CompletedNot Applicable

Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function

United States19 participantsStarted 2018-02-07

Plain-language summary

Complaints about memory and thinking are common in women as they go through menopause. The female hormone estrogen is important for both the health of both the brain and the blood vessels. In Alzheimer's disease there is damage to the blood vessels in the brain. This study will look at how the loss of the female hormone estrogen affects brain function and the health of blood vessels.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Stages of Reproductive Aging Workshop (STRAW+10) peak or late reproductive stage (-4, -3b or -3a) * Healthy based on medical history, physical examination and standard blood chemistries * Normotensive (resting blood pressure \<140/90 mmHg) * Normoglycemia (fasting glucose \<110mg/dl and hemoglobin A1c\<6.5%) * Non-smoker (for at least 12 months) Exclusion Criteria: * Serum Follical Stimulating Hormone (FSH) \>25mIU/mL measured during the first 5 days of the menstrual cycle * Use of hormonal therapy within the past 3 months * Use of antihypertensive or lipid-lowering medications * Pregnant or lactating, or planning to become pregnant during the study period * Known hypersensitivity to any of the study medications * Abnormal vaginal bleeding * History of venous thromboembolism or hormone-sensitive cancer * History of neurologic disease or major psychiatric illness * History of diagnosed learning disability or less than high-school education * Contraindication to Magnetic Resonance Imaging (MRI) scanning * Depression (Center for Epidemiological Studies - Depression (CESD) score \>16) * Significant cognitive impairment (Mini Mental State Examination (MMSE) score \<27) * Severe osteopenia or osteoporosis (proximal femur or lumbar spine T-score \< -2.0) * Body Mass Index (BMI) \>40kg/m2

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in Prefrontal cortex brain activation

Timeframe: Baseline, 3 months

Trial details

NCT IDNCT03112226

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-06

View on ClinicalTrials.gov More Cognitive Impairment trials