Understanding Experimentally Induced Hot Flushes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Hadine Joffe, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00455689
First received: April 2, 2007
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

The purpose of the study is to examine the impact of hot flushes on sleep, mood, and well-being. Hot flushes (or "hot flashes") are a feeling of being overheated, and often are followed by heavy sweating, skin becoming red and hot, and discomfort. Sometimes hot flushes are followed by chills. Some women experience a rapid heart rate. Hot flushes that happen at night are called night sweats, and they may interfere with sleep.

The investigators will cause hot flushes by giving study participants a hormone medication called leuprolide (Lupron). Hormones are chemicals that are naturally produced in the body. Leuprolide is a manufactured (artificial) hormone that will make the body think that it has reached menopause temporarily. Most women begin to have hot flushes within 4 weeks after taking leuprolide.

The investigators will also evaluate changes in sleep, mood, and feelings of well-being over the course of the study. The investigators will use questionnaires to measure these changes.


Condition Intervention Phase
Hot Flashes
Drug: Leuprolide acetate (Lupron)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Understanding Experimentally Induced Hot Flushes

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To examine the impact of hot flushes on sleep, mood, and well-being. [ Time Frame: Baseline and post-treatment (4 weeks after GnRH agonist) ] [ Designated as safety issue: No ]
    Experimentally induced hot flushes will correlate with impairment of sleep and mood.


Secondary Outcome Measures:
  • To describe the hormonal dynamics after administration of a gonadotropin-releasing hormone agonist that are associated with the development of hot flushes. [ Time Frame: Baseline and post-treatment (4 weeks after GnRH agonist) ] [ Designated as safety issue: No ]
    Changes in reproductive hormones after administration of a gonadotropin-releasing hormone will differ between those who do and do not develop hot flushes.


Enrollment: 33
Study Start Date: November 2005
Estimated Study Completion Date: October 2012
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Leuprolide Depot (GnRH agonist) Drug: Leuprolide acetate (Lupron)

Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection

Leuprolide is a widely used GnRH agonist that is manufactured by TAP Pharmaceutical Products. Leuprolide is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women.


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  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women 18-45 years old
  • Premenopausal, defined as regular month menstrual cycles (every 25-35-days) for the past 6 months and corroborated by a mid-luteal phase progesterone of > 3 ng/ml
  • Willingness to use barrier methods of contraception during study and after completion of study until menses resume
  • Good general health with normal hemoglobin, prolactin, TSH, liver function tests (SGOT, SGPT, bilirubin) and renal function tests (BUN, creatinine, alkaline phosphatase)

Exclusion Criteria:

  • Pregnancy, confirmed by serum HCG at screening visit and also by additional serum HCG testing conducted at the 3rd visit when GnRH agonist is given and in the 24 hours prior to each of the PET scans.
  • Breastfeeding
  • Hot flushes, as determined by skin-conductance monitor measurement and hot flush diary obtained after screening visit and before initiation of study medications
  • Hemoglobin at the screening visit less than 10 gm/dL
  • Abnormal liver function tests (SGOT, SGPT, or bilirubin > 2.5 times the upper limit of normal)
  • Abnormal renal function tests (BUN or creatinine > 2 times the upper limit of normal)
  • BMI > 35 kg/m2
  • Previously diagnosed osteoporosis or osteopenia
  • Psychiatric disorder involving mood (current major depression, current dysthymia, bipolar disorder) anxiety (current panic disorder, current obsessive compulsive disorder), psychotic disorder, current anorexia nervosa, or current alcohol or substance-use disorder, as determined by administration of the Patient Health Questionnaire (PHQ) or a score >16 on the Montgomery-Åsberg Depression Rating Scale (MADRS) indicating significant depression symptoms at the screening study visit. If the PHQ suggests one of these psychiatric disorders, the Structured Clinical Interview for Diagnosis-IV (SCID)48 will be administered to ensure that potential study participants do not have one of these psychiatric disorders. Previous severe depression, as characterized by psychotic symptoms or inpatient psychiatric hospitalization for a suicide attempt in the 5 years prior to study enrollment
  • Previous severe depression, as characterized by psychotic symptoms or inpatient psychiatric hospitalization for a suicide attempt in the 5 years prior to study enrollment
  • Evidence of suicidal or homicidal ideation, as determined by PHQ and MADRS at screening visit
  • Sleep apnea, narcolepsy, or other diagnosed sleep disorder, as determined by clinical interview in conjunction with the Sleep Disorders Questionnaire (55, 56) administered at screening visit
  • Contraindication, hypersensitivity, or previous allergic reaction to GnRH agonists
  • Regular use of centrally active medications (antidepressants, anxiolytics, hypnotics, anticonvulsants) for at least one month
  • 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 that may put subject at risk when treated with study medication.
  • Contraindication to PET or MRI imaging, such as cardiac pacemaker, implanted cardiac defibrillator, brain aneurysm clips, cochlear implant, ocular foreign body, shrapnel and/or prior history of allergic reaction to dyes used with scans.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00455689

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Hadine Joffe, MD
Investigators
Principal Investigator: Hadine Joffe, M.D., M.Sc. Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hadine Joffe, MD, Director of Research at the Center for Women's Mental Health, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00455689     History of Changes
Other Study ID Numbers: 2005P-001512
Study First Received: April 2, 2007
Last Updated: April 25, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Lupron
Premenopausal
Hot flashes
PET
MRI

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 19, 2014