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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)
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 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.

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

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 more

Side effects data

From 2009 Phase 3 trial • 682 Patients • NCT00696878
18%
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
1,734 Previous Clinical Trials
2,148,828 Total Patients Enrolled
19 Trials studying Aging
4,295 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

Frequently Asked Questions

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

What research has been conducted involving GnRH antagonist thus far?

"At present, there are 72 live investigations concerning GnRH antagonist with 17 of these studies in the third phase. Even though a significant number of trials for this substance occur around Barcelona, Catalunya, a grand total of 2759 medical facilities are running tests on it."

Answered by AI

Are there any opportunities for recruitment in this experiment presently?

"Yes, the data available on clinicaltrials.gov indicates that this research endeavor is actively recruiting participants; it was first posted on November 22nd 2021 and most recently updated June 9th 2022. The study necessitates 55 enrollees at a single site to move forward with success."

Answered by AI

Has the FDA sanctioned GnRH antagonist for use in treatments?

"Given that this treatment has been authorised, our group at Power have assigned a rating of 3 for the safety profile of GnRH antagonists."

Answered by AI

Is my profile compatible with the requirements of this research trial?

"This clinical trial is looking to recruit 55 female participants aged between 18 and 55. It's important that they meet the following criteria: Inclusion Criteria - Healthy premenopausal and postmenopausal women will be sourced; their menstrual cycles must have a regular length, as confirmed with calendars (21-35 days), whilst postmenopausal candidates should have experienced natural menopause for at least 12 months but no more than 6 years ago. Additionally, we seek to ensure diversity in terms of race, ethnicity, socioeconomic background and educational attainment among our enrollees."

Answered by AI

How many participants are being accepted into this research project?

"Affirmative. The information on clinicaltrials.gov implies that recruitment for this experiment is still underway, with the initial posting date being November 22nd 2021 and most recent edit occurring June 9th 2022. There are 55 spots available at 1 location."

Answered by AI

Does this experiment welcome individuals aged eighty-five or above?

"This clinical trial is only open to adults between 18 and 55 years old. For those younger than 18 or older than 65, there are 12 trials available for the former population and 313 studies ready to accept patients from the latter group."

Answered by AI
~8 spots leftby Sep 2024