after taking leuprolide and resume menses 3 months later. The investigators will administer questionnaires to evaluate changes in sleep and mood over the course of the study.

Interventions

  • Leuprolide acetateDrug

Arms2

  • Experimental

    Developed hot flashes

    Subjects who developed hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)

  • Experimental

    Did not develop hot flashes

    Subjects who did not develop hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change in Objective Sleep Efficiency

    Time frame · baseline (before receiving intervention) and 4 weeks after receiving intervention

    Registry description

    Objective sleep efficiency was measured using actigraphy. Sleep efficiency (percent of time spent asleep between bedtime and wake time) was calculated and averaged over 2 consecutive nights both before and 4 weeks after receiving the intervention.

Secondary outcomes(1)

  1. Change in Subjective Sleep Quality

    Time frame · baseline (before receiving intervention) and 4 weeks after receiving intervention

    Registry description

    Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI; range 0-21, higher score indicates poorer quality sleep), which was administered both before and four weeks after receiving the intervention.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· baseline (before receiving intervention) and 4 weeks after receiving intervention

Percent Change in Objective Sleep Efficiency

GroupValue (percent change)
Developed Hot Flashes-2.6
Did Not Develop Hot Flashes4.2
Secondary and other outcome results(1)
Secondary outcomeMedian· baseline (before receiving intervention) and 4 weeks after receiving intervention

Change in Subjective Sleep Quality

GroupValue (units on a scale)
Developed Hot Flashes2.5
Did Not Develop Hot Flashes1.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
All Subjects20 subjects who all received one leuprolide injection0 / 200 / 2013 / 20

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2012

Metabolic activity in the insular cortex and hypothalamus predicts hot flashes: an FDG-PET study.

Joffe et al. 2012The Journal of clinical endocrinology and metabolismcited by 19

PMID 22723326PMC3791433DOI 10.1210/jc.2012-1413PUB-22723326

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Women 18-45 years old * Premenopausal * Willingness to use barrier methods of contraception during study and after completion of study until menses resume * Good general health Exclusion Criteria: * Pregnancy * Breastfeeding * Hot flushes * Hemoglobin at the screening visit less than 10 gm/dL * Abnormal liver function tests * Abnormal renal function tests * BMI \> 35 kg/m2 * Previously diagnosed osteoporosis or osteopenia * Psychiatric disorder involving mood, anxiety, psychotic disorder, current anorexia nervosa, or current alcohol or substance-use disorder * Previous severe depression * Evidence of suicidal or homicidal ideation * Sleep apnea, narcolepsy, or other diagnosed sleep disorder * Contraindication, hypersensitivity, or previous allergic reaction to GnRH agonists * Regular use of centrally active medications * Use of hormonal medications for at least 2 months * Use of ketoconazole, clomiphene citrate, or anabolic/androgenic steroids in the preceding 3 months * Renal insufficiency * Abnormal vaginal bleeding * History of thrombo-embolism or cardiovascular disease * History of congestive heart failure or other conditions requiring sodium restriction * History of spinal cord compression * Metastatic vertebral lesions * Memory disorders * Urinary tract obstruction * History of liver, kidney, pulmonary, or metabolic disease

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