Clinical trial NCT00455689: Understanding Experimentally Induced Hot Flushes
Official title: Understanding Experimentally Induced Hot Flushes and Their Impact on Sleep and Mood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hot Flashes
Keywords: Lupron
Premenopausal
Hot flashes
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Endocrine Research Society
First posted: 2007-04-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent Change in Objective Sleep Efficiency
timeFrame: baseline (before receiving intervention) and 4 weeks after receiving intervention
Secondary outcomes:
measure: Change in Subjective Sleep Quality
timeFrame: baseline (before receiving intervention) and 4 weeks after receiving intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Hadine Joffe, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joffe H, Deckersbach T, Lin NU, Makris N, Skaar TC, Rauch SL, Dougherty DD, Hall JE. Metabolic activity in the insular cortex and hypothalamus predicts hot flashes: an FDG-PET study. J Clin Endocrinol Metab. 2012 Sep;97(9):3207-15. doi: 10.1210/jc.2012-1413. Epub 2012 Jun 20.