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NCT02042196 · ClinicalTrials.gov registry record · Early Phase 1
Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women
A Early Phase 1 study of Aging and Menopause, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT02042196: Completed Early Phase 1 study of Aging and Menopause, sponsored by University of Colorado, Denver.
NCT02042196 is a Early Phase 1 study of Aging and Menopause that has completed, run by University of Colorado, Denver. The registered enrollment target is 100 participants, below the 2,194-participant average among 262 other Aging trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02042196, a Early Phase 1 study of Aging and Menopause, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
As women get older and go through menopause, levels of the female reproductive hormone estradiol decrease to low levels. Also with aging, the functioning of the arteries declines. Over time this vascular dysfunction can lead to health problems such as high blood pressure and heart disease. This study is being done to help determine what causes arteries to become unhealthy in postmenopausal women, who have low levels of the female reproductive hormone estradiol. In this study we will test whether low levels of tetrahydrobiopterin (BH4), a natural substance in the body that can cause the arteries to expand, explains why arteries become unhealthy in women with low levels of estradiol. To answer this question, we will study how vascular function changes with a medication that causes a short-term increase in BH4 levels when estradiol is lowered with a medication, compared to when estradiol is normal. We will also determine whether the administration of the antioxidant vitamin C, along with the medication to increase BH4 levels, will normalize vascular health in perimenopausal and postmenopausal women, and in women who have their estradiol levels lowered.
Interventions
- DRUG Placebo
- DRUG KUVAN
- DRUG Cetrotide
- DRUG Climara
- DRUG Placebo transdermal patch
Study Locations (1)
Colorado
- University of Colorado Denver - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2013-12 |
| Est. Completion | 2016-05-02 |
| Phase | Early Phase 1 |
What the finished NCT02042196 record still lists
NCT02042196 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 2,194-participant average among 262 other Aging trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Aging appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT02042196 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT02042196 about?
NCT02042196 is a clinical study titled "Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women". As women get older and go through menopause, levels of the female reproductive hormone estradiol decrease to low levels. Also with aging, the functioning of the arteries declines. Over time this vascular dysfunction can lead to health problems such as high blood pressure and heart disease. This stud...
What is the current status of trial NCT02042196?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 100 participants. The study started on 2013-12. Estimated completion is 2016-05-02.
What conditions does trial NCT02042196 study?
This clinical trial studies the following conditions: Aging, Menopause.
What interventions are being tested in trial NCT02042196?
The interventions under investigation include: Placebo (DRUG), KUVAN (DRUG), Cetrotide (DRUG), Climara (DRUG), Placebo transdermal patch (DRUG).
Who is sponsoring clinical trial NCT02042196?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02042196 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02042196's enrollment target sits among peer trials
100 87th of 262 higher than 166 of 262 other Aging trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aging trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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