Recruiting
Phase 3

Estrogen & Estradiol

Sponsor:

Laval University

Code:

NCT03981341

Conditions

Sleep Apnea

Post Menopausal

Oxidative Stress

Eligibility Criteria

Sex: Female

Age: 45 - 65

Healthy Volunteers: Not accepted

Interventions

Duavive (0.45 estrogens mg and 20 mg bazedoxifene)

Study Details

Brief summary:

One of the most likely mechanisms explaining the sleep apnea (SA)-induced increase in metabolic syndrome is the oxidative stress (OS) induced by intermittent hypoxia (IH). There are clear-cut signs of OS in postmenopausal women that may be further enhanced by SA. In rats exposed to IH, an estradiol receptor alpha agonist decreases the level of OS markers. The aims of this study are to compare OS in apneic and non-apneic postmenopausal women and to demonstrate that OS will improve after 3 months of treatment with ER alpha agonists (Duavive) in apneic post-menopausal women.

Conditions

Sleep Apnea

Post Menopausal

Oxidative Stress

Study ID

NCT03981341

Start date

Nov 1, 2019

Status verified date

Apr, 2022

Completion date

Dec 1, 2023

Anticipated

Primary completion date

Dec 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • post-menopausal women
  • aged 45 to 65 years
  • BMI less/equal 35 kg.m-2,
  • apnoea + hypopnea index (AHI) < 15/h (non SA group) or ≥ 30/h (SA group) on a polysomnographic recording,
  • 90% of AHI associated with obstructive events,
  • regular exercise, dietary and sleep habits
  • free of sleep debt (insomnia, reported habitual sleep time > 6 h/night),
  • stable medical condition.

Exclusion Criteria:

  • clinically significant diurnal somnolence requiring immediate treatment in SA patients,
  • nocturnal hypoventilation (% sleep time below 90% SaO2 > 10 %, PaCO2 > 45 mmHg),
  • use of hormonal therapy,
  • use of any medication with a respiratory depressant effect (narcotics),
  • contraindication to the dug used in the protocol

Study Design

Enrollment

36 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Post menopausal sleep apnea

Post menopausal women with severe sleep apnea

experimental: Post menopausal non sleep apnea

Post menopausal women without sleep apnea

Interventions

Duavive (0.45 estrogens mg and 20 mg bazedoxifene)

Drug given for 3 months in each participant

Primary outcome measure

  • oxidative stress [ Time Frame: Changes between baseline and after 3 months drug treatment ]

Central Contacts and Locations

Central contacts

Frederic Series

418 656 8711frederic.series@med.ulaval.ca

Locations

IUCPQ

Recruiting

Quebec, Canada, G1V 4G5

Contacts

Frederic Series, MD

418 656 8711frederic.seriesd@med.ulaval.ca

Principal Investigator:

Frederic Series, MD

More Information

Sponsor

Laval University

Last update posted

Apr 8, 2022

Last verified

Apr, 2022

Keywords

  • sleep apnea
  • post menopausal
  • oxidative stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2022-04-08.