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Estrogen + Estradiol Receptor Alpha Modulator

Estrogen + Estradiol Receptor Alpha Modulator Therapy for Sleep Apnea in Post-menopausal Women (Alpha MenoX Trial)

Phase 3
Recruiting
Research Sponsored by Laval University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BMI less/equal 35 kg.m-2
Regular exercise, dietary and sleep habits
Timeline
Screening 3 weeks
Treatment Varies
Follow Up changes between baseline and after 3 months drug treatment
Awards & highlights

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.

Eligible Conditions
  • Sleep Apnea
  • Postmenopausal
  • Stress Oxidative

Alpha MenoX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Your body mass index (BMI) is 35 or less.
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You have regular exercise, diet, and sleep habits.
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You don't have trouble sleeping and usually sleep more than 6 hours per night.
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Women who have stopped having their monthly periods and are between 45 and 65 years old.

Alpha MenoX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~changes between baseline and after 3 months drug treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and changes between baseline and after 3 months drug treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
oxidative stress
Secondary outcome measures
C-reactive protein
Orexin-A
arterial blood pressure
+6 more

Alpha MenoX Trial Design

2Treatment groups
Experimental Treatment
Group I: Post menopausal sleep apneaExperimental Treatment1 Intervention
Post menopausal women with severe sleep apnea
Group II: Post menopausal non sleep apneaExperimental Treatment1 Intervention
Post menopausal women without sleep apnea

Find a Location

Who is running the clinical trial?

Laval UniversityLead Sponsor
416 Previous Clinical Trials
172,240 Total Patients Enrolled
1 Trials studying Sleep Apnea
200 Patients Enrolled for Sleep Apnea
C RheaumeUNKNOWN
C MinvilleUNKNOWN

Media Library

Duavive (Estrogen + Estradiol Receptor Alpha Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT03981341 — Phase 3
Sleep Apnea Research Study Groups: Post menopausal sleep apnea, Post menopausal non sleep apnea
Sleep Apnea Clinical Trial 2023: Duavive Highlights & Side Effects. Trial Name: NCT03981341 — Phase 3
Duavive (Estrogen + Estradiol Receptor Alpha Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03981341 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
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~7 spots leftby Mar 2025