Understanding Experimentally Induced Hot Flushes
| Status: | Completed |
|---|---|
| Conditions: | Hot Flash |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 9/20/2018 |
| Start Date: | November 28, 2005 |
| End Date: | September 2, 2007 |
Understanding Experimentally Induced Hot Flushes and Their Impact on Sleep and Mood
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.
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.
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
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