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NCT06578169Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 29 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
13 Aug 2024
Start date
1 Sept 2024
Primary completion date
1 Sept 2027
Lead sponsor
Copenhagen University Hospital, Hvidovre
Diseases
Asthma
NCT number
NCT06578169

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 1 Sept 2024 to the primary completion date, 1 Sept 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current hormonal medication

Other illness

  • Gynecological, endocrinological or other disease affecting the ovarian cycle

Other

  • FEV1 \< 60% of expected or \< 1.5L
  • Pregnancy

Who the study is looking for

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

Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.