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New treatment option for Menopause
Official title Cardiometabolic Consequences of the Loss of Ovarian Function
ClinicalTrials.gov ID: NCT06264882
What this study is testing
What is Degarelix?
Degarelix is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for menopause.
Also referred to as GnRH antagonist, Ovarian suppression.
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 menopause transition is associated with a decrease in artery health and an increased risk for weight gain in storing fat in the stomach area which may increase the risk for heart disease. The purpose of this research is to study how the decrease in estrogen at menopause changes artery health and fat gain, and risk of disease in women as they age.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- Age criteria of 20-45 years: the investigators are determining the effects of ovarian suppression on adiposity and vascular in premenopausal women;
- Premenopausal defined as normal menstrual cycle function defined as no more than 1 missed cycle in the previous year: irregular menstrual or missed...
- Not pregnant or planning to become pregnant;
- Not lactating in the last 3 months;
- Serum FSH \<10 IU/L measured during days 1-10 of the menstrual cycle: to ensure the woman is premenopausal and not perimenopausal;
You likely can't join if
- Diabetic or fasted glucose \>126 mg/dL;
- Body mass index (BMI) \>35 kg/m2;
- Weight change \>5 kg in the last 3 months;
- Use of glucocorticoids (inhaled, oral, topical) or drugs that affect glucocorticoid metabolism (e.g., ketoconazole) in the last 3 months;
- Excess alcohol consumption, defined as \>14 drinks per week by self-report;
- Known hypersensitivity to study medications;
See the full eligibility criteria
- Age criteria of 20-45 years: the investigators are determining the effects of ovarian suppression on adiposity and vascular in premenopausal women;
- Premenopausal defined as normal menstrual cycle function defined as no more than 1 missed cycle in the previous year: irregular menstrual or missed menstrual cycles could indicate that women are anovulatory and/or...
- Not pregnant or planning to become pregnant;
- Not lactating in the last 3 months;
- Serum FSH \<10 IU/L measured during days 1-10 of the menstrual cycle: to ensure the woman is premenopausal and not perimenopausal;
- Not on hormonal contraception in the last 3 months;
- Sedentary or recreationally active (\<2 days/wk vigorous exercise);
- No use of medications that might influence vascular function (i.e., antihypertensives, lipid lowering medications, blood thinners);
- No use of antioxidant supplements or chronic NSAIDs or be willing to go off them for 4 weeks prior to enrollment in the study;
- Diabetic or fasted glucose \>126 mg/dL;
- Body mass index (BMI) \>35 kg/m2;
- Weight change \>5 kg in the last 3 months;
- Use of glucocorticoids (inhaled, oral, topical) or drugs that affect glucocorticoid metabolism (e.g., ketoconazole) in the last 3 months;
- Excess alcohol consumption, defined as \>14 drinks per week by self-report;
- Known hypersensitivity to study medications;
- Depressive symptoms, defined as a CES-D score \>16;
- Resting blood pressure \>150/90 mmHg;
- Preexisting or active cardiac, renal, or hepatic disease: past or current history of these diseases or conditions;
- Active or chronic infection: inflammation associated with active or chronic infections impair vascular function;
- Thyroid dysfunction, defined as an ultrasensitive TSH \ 5.0 mU/L; volunteers with abnormal TSH values will be reconsidered for participation in the study after follow-up evaluation by the PCP with initiation or...
- Smoking or Tobacco use within the previous 12 months;
- Severe low bone mass or osteoporosis, defined as a hip or lumbar spine T-score \<-2.0: safety reasons, women who are assigned by chance to the ovarian suppression plus placebo group could see a decrease in bone mineral...
- History of venous thromboembolic event (VTE): safety reasons, estradiol therapy can increase the risk of VTE;
- History of breast cancer or other estrogen-dependent neoplasm: estradiol therapy is contraindicated;
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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, 20 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.