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GnRH Antagonist for Menopause
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2009 Phase 3 trial • 682 Patients • NCT00696878Trial Design
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- 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.
- Group 1: Premenopausal Group: GnRH antagonist
- 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.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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