Status:
COMPLETED
Understanding Experimentally Induced Hot Flushes
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Endocrine Research Society
Conditions:
Hot Flashes
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief 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, leuprolid...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 28 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00455689
Start Date
November 28 2005
End Date
September 2 2007
Last Update
September 18 2018
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114