NCT00455689

Understanding Experimentally Induced Hot Flushes

Completed Phase 4 Results posted Last updated 18 September 2018

What this trial tests

Phase 4 trial testing Leuprolide acetate in Hot Flashes in 20 participants. Completed in 2 September 2007.

Timeline

28 November 2005

Primary endpoint
24 July 2007

2 September 2007

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	20
Start date	28 November 2005
Primary completion	24 July 2007
Estimated completion	2 September 2007
Sites	1 location across United States

Drugs / interventions tested

• Leuprolide acetate (leuprolide-acetate) — full drug profile →

Conditions studied

• Hot Flashes — all drugs for Hot Flashes →

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 45, female only, with Hot Flashes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change in Objective Sleep Efficiency Primary · baseline (before receiving intervention) and 4 weeks after receiving intervention

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.

Group	Value	95% CI
Developed Hot Flashes	-2.6	-10.2 – -0.9
Did Not Develop Hot Flashes	4.2	0.8 – 7.5

Change in Subjective Sleep Quality Secondary · baseline (before receiving intervention) and 4 weeks after receiving intervention

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.

Group	Value	95% CI
Developed Hot Flashes	2.5	1.0 – 4.0
Did Not Develop Hot Flashes	1.0	1.0 – 2.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Subjects were monitored for 3 months following GnRHa administration. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

All Subjects

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (9 terms — click to expand)

Reaction	System	All Subjects
Fatigue	General disorders	—
Headache	Nervous system disorders	—
Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	—
Acne	Skin and subcutaneous tissue disorders	—
Bloating	Gastrointestinal disorders	—
malodorous urine	Renal and urinary disorders	—
Irritability	Psychiatric disorders	—
Increased libido	General disorders	—
Edema	Vascular disorders	—

Data from ClinicalTrials.gov NCT00455689 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Objective sleep interruption and reproductive hormone dynamics in the menstrual cycle.
   Sharkey KM, Crawford SL, Kim S, Joffe H. · · 2014 · cited 41× · PMID 24841109 · DOI 10.1016/j.sleep.2014.02.003
2. Metabolic activity in the insular cortex and hypothalamus predicts hot flashes: an FDG-PET study.
   Joffe H, Deckersbach T, Lin NU, Makris N, et al · · 2012 · cited 18× · PMID 22723326 · DOI 10.1210/jc.2012-1413