Initiation of Exogenous Female Sex Hormones and Airway Responsiveness to Methacholine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2027-09-01

Brief Summary

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The project aims to investigate the effect of female sex hormone treatment (both contraceptive treatment and hormone therapy during menopause) on bronchial hyperreactivity in adult women. The study is a prospective cohort study involving 300 women, examining airway responsiveness before and after the initiation of hormone treatment, whether as hormone therapy in menopause or contraceptive treatment. Participants will be recruited from general practitioners in the Capital Region of Denmark. Lung function, bronchial hyperreactivity, airway inflammation, and body composition will be assessed before and after hormone treatment. Blood samples will also be collected and stored for later analysis of inflammation markers. The study will include women aged 18 to 75 who are about to begin hormone treatment.

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Detailed Description

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Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Hormonal Therapy Agent

Women initiating either Hormonal Contraceptives or Hormone replacement therapy in menopause

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women aged 18 to 75 years
* Planning to initiate HRT/HC within next 30 days

Exclusion Criteria

* Gynecological, endocrinological or other disease affecting the ovarian cycle
* FEV1 \< 60% of expected or \< 1.5L
* Current hormonal medication
* Pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No