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Hormone Therapy

GnRH Antagonist for Menopause

Phase 4
Waitlist Available
Led By Lyndsey DuBose, 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
Osteopenia or osteoporosis (i.e., proximal femur or lumbar spine DXA T scores <-1.0)
Contraindications to Degarelix including hypersensitivity to degarelix acetate, extrinsic peptide hormones, mannitol, GnRH, benzyl alcohol (the vehicle for injection of degarelix acetate)
Must not have
Plasma glucose >126 mg/dl under fasting conditions
Abnormal thyroid, liver, or kidney function testing during the screening examination or bloodwork
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 12 weeks
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will evaluate how the loss of female sex hormones affects blood vessels around the heart and in the brain in women during the menopause transition.

Who is the study for?
This trial is for healthy premenopausal and postmenopausal women experiencing the menopause transition, with regular menstrual cycles or natural menopause. Participants should not have high blood pressure, be on certain medications, pregnant, or have a BMI over 39. They must not smoke or live with a smoker.
What is being tested?
The study investigates how the loss of female sex hormones like estrogen during menopause affects heart and brain blood vessels. It aims to understand if these changes increase risks for cardiovascular disease and Alzheimer's. A GnRH antagonist will be used to study these effects.
What are the potential side effects?
Potential side effects are not explicitly listed in the provided information but may include reactions related to hormone fluctuations such as hot flashes, mood swings, headaches, or injection site reactions due to the GnRH antagonist.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My bone density test shows I have osteopenia or osteoporosis.
Select...
I am not allergic to Degarelix or its components.
Select...
I am a premenopausal woman with regular menstrual cycles between 21-35 days.
Select...
I have experienced vaginal bleeding without a known cause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My fasting blood sugar level is above 126 mg/dl.
Select...
My recent tests show abnormal thyroid, liver, or kidney function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Aortic stiffness and pulsatile hemodynamics
Secondary study objectives
Common carotid artery stiffness and pulsatile hemodynamics
Macrovascular cerebral blood flow
Macrovascular cerebrovascular reserve
+1 more

Side effects data

From 2009 Phase 3 trial • 682 Patients • NCT00696878
18%
Procedural pain
9%
Headache
7%
Pelvic pain
7%
Abortion spontaneous
5%
Pelvic discomfort
1%
Ovarian hyperstimulation syndrome
1%
Ectopic pregnancy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Corifollitropin Alfa 150 µg

Awards & Highlights

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.
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: Premenopausal Group: GnRH antagonistExperimental Treatment1 Intervention
Gonadotropin releasing hormone (GnRH) antagonist is degarelix acetate, 80 mg, delivered once as a subcutaneous injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GnRH antagonist
2017
Completed Phase 4
~3570

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,809 Previous Clinical Trials
2,822,203 Total Patients Enrolled
20 Trials studying Aging
4,655 Patients Enrolled for Aging
Lyndsey DuBose, PhDPrincipal InvestigatorUniversity of Colorado Denver Anschutz Medical Campus

Media Library

GnRH antagonist (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05057546 — Phase 4
Aging Research Study Groups: Premenopausal Group: GnRH antagonist
Aging Clinical Trial 2023: GnRH antagonist Highlights & Side Effects. Trial Name: NCT05057546 — Phase 4
GnRH antagonist (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05057546 — Phase 4
~14 spots leftby Dec 2025
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