Your session is about to expire
← Back to Search
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 12 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline at 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Aortic stiffness and pulsatile hemodynamics
Secondary outcome measures
Common carotid artery stiffness and pulsatile hemodynamics
Macrovascular cerebral blood flow
Macrovascular cerebrovascular reserve
+1 moreSide effects data
From 2009 Phase 3 trial • 682 Patients • NCT0069687818%
Procedural pain
9%
Headache
7%
Abortion spontaneous
7%
Pelvic pain
5%
Pelvic discomfort
1%
Ectopic pregnancy
1%
Ovarian hyperstimulation syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Corifollitropin Alfa 150 µg
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
1,752 Previous Clinical Trials
2,165,544 Total Patients Enrolled
20 Trials studying Aging
4,695 Patients Enrolled for Aging
Lyndsey DuBose, PhDPrincipal InvestigatorUniversity of Colorado Denver Anschutz Medical Campus
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bone density test shows I have osteopenia or osteoporosis.I have not used hormonal therapies or contraceptives in the last 3 months and do not plan to start during the study.I do not have any major illnesses like diabetes, cancer (other than melanoma), liver or heart disease that could affect the study.I am not allergic to Degarelix or its components.I haven't had a serious illness, fever, or positive COVID test in the last 6 months.I am a premenopausal woman with regular menstrual cycles between 21-35 days.I am a healthy woman, either before or after menopause.My fasting blood sugar level is above 126 mg/dl.I am a premenopausal woman with regular menstrual cycles between 21-35 days.I am a postmenopausal woman who naturally stopped having periods between 1 and 6 years ago.My recent tests show abnormal thyroid, liver, or kidney function.I don't take vitamins/supplements or anti-inflammatory meds, or I can stop them 1 month before the vascular visit.I am a healthy woman and either premenopausal or postmenopausal.I am a woman who naturally entered menopause between 1 and 6 years ago.You have symptoms of depression, as measured by a questionnaire, with a score of 16 or higher. However, if a doctor determines you are still eligible for the study, despite the score, it will be noted in your study chart.I have experienced vaginal bleeding without a known cause.I am taking medication that could affect my heart or brain blood flow.
Research Study Groups:
This trial has the following groups:- Group 1: Premenopausal Group: GnRH antagonist
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger