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NCT06578169 | NOT YET RECRUITING | Asthma


Initiation of Exogenous Female Sex Hormones and Airway Responsiveness to Methacholine - A Prospective Cohort Study
Sponsor:

Copenhagen University Hospital, Hvidovre

Information provided by (Responsible Party):

Erik Soren Halvard Hansen

Brief Summary:

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.

Condition or disease

Asthma

Intervention/treatment

Hormonal Therapy Agent

Study Type : OBSERVATIONAL
Estimated Enrollment : 300 participants
Official Title : Initiation of Exogenous Female Sex Hormones and Airway Responsiveness to Methacholine - A Prospective Cohort Study
Actual Study Start Date : 2024-09-01
Estimated Primary Completion Date : 2027-09-01
Estimated Study Completion Date : 2027-09-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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

Initiation of Exogenous Female Sex Hormones and Airway Responsiveness to Methacholine - A Prospective Cohort Study

Location Details

NCT06578169


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