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New treatment option for Estrogen
Official title Disentangling the Effects of Daily Stress, Sleep, and Sex Hormones on Accelerated Vascular Aging in Midlife Women
ClinicalTrials.gov ID: NCT06745466
What this study is testing
What is ganirelix acetate?
ganirelix acetate is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for estrogen.
Also referred to as Antagon.
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 purpose of this study is to identify the impact of estradiol (E2) on the associations between (a) responsivity to daily stress or (b) sleep variability with vascular function in midlife premenopausal women.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 55, women only. Healthy volunteers may be eligible.
You may be able to join if
- Female
- Age 40-55
- Premenopausal
You likely can't join if
- Pregnancy (including a positive urine pregnancy test), planning to become pregnant, or breast-feeding
- Peri- or post-menopausal
- Unstable or diagnosed chronic clinical disease, including cardiovascular, metabolic, renal, hepatic, autonomic, autoimmune, or dermatological disease
- Current or lifetime major psychiatric illness (e.g., major depressive disorder, bipolar disorder, schizophrenia, eating disorders)
- History of hysterectomy (complete or partial), polycystic ovary syndrome, endometrial hyperplasia, irregular menstrual cycles, or endometrial ablation
- Suspected potential presence of obstructive sleep apnea (STOP-Bang score \>3) or insomnia (Insomnia Severity Index score \>15)
See the full eligibility criteria
- Female
- Age 40-55
- Premenopausal
- Pregnancy (including a positive urine pregnancy test), planning to become pregnant, or breast-feeding
- Peri- or post-menopausal
- Unstable or diagnosed chronic clinical disease, including cardiovascular, metabolic, renal, hepatic, autonomic, autoimmune, or dermatological disease
- Current or lifetime major psychiatric illness (e.g., major depressive disorder, bipolar disorder, schizophrenia, eating disorders)
- History of hysterectomy (complete or partial), polycystic ovary syndrome, endometrial hyperplasia, irregular menstrual cycles, or endometrial ablation
- Suspected potential presence of obstructive sleep apnea (STOP-Bang score \>3) or insomnia (Insomnia Severity Index score \>15)
- Current or recent (within 8 wks) use of medications that could conceivably alter cardiovascular function or sleep health
- Changes or alterations in medication status (starting a new, additional, or different medication or changing the dose of a current medication)
- Body mass index \>35 kg/m2
- Tobacco or nicotine use, including vaping and electronic cigarettes
- Working night-time or rotating shift work within the previous 3 months
- Trans-meridian travel during study enrollment (inclusive of the entire duration of enrollment and the period between testing cycles)
- Known allergies to pharmacological agents/drugs
- Current use of long-acting reversible contraception (LARC; e.g., IUDs, birth control implants)
- Known latex allergy
The study team makes the final eligibility decision.
Where it's taking place
- Newark, Delaware, 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, 40 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newark, Delaware, 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.