Menopause study: Cyclic Estradiol vs Continuous Estradiol
Official title Cyclic vs. Constant Estradiol: Regimens' Effects on Brain Health
ClinicalTrials.gov ID: NCT07831499
What this study is testing
What is Cyclic Estradiol?
an investigational transdermal estradiol patch being studied for menopause is designed to deliver estradiol, a form of estrogen, through the skin to replace declining hormone levels and influence brain and body processes
Also referred to as Estradiol Patch, Transdermal Estradiol.
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 how an estradiol patch influences brain function, overall health, and wellbeing.
- Who it's for
- Postmenopausal women who are otherwise healthy.
- What's involved
- Participants will wear an estradiol patch using either a cyclic or a constant dosing schedule and will undergo study visits and brain-related tests.
- 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 38 to 60, women only. Healthy volunteers may be eligible.
You may be able to join if
- Ages 38 to 60.
- Ability to give written informed consent.
- Fluent in written and verbal English, though may use Spanish to speak with study staff if preferred.
- Participants must be up to date on age-appropriate cancer screening.
- Have estradiol level below 40 pg/ml and follicle stimulating hormone (FSH) level above 25 at Van Visit Day 1.
You likely can't join if
- Current psychiatric diagnosis as assessed by the Mini International Neuropsychiatric Interview (MINI, Sheehan et al., 1998).
- Active psychiatric illness within the previous 12 months or lifetime diagnosis of a psychotic disorder.
- Current use of antipsychotic medications or mood stabilizers. Participants may have sporadic use of benzodiazepines during the course of the study as...
- Current or history of substance use disorder within previous 12 months.
- Chronic use of steroid medication and other medications that could impact immune function and alter glucocorticoid levels.
- Inability to forgo use of non-steroidal anti-inflammatory medications for 4 days prior to the Baseline Visit, Van Visits, and Follow Up Visit.
See the full eligibility criteria
- Ages 38 to 60.
- Ability to give written informed consent.
- Fluent in written and verbal English, though may use Spanish to speak with study staff if preferred.
- Participants must be up to date on age-appropriate cancer screening. Specifically, participants must have had a pap smear within the previous 3 years and a mammogram within the previous 2 years (American College of...
- Have estradiol level below 40 pg/ml and follicle stimulating hormone (FSH) level above 25 at Van Visit Day 1.
- Report final menstrual period (FMP) occurred between 12 months and 48 months at the time of screening.
- Right-handed.
- Participants are required to have at least some college education. Setting a minimum education level reduces variability due to educational disparities and supports the validity and interpretability of cognitive...
- Current psychiatric diagnosis as assessed by the Mini International Neuropsychiatric Interview (MINI, Sheehan et al., 1998).
- Active psychiatric illness within the previous 12 months or lifetime diagnosis of a psychotic disorder.
- Current use of antipsychotic medications or mood stabilizers. Participants may have sporadic use of benzodiazepines during the course of the study as long as they can forgo use at least 4 days prior to study procedures.
- Current or history of substance use disorder within previous 12 months. However, individuals with mild disorders, disorders solely limited to cannabis or alcohol, and/or those who have achieved close to one year of...
- Chronic use of steroid medication and other medications that could impact immune function and alter glucocorticoid levels.
- Inability to forgo use of non-steroidal anti-inflammatory medications for 4 days prior to the Baseline Visit, Van Visits, and Follow Up Visit.
- Any current or recent medical, psychiatric or social condition which, in the investigator's opinion, is likely to interfere with the conduct of the study, confound the interpretation of study results, or endanger the...
- Use of systemic hormone therapy (including but not limited to estradiol, progesterone, testosterone, combined hormonal contraceptives, and other systemic hormonal preparations) within 3 months prior to study enrollment.
- History of suicidal behavior within the past 2 years
- Undiagnosed abnormal genital bleeding.
- Known, suspected, or history of breast cancer.
- Active deep vein thrombosis, pulmonary embolism, or history of these conditions.
- History of cardiovascular disease
- Known liver dysfunction or disease.
- Needle phobia or history of vasovagal response to phlebotomy.
- History of clinically relevant claustrophobia or inability to tolerate a scanning environment in the past.
- Metal in body unsafe for magnetic resonance imaging (MRI) or other conditions that would make MRI unsafe for participants (i.e., aneurysm clip, cardiac pacemaker, etc.).
- Current treatment with Central nervous system (CNS) depressants (e.g., opioids, benzodiazepines).
- Treatment with corticosteroids within the past 30 days.
- Known allergy to progesterone or peanut allergy.
- Any history of chemotherapy as negative effects on cognitive performance have been reported for years post cessation of treatment (Guida et al., 2021; Koppelmans et al., 2012).
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, 38 years to 60 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.