Timing Estrogen After MenoPaUSe

Completed · Not applicable · Has a placebo group

Conditions studied: Insulin Resistance

In brief

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.

Key facts

Study ID

NCT01605071

Run by

University of Colorado, Denver

People needed

53

Starts

2011-09-01

Expected to finish

2017-01-01

Last updated by the study team

2021-03-01

Who can join

Age: 45 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Colorado Denver — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.