NCT06686537 · University of Colorado, Denver
Convergent Mechanisms Underlying Reprometabolic Syndrome in Women
What this study is about
Dr. Nanette Santoro proposes to test the specific question that obesity results in abnormal estradiol response at the level of the pituitary and hypothalamus. This will be shown in diminished pituitary sensitivity to gonadorelin releasing hormone with a reduced estradiol induced luteinizing hormone surge in obese women.
View original scientific description
Dr. Nanette Santoro proposes to test the specific question that obesity results in abnormal estradiol response at the level of the pituitary and hypothalamus. This will be shown in diminished pituitary sensitivity to gonadorelin releasing hormone with a reduced estradiol induced luteinizing hormone surge in obese women.
Interventions
DRUG
Estradiol Patches
Estradiol patched will be worn for 7 days.
Primary outcome measures
Amount of Luteinizing hormone Surge
Time frame: From enrollment to the end of treatment is 7 days.
Urinary luteinizing hormone concentration in mIU/mg of Creatinine
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Regular menstrual cycles every 25-35 days
- No use of reproductive hormones within the past 3 months
- No use of medications interacting with reproductive hormones
- Agreement to use reliable barrier contraception or to abstain from intercourse for the duration of the study
- Normal thyroid stimulating hormone, prolactin and lipid profiles
- No more than 4 hours of moderate to vigorous intensity exercise per week
- No history of chronic disease impacting reproductive hormones
- No contraindications to administration of estradiol
- No history of estrogen dependent cancer
- Negative pregnancy test
Exclusion criteria
- Has diabetes
- Is a smoker
- History of venous thromboembolism or known thrombophilia
Where
- Aurora, Colorado
Collaborators
Colorado Clinical & Translational Sciences Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2025 · Source of record for eligibility and locations