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Estrogen + Estradiol Receptor Alpha Modulator Therapy for Sleep Apnea in Post-menopausal Women (Alpha MenoX Trial)
Alpha MenoX Trial Summary
This trial will compare levels of oxidative stress in postmenopausal women with and without sleep apnea, and will test whether treatment with an estrogen receptor agonist can reduce oxidative stress in women with sleep apnea.
- Sleep Apnea
- Postmenopausal
- Stress Oxidative
Alpha MenoX Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAlpha MenoX Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Alpha MenoX Trial Design
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Who is running the clinical trial?
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- You don't have trouble sleeping and usually sleep more than 6 hours per night.Taking hormonal medication.You have severe daytime sleepiness that needs to be treated right away.Your body mass index (BMI) is 35 or less.You have a specific number of pauses in breathing during sleep, as measured by a sleep test.90% of breathing pauses during sleep are caused by blockages in the airway.You have regular exercise, diet, and sleep habits.You have trouble breathing at night, with low oxygen levels and high carbon dioxide levels in your blood.You are taking any medication that can slow down your breathing.Women who have stopped having their monthly periods and are between 45 and 65 years old.
- Group 1: Post menopausal sleep apnea
- Group 2: Post menopausal non sleep apnea
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Who is able to sign-up for this clinical trial?
"Patients who want to be enrolled in this clinical trial must exhibit stress oxidative symptoms and be between 45-65 years old. At maximum, 36 patients will be accepted into the study."
Are we still receiving applications for this research project?
"That is correct, the information available on clinicaltrials.gov points to this trial being actively recruiting patients. The listing for this study was first posted on November 1st, 2019 with a recent update having been made on April 6th, 2022. Currently, the study is looking for 36 individuals from 1 location."
What is the total sample size for this research project?
"The latest information available on clinicaltrials.gov suggests that this trial is still in the process of recruiting participants. The listing for the study was created on November 1st, 2019 and updated as recently as April 6th, 2022. Presently, they are looking to enroll 36 patients from a single location."
What are some other examples of this type of trial?
"First studied in 2012, Duavive (0.45 estrogens mg and 20 mg bazedoxifene) has undergone 16 clinical trials in the last 8 years. These international studies are being conducted across 24 cities in 5 different countries."
Could you please summarize the research that has been done on Duavive?
"Currently, there are 16 live studies investigating Duavive (0.45 estrogens mg and 20 mg bazedoxifene), with 1 trials in Phase 3. While several of the clinical trials for Duavive are based in League City, Texas, there are 32 locations operating clinical trials for Duavive across the United States."
Does this research include geriatric patients in its trials?
"This particular clinical trial only enrolls patients that are between 45 and 65 years old. If you do not fit this age criteria, don't worry! There are 47 other trials for patients under 18 and 264 for those over 65."
Has the FDA cleared Duavive for patient use?
"Given that this is a Phase 3 trial with supporting efficacy data as well as multiple rounds of safety data, Power has given Duavive (0.45 estrogens mg and 20 mg bazedoxifene) a score of 3 for safety."
What are some common reasons why patients take Duavive?
"Duavive, a medication containing 0.45mg of estrogen and 20mg of bazedoxifene, is often used to treat premature menopause. It can also offer relief for other conditions such as female castration, vasomotor system dysregulation, and standard menopause symptoms."
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