Menopause study: GnRH antagonist vs Estrogen Product
Official title Bioenergetic Effects of Aging and Menopause (BEAM)
ClinicalTrials.gov ID: NCT04043520
What this study is testing
What is GnRH antagonist?
This is an investigational medicine being studied to see if it helps with belly fat changes during menopause. It is designed to block the body's natural GnRH signals to lower levels of FSH and other hormones.
Also referred to as Degarelix Acetate.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out if cortisol, a stress hormone, causes women to store more fat in their bellies during menopause.
- Who it's for
- The study is looking for women who are going through menopause and have gained weight or have belly fat.
- What's involved
- Participants will likely undergo tests to measure hormone levels and body composition, though specific procedures are not detailed in the source.
- Time commitment
- The source text does not specify the duration of the study or the number of visits required.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 65, women only. Healthy volunteers may be eligible.
You may be able to join if
- Volunteers will be healthy peri/postmenopausal women who are willing and able to undergo the proposed hormone manipulation and study procedures.
You likely can't join if
- abnormal vaginal bleeding
- on hormonal contraceptive or menopausal therapy or intention to start during the period of study
- positive pregnancy test or intention to become pregnant during the period of study
- lactation
- known hypersensitivity to degarelix acetate, estradiol, or medroxyprogesterone acetate
- Center for Epidemiological Studies Depression Scale (CES-D) score \<,16 (unless clinician follow-up and clinical judgement determine they are...
See the full eligibility criteria
- Volunteers will be healthy peri/postmenopausal women who are willing and able to undergo the proposed hormone manipulation and study procedures.
- abnormal vaginal bleeding
- on hormonal contraceptive or menopausal therapy or intention to start during the period of study
- positive pregnancy test or intention to become pregnant during the period of study
- lactation
- known hypersensitivity to degarelix acetate, estradiol, or medroxyprogesterone acetate
- Center for Epidemiological Studies Depression Scale (CES-D) score \<,16 (unless clinician follow-up and clinical judgement determine they are eligible (will be noted in study chart)
- current tobacco and/or vape use more than 2 times/week
- current marijuana or tetrahydrocannabinol (THC) use in any form more than 3 times/week
- regular self-reported alcohol consumption \>14 drinks/week
- BMI \>39 kg/m2
- use of glucocorticoids or drugs that affect glucocorticoid metabolism (e.g., ketoconazole)
- severe osteopenia or osteoporosis, defined as femoral neck or lumbar spine t-score \<-2.0
- thyroid dysfunction, defined as an ultrasensitive TSH \ 5.0 mU/L; volunteers with abnormal thyroid stimulating hormone (TSH) values will be re-considered for participation in the study after follow-up evaluation by the...
- liver dysfunction, defined as liver function tests (AST, ALT) \>1.5 times the upper limit of normal
- uncontrolled hypertension defined as resting systolic BP \>150 mmHg or diastolic BP\>90 mmHg; participants who do not meet these criteria at first screening will be re-evaluated, including after follow-up evaluation by...
- self-reported history of breast cancer or other estrogen-dependent neoplasms
- self-reported history of venous thromboembolism, pulmonary embolism, or other thromboembolic disorder
- self-reported history of cardiovascular disease
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.