NCT02039102

Brief Summary

Studies examining the sex differences in the epidemiology and morbidity patterns of asthma show that the rates of disease severity, healthcare utilisation, and poor quality of life are considerably higher in women than in men, and this has been attributed to endogenous and exogenous sex hormonal factors. Studies examining the impact of use of hormonal contraceptives on the risk of asthma and asthma-related conditions are few, yet findings are conflicting. In the present study, the investigators utilize data from the Scottish Health Survey, a national representative sample, to investigate the associations between current use of hormonal contraceptives and the prevalence of self-reported doctor-diagnosed current asthma and wheezing symptoms in Scottish women. The investigators hypothesize that while current use of any hormonal contraceptives and combined oral pills are associated with higher prevalence of asthma and asthma outcomes, current use of progesterone-only contraceptives is not associated with asthma. A secondary aim of the current study is to examine whether there is evidence of any biological interaction between use of hormonal contraceptives and BMI in relation to the risk of asthma and asthma outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,257

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

4.8 years

First QC Date

January 15, 2014

Last Update Submit

June 18, 2021

Conditions

Keywords

hormonal contraceptivescombined pillsprogesterone-only contraceptivesbody mass indexasthmaScotlandwomen

Outcome Measures

Primary Outcomes (1)

  • Self-reported doctor-diagnosed current asthma

    During the past 12 months

Secondary Outcomes (2)

  • Self-reported wheezing symptom

    During the past 12 months

  • Self-reported current treatment for asthma/wheeze

    During the past 12 months

Study Arms (2)

Non-users of hormonal contraceptives

Users of hormonal contraceptives

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Non-pregnant women aged 16-45 years

You may qualify if:

  • Non-pregnant
  • Woman
  • years old

You may not qualify if:

  • Pregnant
  • Man
  • Younger than 16 years or older than 45 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ediburgh

Edinburgh, United Kingdom

Location

Related Publications (3)

  • Macsali F, Real FG, Omenaas ER, Bjorge L, Janson C, Franklin K, Svanes C. Oral contraception, body mass index, and asthma: a cross-sectional Nordic-Baltic population survey. J Allergy Clin Immunol. 2009 Feb;123(2):391-7. doi: 10.1016/j.jaci.2008.10.041. Epub 2009 Jan 3.

    PMID: 19121863BACKGROUND
  • Lange P, Parner J, Prescott E, Ulrik CS, Vestbo J. Exogenous female sex steroid hormones and risk of asthma and asthma-like symptoms: a cross sectional study of the general population. Thorax. 2001 Aug;56(8):613-6. doi: 10.1136/thorax.56.8.613.

    PMID: 11462063BACKGROUND
  • Salam MT, Wenten M, Gilliland FD. Endogenous and exogenous sex steroid hormones and asthma and wheeze in young women. J Allergy Clin Immunol. 2006 May;117(5):1001-7. doi: 10.1016/j.jaci.2006.02.004.

    PMID: 16675325BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2014

First Posted

January 17, 2014

Study Start

December 1, 2013

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

June 21, 2021

Record last verified: 2021-06

Locations