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NCT06264882 · ClinicalTrials.gov registry record · Phase 4
Cardiometabolic Consequences of the Loss of Ovarian Function
A Phase 4 study of Aging and Menopause, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06264882: Recruiting Phase 4 study of Aging and Menopause, sponsored by University of Colorado, Denver.
NCT06264882 is a Phase 4 study of Aging and Menopause that is actively recruiting participants, 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
NCT06264882, a Phase 4 study of Aging and Menopause, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
The menopause transition is associated with a decrease in artery health and an increased risk for weight gain in storing fat in the stomach area which may increase the risk for heart disease. The purpose of this research is to study how the decrease in estrogen at menopause changes artery health and fat gain, and risk of disease in women as they age. The first aim in this study will determine whether short term and long term low estrogen levels in premenopausal women decreases artery function and whether this is related to an increase in fat in the stomach area. The second aim will determine whether the changes in artery health and body fat are related to changes in a pathway that breaks down an important amino acid called tryptophan. This pathway is thought to play a role in regulating the aging process. Therefore, the investigators will determine whether the decrease in artery health and the increase in body fat in the stomach region with low estrogen is related to changes in this pathway in the blood, in vascular cells and fat tissue. Because estrogen levels fluctuate in premenopausal women, the investigators will use an approach (intervention) that controls estrogen levels to address these aims. The investigators will use a medication that is typically used to treat endometriosis or uterine fibroids to lower estrogen levels and an estrogen patch to increase estrogen in some women. Some women will receive a patch that has no estrogen (called a placebo patch). The intervention period will be 20 weeks. The study will provide us with new knowledge on how low estrogen with menopause affects artery health and fat gain estrogen.
Primary Outcome
Ultrasound measurements of brachial artery FMD will be performed in the morning under fasted conditions, and analyzed (Vascular Analysis Tools 5.5.1) according to guidelines. Baseline FMD will be assessed during early follicular phase of menstrual cycle. Blood pressure will be measured prior to the FMD. To confirm endothelial-specific effects of the intervention, the investigators will also measure endothelium-independent dilation as brachial artery dilation to sublingual nitroglycerine (0.4 mg)
Conditions Studied
Interventions
- DRUG Degarelix
- DRUG Transdermal Estradiol Patch
- DRUG Transdermal Placebo Patch
Study Locations (1)
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-06-01 |
| Est. Completion | 2028-08-31 |
| Phase | Phase 4 |
What NCT06264882 shows while recruiting
NCT06264882 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 4 conditions, with Aging appearing as the primary indexed condition, and to 3 interventions - of which Degarelix is the first listed.
NCT06264882 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT06264882 about?
NCT06264882 is a clinical study titled "Cardiometabolic Consequences of the Loss of Ovarian Function". The menopause transition is associated with a decrease in artery health and an increased risk for weight gain in storing fat in the stomach area which may increase the risk for heart disease. The purpose of this research is to study how the decrease in estrogen at menopause changes artery health and...
What is the current status of trial NCT06264882?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2024-06-01. Estimated completion is 2028-08-31.
What conditions does trial NCT06264882 study?
This clinical trial studies the following conditions: Aging, Menopause, Adiposity, Estrogen Deficiency.
What interventions are being tested in trial NCT06264882?
The interventions under investigation include: Degarelix (DRUG), Transdermal Estradiol Patch (DRUG), Transdermal Placebo Patch (DRUG).
Who is sponsoring clinical trial NCT06264882?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06264882 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 NCT06264882'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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