title: Improving the objective quality of large-scale clinical trials for women with heavy menstrual bleeding: experience from 2 multi-center, randomized trials.
abstract: This study demonstrates a robust and thorough trial design leading to accurate and objective data collection. We recommend that future studies investigating heavy menstrual bleeding (HMB) should follow, and improve upon, this rigorous approach to menstrual trial data collection, not only to validate clinical results but also to improve the techniques used to acquire these results. We propose that the state-of-the-art methodology described here be used as the basis for new guidelines for the implementation of clinical trials in the area of HMB.
authors: University of Sydney and Sydney Centre for Reproductive Health Research, Family Planning NSW, Sydney, New South Wales, Australia. ian.fraser@sydney.edu.au
authors: Ian S
authors: IS
authors: Fraser
authors: Susan
authors: S
authors: Zeun
authors: Susanne
authors: S
authors: Parke
authors: Baerbel
authors: B
authors: Wilke
authors: Wolfgang
authors: W
authors: Junge
authors: Marco
authors: M
authors: Serrani
mesh_terms: D003276:Contraceptives, Oral / Q000008:administration & dosage*; D004311:Double-Blind Method; D004338:Drug Combinations; D004958:Estradiol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D038622:Internationality; D008595:Menorrhagia / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D009277:Nandrolone / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D003276:Contraceptives, Oral; D004338:Drug Combinations; C454300:estradiol valerate-dienogest; D004958:Estradiol; D009277:Nandrolone
keywords: clinical trial methodology; heavy menstrual bleeding; menstrual blood collection; menstrual blood loss; menstrual blood quantification