Status:
COMPLETED
Metabolic and Psychological Changes Associated With Menopause Among Women With HIV
Lead Sponsor:
Massachusetts General Hospital
Conditions:
HIV Infections
Menopause
Eligibility:
FEMALE
45-52 years
Brief Summary
This study will investigate the prevalence and extent of both metabolic and psychosocial changes associated with the menopause transition over 1 year among women with HIV compared to women without HIV...
Detailed Description
Treatment with combination antiretroviral therapy (ART) has resulted in substantial improvement in survival among women living with HIV in the United States, many of whom have entered or will soon ent...
Eligibility Criteria
Inclusion
- Females age 45 -52.
- Females in the perimenopausal transition characterized by the presence of abnormal menstrual function, defined as less than 3 periods in the past 3 months, 1 cycle \>60 days in length in the prior 6 months, or irregular menses in 2 or more cycles within the past 6 months. Women who have been amenorrheic for \>12 months will not be eligible. 3. Women with HIV must have previously documented HIV and be receiving a stable treatment regimen for \> 3 months.
Exclusion
- Use of estrogen, combination hormone replacement therapy, oral contraceptive pills/patches, Depo Provera, glucocorticoids, testosterone, growth hormone or other anabolic steroids within the past 6 months.
- Diabetes and current use of insulin, or medications known to affect glucose or insulin levels.
- Positive pregnancy test or recently pregnant within the past year or lactating.
- Presence of active cancers.
- Current use of bisphosphonates, or a diagnosis of Paget's disease or other illnesses known to affect bone (Use of calcium and Vitamin D will be permitted).
- Opportunistic infection within 3 months of study participation (HIV positive subjects).
- \-
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01142817
Start Date
June 1 2010
End Date
May 1 2013
Last Update
August 7 2013
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114