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NCT01613131 · ClinicalTrials.gov registry record · NA
Mirena and Estrogen for Control of Perimenopause Symptoms and Ovulation Suppression
A NA study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 39
- Enrollment target
NCT01613131 is a NA study that has completed, run by University of Colorado, Denver. The registered enrollment target is 39 participants.
The verdict
NCT01613131, a NA study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
Study Summary
Hormonal treatment of perimenopausal women has frequently utilized oral contraceptive pills (OCPs). Because of their ability to suppress ovulation and establish cycle control, OCPs have become a popular option, and one that is FDA approved for use until menopause. However, use of OCPs in women in their 40's and 50's carries significant cardiovascular risks. Venous thromboembolism risk is 3-6 fold greater in OCP users, and the risk of myocardial infarction (MI) is approximately doubled in OCP users over the age of 40. This occurs at an age where the background population risk of MI begins to increase, such that the absolute number of cases rises substantially. Women with additional risk factors for cardiovascular disease have a much greater risk for MI (6-40-fold) in association with OCPs. There are also large subgroups of midlife women who are not candidates for OCP use, such a smokers and migraineurs. Moreover, the trend towards lower estrogen dosing with OCPs containing 20 micrograms of ethinyl estradiol has not led to a detectable decrease in thromboembolic risk. Because of their increased potential risks, it is appropriate to seek alternatives to OCPs and to explore lower doses of hormones to relieve perimenopausal symptoms that occur prior to a woman's final menses. Recent evidence indicates that the hypothalamic-pituitary axis of reproductively aging women is more susceptible to suppression by sex steroids that previously believed. It is possible that hormone doses as low as 50 micrograms of transdermal estradiol (TDE) can suppress the hypothalamic-pituitary axis of midlife women. It is also tempting to speculate that the low but measurable circulating doses of levonorgestrel that are present when a woman uses the Mirena intrauterine system (IUS) can contribute to or even independently suppress the hypothalamic-pituitary axis, and reduce the hormonal fluctuations that result in worsening of perimenopausal symptoms. The combination of low dose TDE plus Mirena
Interventions
- DRUG Estradiol
- DRUG Placebo Gel
- DRUG Mirena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01613131
The ClinicalTrials.gov registry entry for NCT01613131 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Estradiol is the first listed.
NCT01613131 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01613131 about?
NCT01613131 is a clinical study titled "Mirena and Estrogen for Control of Perimenopause Symptoms and Ovulation Suppression". Hormonal treatment of perimenopausal women has frequently utilized oral contraceptive pills (OCPs). Because of their ability to suppress ovulation and establish cycle control, OCPs have become a popular option, and one that is FDA approved for use until menopause. However, use of OCPs in women in th...
What is the current status of trial NCT01613131?
This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2012-04. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01613131?
The interventions under investigation include: Estradiol (DRUG), Placebo Gel (DRUG), Mirena (DRUG).
Who is sponsoring clinical trial NCT01613131?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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