Recruiting
Phase 2

Estradiol Response

Sponsor:

University of Colorado, Denver

Code:

NCT06686537

Conditions

Infertility, Female

Obesity

Eligibility Criteria

Sex: Female

Age: 18 - 38

Healthy Volunteers: Accepted

Interventions

Estradiol Patches

Study Details

Brief summary:

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.

Conditions

Infertility, Female

Obesity

Study ID

NCT06686537

Start date

Feb 25, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 38

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 18-38
  • 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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Estradiol Patches

Estradiol patched will be worn for 7 days.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Carrie Hsu

303-724-5276Carire.Hsu@cuanschutz.edu

Asma Giornazi

asma.giornazi@cuanschutz.edu

Locations

University of Colorado School of Medicine

Recruiting

Aurora, Colorado, United States, 80045

University of Colorado-School of Medicine

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Asma Giornazi, MS

303-724-5276Asma.Giornazi@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • Obesity
  • Infertility
  • Hypothalamic-pituitary-ovarian axis
  • pituitary dysfunction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-07-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.