Methodology and challenges to recruitment to a randomized, double-blind, placebo-controlled trial of oral DHEA in postmenopausal women.

J Womens Health (Larchmt)

NH&MRC Centre of Clinical Research Excellence in the Women's Health Program, Department of Medicine, Central and Eastern Clinical School, Monash University, Alfred Hospital, Prahran, Victoria, Australia.

Published: December 2008

AI Article Synopsis

  • The study aimed to investigate challenges in recruiting healthy menopausal women for a DHEA therapy trial targeting low sexual desire.
  • Approximately 918 women expressed interest, but only 10% were randomized due to high rates of ineligibility and withdrawal of interest.
  • Key barriers included concerns about hormonal treatments and the busy lifestyles of midlife women, highlighting the need for tailored recruitment strategies in future studies.

Article Abstract

Objective: To report on the issues encountered in the recruitment of healthy naturally menopausal women in the community to a randomized placebo-controlled trial of dehydroepiandrosterone (DHEA) therapy for treatment of loss of sexual desire.

Methods: Recruitment of women was achieved by advertising and media publicity. We have reported on the method by which women initially contacted us and the reasons for nonparticipation.

Results: Nine hundred and eighteen women contacted us about participating in the study; 706 of these were telephoned screened, and 93 of these (10%) women were randomized to therapy. The main determinants for nonparticipation included ineligibility on phone screening (58%), withdrawal of interest either before or after screening (55%), and preexisting pathology after attending for screening (8%).

Conclusions: Despite ongoing interest by women to participate in research for therapies to treat low libido, concerns about the use of any hormonal treatment and the time poverty experienced by many women at midlife present new barriers to recruitment and need to be considered in assessing the feasibility of studies in this field.

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Source
http://dx.doi.org/10.1089/jwh.2007.0732DOI Listing

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