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Estradiol Patch for Obesity

Phase 4
Waitlist Available
Led By Nanette Santoro, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 1. Age 18-38 2. Regular menstrual cycles every 25-35 days 3. No use of reproductive hormones within the past 3 months 4. No use of medications interacting with reproductive hormones 5. Agreement to use reliable barrier contraception or to abstain from intercourse for the duration of the study 6. Normal thyroid stimulating hormone, prolactin and lipid profiles 7. No more than 4 hours of moderate to vigorous intensity exercise per week 8. No history of chronic disease impacting reproductive hormones 9. No history of diabetes 10. Nonsmoker 11. No personal history of venous thromboembolism or known thrombophilia 12. No contraindications to administration of estradiol 13. No history of estrogen dependent cancer 14. Negative pregnancy test
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to 7 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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.

Eligible Conditions
  • Obesity
  • Female Infertility

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to 7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Amount of Luteinizing hormone Surge
Secondary study objectives
Time of Luteinizing Hormone Peak

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Estradiol PatchExperimental Treatment1 Intervention
Transdermal estradiol patch
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estradiol Patches
1992
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,804 Previous Clinical Trials
2,822,123 Total Patients Enrolled
106 Trials studying Obesity
214,426 Patients Enrolled for Obesity
Colorado Clinical & Translational Sciences InstituteOTHER
20 Previous Clinical Trials
1,367 Total Patients Enrolled
3 Trials studying Obesity
82 Patients Enrolled for Obesity
Nanette Santoro, MDPrincipal InvestigatorUniversity of Colorado School of Medicine
18 Previous Clinical Trials
6,247 Total Patients Enrolled
4 Trials studying Obesity
161 Patients Enrolled for Obesity
~13 spots leftby Jun 2025
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