NCT06686537

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
6mo left

Started Feb 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Feb 2025Dec 2026

First Submitted

Initial submission to the registry

November 11, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

February 25, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

1.6 years

First QC Date

November 11, 2024

Last Update Submit

April 30, 2025

Conditions

Infertility, FemaleObesity

Keywords

ObesityInfertilityHypothalamic-pituitary-ovarian axispituitary dysfunction

Outcome Measures

Primary Outcomes (1)

  • Amount of Luteinizing hormone Surge

    Urinary luteinizing hormone concentration in mIU/mg of Creatinine

    From enrollment to the end of treatment is 7 days.

Secondary Outcomes (1)

  • Time of Luteinizing Hormone Peak

    From enrollment to 7 days

Study Arms (2)

Estradiol Patch- Normal Weight women

EXPERIMENTAL

Normal weight women (NWW) will wear a Transdermal estradiol patch for 7 days and collect urine to determine LH surge.

Drug: Estradiol Patches

Estradiol Patch- Women with high BMI

EXPERIMENTAL

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.

Drug: Estradiol Patches

Interventions

Estradiol PatchesDRUG

Estradiol patched will be worn for 7 days.

Estradiol Patch- Normal Weight womenEstradiol Patch- Women with high BMI

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEligibility is limited to only female (assigned at birth) participants due to the requirement for menstruating females.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Has diabetes
  • Is a smoker
  • History of venous thromboembolism or known thrombophilia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

University of Colorado-School of Medicine

Aurora, Colorado, 80045, United States

RECRUITING

Related Publications (2)

  • Jain A, Polotsky AJ, Rochester D, Berga SL, Loucks T, Zeitlian G, Gibbs K, Polotsky HN, Feng S, Isaac B, Santoro N. Pulsatile luteinizing hormone amplitude and progesterone metabolite excretion are reduced in obese women. J Clin Endocrinol Metab. 2007 Jul;92(7):2468-73. doi: 10.1210/jc.2006-2274. Epub 2007 Apr 17.

    PMID: 17440019BACKGROUND

  • Rovner P, Keltz J, Allshouse A, Isaac B, Hickmon C, Lesh J, Chosich J, Santoro N. Induction of the LH Surge in Premenarchal Girls Confirms Early Maturation of the Hypothalamic-Pituitary-Ovarian Axis. Reprod Sci. 2018 Jan;25(1):33-38. doi: 10.1177/1933719117741377. Epub 2017 Nov 19.

    PMID: 29153058BACKGROUND

MeSH Terms

Conditions

Infertility, FemaleObesityInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nanette Santoro, MD

    University of Colorado School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Kuhn

CONTACT

303-724-5276Katherine.Kuhn@cuanshcutz.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2024

First Posted

November 13, 2024

Study Start

February 25, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)