Timing Estrogen After MenoPaUSe (NCT01605071) | Clinical Trial Compass
CompletedNot Applicable
Timing Estrogen After MenoPaUSe
United States53 participantsStarted 2011-09
Plain-language summary
The aim of the current study is to test whether the effect of estrogen on insulin metabolism depends on the timing of treatment relative to when a woman went through menopause. The investigators hypothesize that estrogen will improve insulin sensitivity in early postmenopausal women, but decrease insulin sensitivity in late postmenopausal women.
Who can participate
Age range45 Years – 70 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* aged 45-70 yr
* postmenopausal (no menses ≥12 mo or bilateral oophorectomy and FSH \>30 IU/L)
* ≤6yrs or ≥10yrs of menopause (last menses or oophorectomy)
* BMI \<30 kg/m2 and weight stable (±2kg in past 2mo)
* non-smokers
* sedentary to moderately active (\<3 days/wk of structured exercise)
* naïve to estrogen-based hormone therapies (previous use ≤6 months)
* CBC, CMP and TSH values within normal ranges specified by lab
Exclusion Criteria:
* underwent a partial hysterectomy (i.e., one or both ovaries left intact)
* underwent menopause (natural, chemical, or surgical) prior to age 45yr
* are between \>6yr and \<10yr of menopause (last menses or oophorectomy)
* previously used (\>6 mo) or are currently using any formulation of estrogen-based HT (e.g., oral Premarin, transdermal 17beta-estradiol, selective estrogen receptor modulators)
* have T2DM or are being treated with glucose-lowering/ insulin sensitizing medications
* have uncontrolled hypertension (SBP\>140 and/or DBP\>90 mmHg)
* have hypertriglyceridemia (\>400 mg/dL)
* have contraindications to estrogen therapy (history of venous thromboembolism, heart disease, myocardial infarction, hormone sensitive cancer)
* have contraindications to biopsies (severe anemia, blood clotting disorders)