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

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 exp...