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Hormone Therapy
Estradiol Patch for Menopause (LILAC Trial)
Phase 4
Recruiting
Led By Kerrie Moreau, PhD
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
Age criteria of 20-45 years
Premenopausal defined as normal menstrual cycle function defined as no more than 1 missed cycle in the previous year
Must not have
Preexisting or active cardiac, renal, or hepatic disease
History of venous thromboembolic event (VTE)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at 2 and 20 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
Summary
"This trial aims to study how the decrease in estrogen during menopause affects artery health and body fat distribution in women. The researchers will investigate whether low estrogen levels lead to decreased artery function and increased fat in
Who is the study for?
This trial is for premenopausal women who are experiencing the transition to menopause, which may affect their artery health and increase belly fat. Participants should be generally healthy but concerned about obesity, low estrogen levels due to aging or menopause.
What is being tested?
The study tests how estrogen affects artery function and abdominal fat gain in aging women. It involves a medication called Degarelix to lower estrogen levels, an Estradiol Patch to raise them in some participants, and a placebo patch with no active hormone for comparison over 20 weeks.
What are the potential side effects?
Possible side effects include skin irritation from patches, hormonal changes such as mood swings or hot flashes due to altering estrogen levels, and reactions at the injection site of Degarelix.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 20 and 45 years old.
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I am premenopausal with regular menstrual cycles, missing no more than 1 in the past year.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a heart, kidney, or liver condition.
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I have had a blood clot in my veins before.
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I have had breast cancer or another cancer that grows with estrogen.
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I have an ongoing infection.
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I have severe osteoporosis or very low bone mass.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and at 2 and 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at 2 and 20 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Brachial artery flow mediated dilation (FMD)
Secondary study objectives
Visceral fat area (VFA)
Other study objectives
Adipokines
Arterial Stiffness
Blood glucose
+17 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Degarelix plus transdermal placeboExperimental Treatment2 Interventions
At baseline \& 10 weeks: 80-mg subcutaneous injection of degarelix acetate plus Placebo transdermal patch (applied twice per week)
Group II: Degarelix plus transdermal estradiolExperimental Treatment2 Interventions
At baseline \& 10 weeks: 80-mg subcutaneous injection of degarelix acetate plus 0.075mg estradiol transdermal patch (applied twice per week)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Degarelix
2002
Completed Phase 3
~3730
Transdermal Placebo Patch
2012
N/A
~50
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,804 Previous Clinical Trials
28,194,799 Total Patients Enrolled
16 Trials studying Menopause
3,001 Patients Enrolled for Menopause
University of Colorado, DenverLead Sponsor
1,810 Previous Clinical Trials
2,920,000 Total Patients Enrolled
10 Trials studying Menopause
582 Patients Enrolled for Menopause
Kerrie Moreau, PhDPrincipal InvestigatorUniversity of Colorado Denver Anschutz Medical Campus
3 Previous Clinical Trials
372 Total Patients Enrolled
1 Trials studying Menopause
100 Patients Enrolled for Menopause