Timing Estrogen After MenoPaUSe (TEMPUS)
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ClinicalTrials.gov Identifier: NCT01605071 |
Recruitment Status
:
Completed
First Posted
: May 24, 2012
Last Update Posted
: April 4, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Insulin Resistance | Drug: Estradiol | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 55 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Other |
Official Title: | Time Past Menopause, Duration of Estrogen Deficiency, and Insulin Action |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | November 2015 |
Actual Study Completion Date : | January 2017 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Early Postmenopausal
Postmenopausal women within 6 years of last menses who never used estrogen-based hormone therapy
|
Drug: Estradiol
1 week of transdermal estradiol (0.15mg) 1 week of transdermal placebo Other Name: Climara
|
Active Comparator: Late Postmenopausal
Postmenopausal women more than 10 years since last menses who never used estrogen-based hormone therapy
|
Drug: Estradiol
1 week of transdermal estradiol (0.15mg) 1 week of transdermal placebo Other Name: Climara
|
- insulin-mediated glucose disposal rate (hyperinsulinemic-euglycemic clamp) [ Time Frame: after 1wk estradiol or placebo ]randomized order of testing, cross-over design
- fat and muscle estrogen receptor expression [ Time Frame: after 1wk estradiol or placebo ]randomized order of testing, cross-over design
- 24hr glycemic profile (continuous glucose monitoring) [ Time Frame: after 1wk estradiol or placebo ]randomized order of testing, cross-over design

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Ages Eligible for Study: | 45 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605071
United States, Colorado | |
University of Colorado Denver | |
Aurora, Colorado, United States, 80045 |
Principal Investigator: | Rachael E Van Pelt, PhD | University of Colorado, Denver |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT01605071 History of Changes |
Other Study ID Numbers: |
11-0788 R01DK088105 ( U.S. NIH Grant/Contract ) |
First Posted: | May 24, 2012 Key Record Dates |
Last Update Posted: | April 4, 2017 |
Last Verified: | March 2017 |
Keywords provided by University of Colorado, Denver:
menopause estrogen insulin sensitivity estrogen receptors |
Additional relevant MeSH terms:
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Estradiol Polyestradiol phosphate Estrogens Estradiol 3-benzoate |
Estradiol 17 beta-cypionate Estradiol valerate Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female |