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Hormone Therapy
Estradiol Patches for Female Infertility
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
No use of reproductive hormones within the past 3 months
Age 18-38
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to 7 days
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved
Summary
"This trial will investigate whether obesity affects how the brain responds to hormones related to reproduction in women. The study will look at how obesity may lead to a decreased hormone response in the brain, potentially affecting the
Who is the study for?
This trial is for women who are dealing with obesity and infertility. Participants should have a body mass index (BMI) that classifies them as obese and be experiencing difficulties in conceiving. Specific details about inclusion or exclusion criteria were not provided, so interested individuals should contact the study organizers for more information.
What is being tested?
The trial is investigating how obesity affects the response to estradiol, a form of estrogen, at the brain level. It will look at whether overweight impacts hormone surges related to fertility using estradiol patches and testing their effect on hormone release in obese women.
What are the potential side effects?
While specific side effects are not listed here, generally, estradiol patches can cause skin irritation where applied, nausea, headache, breast tenderness or swelling; however individual experiences may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't used any hormonal birth control or hormone replacement therapy in the last 3 months.
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I am between 18 and 38 years old.
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I have never been diagnosed with diabetes.
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I have never had blood clots or a clotting disorder.
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I am not taking any medications that affect my hormones.
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I have never had a cancer that grows in response to estrogen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment to 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to 7 days
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
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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
1,810 Previous Clinical Trials
2,920,080 Total Patients Enrolled
Colorado Clinical & Translational Sciences InstituteOTHER
20 Previous Clinical Trials
1,367 Total Patients Enrolled
Nanette Santoro, MDPrincipal InvestigatorUniversity of Colorado School of Medicine
18 Previous Clinical Trials
5,959 Total Patients Enrolled