Status:
COMPLETED
Raising Insulin Sensitivity in Post Menopause
Lead Sponsor:
Pennington Biomedical Research Center
Conditions:
Menopause
Eligibility:
FEMALE
50-60 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to find out if a novel drug approved by the Food and Drug Administration \[Duavee™, Pfizer, Inc\] for treatment of postmenopausal symptoms (vaginal dryness and hot flashes...
Detailed Description
This study involves a screening process to see if you are eligible to participate followed by two 8-week treatment periods separated by an 8-week washout period. The two 8-week treatments will be with...
Eligibility Criteria
Inclusion
- Post-menopausal women (\<5y post last period)
- Age between 50-60y
- Symptomatic (hot flashes, vaginal dryness) or asymptomatic
- BMI 30-40 kg/m2
- Normal mammogram past 12 months
- Physician clearance (Ob/Gyn or PBRC)
Exclusion
- Amenorrhea other causes (excess androgen)
- Diabetes mellitus
- Medications: diabetes, antidepressant uncontrolled depression (2 months stability on SSRIs are fine), antipsychotics, oral steroids, weight loss drugs
- Tricyclic antidepressants (TCAs)
- ≤ 3 month washout of birth control pill, estrogen, and/or progestin
- Hysterectomy (total or partial)
- Contraindications to estrogen treatment
- Unable or unwilling to do an MRS
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2017
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02274571
Start Date
September 1 2015
End Date
April 11 2017
Last Update
June 4 2025
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808