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Hormone Therapy

Degarelix plus transdermal estradiol for Menopause (LILAC Trial)

Phase 4

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and at 2 and 20 weeks

Awards & highlights

LILAC Trial 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.Check my eligibility

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.See study design

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.

LILAC Trial Eligibility Criteria

Inclusion Criteria

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

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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.

LILAC Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at 2 and 20 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Brachial artery flow mediated dilation (FMD)

Secondary outcome measures

Visceral fat area (VFA)

Other outcome measures

Adipokines

Arterial Stiffness

Blood glucose

+17 more

LILAC 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

Transdermal Placebo Patch

2012

N/A

~50

Degarelix

2002

Completed Phase 3

~3600

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,672 Previous Clinical Trials

28,018,563 Total Patients Enrolled

16 Trials studying Menopause

3,113 Patients Enrolled for Menopause

University of Colorado, DenverLead Sponsor

1,735 Previous Clinical Trials

2,149,071 Total Patients Enrolled

10 Trials studying Menopause

613 Patients Enrolled for Menopause

Kerrie Moreau, PhDPrincipal InvestigatorUniversity of Colorado Denver Anschutz Medical Campus

3 Previous Clinical Trials

529 Total Patients Enrolled

1 Trials studying Menopause

100 Patients Enrolled for Menopause

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process for this study open to individuals aged 55 and above?

"Eligible participants for this research must be aged between 20 and 45 years. Notably, there are 7 trials targeting individuals under 18 years old and 245 trials focusing on those above the age of 65."

Answered by AI

Am I eligible to be a participant in this clinical trial?

"Individuals interested in participating must have a BMI indicating obesity and be between 20 and 45 years old. Approximately 100 eligible candidates will be enrolled."

Answered by AI

Are there any ongoing efforts to enroll patients in this clinical trial?

"Information from clinicaltrials.gov shows that this particular trial is no longer in the recruitment phase. The study was first listed on April 1, 2024, with the latest update made on February 14, 2024. Despite this trial being closed for enrollment, there are currently 280 other active studies seeking participants."

Answered by AI

Has the combination of Degarelix and transdermal estradiol been officially sanctioned by the FDA?

"Given that this investigation is in Phase 4, indicating regulatory approval, our team at Power deems the safety of Degarelix combined with transdermal estradiol to be a score of 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cardiometabolic Consequences of the Loss of Ovarian Function

2024. "Cardiometabolic Consequences of the Loss of Ovarian Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06264882.

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