Prostate Cancer Clinical Trial
Understanding Experimentally Induced Hot Flushes
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Boston Massachusetts, 02114, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.