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Completed

NCT Number: NCT00455689

Understanding Experimentally Induced Hot Flushes

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.

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Key information

Conditions

Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Leuprolide Acetate

Drug

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

Leuprolide is a widely used gonadotropin-releasing hormone agonist (GnRHa) that 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.

Other names: Lupron

Primary outcomes

  1. Percent Change in Objective Sleep Efficiency

    Time frame: 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.

Secondary outcomes

  1. Change in Subjective Sleep Quality

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Endocrine Research Society

Registry information

Official study title

Understanding Experimentally Induced Hot Flushes and Their Impact on Sleep and Mood

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Apr 4, 2007
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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