Convergent Mechanisms Underlying Reprometabolic Syndrome in Women

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06686537
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 38 Years
Healthy Volunteers
Accepted

Interventions

  • Estradiol Patches — DRUG
    Estradiol patched will be worn for 7 days.

Study Details

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.

Key Dates

First listed
Nov 13, 2024
Start date
Feb 25, 2025
Status verified
Jul 2026
Primary completion
Oct 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Estradiol Patch- Normal Weight women
    Normal weight women (NWW) will wear a Transdermal estradiol patch for 7 days and collect urine to determine LH surge.
  • Experimental: Estradiol Patch- Women with high BMI
    Women with a BMI greater than 30 kg/m2 will wear a Transdermal estradiol patch for 7 days and collect urine to determine LH surge.

Primary Outcome Measure

Amount of Luteinizing hormone Surge [ Time Frame: From enrollment to the end of treatment is 7 days. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado School of MedicineAuroraColorado80045-
University of Colorado-School of MedicineAuroraColorado80045
Asma Giornazi, MS
[email protected]
303-724-5276

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By research site
University of Colorado School of Medicine· Aurora, COUniversity of Colorado-School of Medicine· Aurora, CO

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