Methodology and Challenges to Recruitment to a Randomized, Double-Blind, Placebo-Controlled Trial of Oral DHEA in Postmenopausal Women
November 2008
in “
Journal of Womens Health
”
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Studysummary This study found that recruiting healthy naturally menopausal women for a DHEA therapy trial was challenged by concerns about hormonal treatments and time constraints, impacting study feasibility. Our plain-language summary of this paper — not a Tressless recommendation.
In 2008, researchers encountered significant recruitment challenges for a study evaluating the effect of DHEA on sexual desire in postmenopausal women. Despite 918 women expressing interest, only 93 (10%) were ultimately randomized into the trial. The main barriers to participation included ineligibility (58%), loss of interest (55%), and preexisting conditions (8%). The study's target was 89 women per treatment group to ensure statistical power, but this goal was not met. Additionally, 45% of the 296 eligible women agreed to screening, but only 93 completed the process and were randomized. Concerns about hormonal treatments, the time commitment, and the prohibition of financial incentives in Australia were noted as significant obstacles to recruitment. The researchers emphasized the need to address these issues in future studies.
