Understanding Experimentally Induced Hot Flushes
Condition: Hot Flashes
MeSH terms: Hot Flashes
Intervention: Leuprolide acetate
Intervention description: 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.
Intervention MeSH terms: Leuprolide
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Lupron; Premenopausal; Hot flashes

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