Experiences of a long-term randomized controlled prevention trial in a maiden environment: Estonian Postmenopausal Hormone Therapy trial
2008

Estonian Postmenopausal Hormone Therapy Trial

Sample size: 1823 publication Evidence: moderate

Author Information

Author(s): Hovi Sirpa-Liisa, Veerus Piret, Rahu Mati, Hemminki Elina

Primary Institution: Finnish Office for Health Technology Assessment (Finohta)

Hypothesis

Does postmenopausal hormone therapy (HT) increase health services utilization and affect health outcomes?

Conclusion

Flexibility was key to the success of the trial despite challenges from changes in the research environment.

Supporting Evidence

  • Recruitment occurred from 1999 to 2001 with 1823 women participating.
  • The trial was influenced by the Women's Health Initiative findings which led to changes in the trial protocol.
  • Flexibility in trial management was crucial to adapt to rapid societal changes in Estonia.

Takeaway

This study looked at how hormone therapy affects women's health and how changes in society can impact medical trials.

Methodology

A four-arm randomized controlled trial with both blind and non-blind sub-studies conducted in Estonia.

Potential Biases

Potential bias due to reliance on public funding and the influence of external studies on trial decisions.

Limitations

Low adherence and relatively short exposure time reduced the power of the study.

Participant Demographics

Women aged 50 to 79, recruited from three study centers in Estonia.

Digital Object Identifier (DOI)

10.1186/1471-2288-8-51

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