Dysfunctional Uterine Bleeding Study
Research status
Completed
Overview of Study
Dysfunctional uterine bleeding (DUB) is a condition in which women (usually in their 40’s) have excessively long, heavy or frequent menstrual bleeding for which no demonstrable pathology is found. This exciting international study compared a new oral combined contraceptive pill against a placebo for the treatment of heavy, frequent or prolonged periods.
Objectives of study
This was a randomised placebo controlled study of a combined oral contraceptive pill containing a novel progestogen, Dienogest, and oestradiol valerate, an oestrogen used in hormone replacement therapy.
Before beginning the study participants were given a comprehensive medical check-up including a pap smear, transvaginal ultrasound, endometrial biopsy and a pregnancy test to exclude pathology before being randomised in a 2:1 ratio to treatment or placebo. The study subjects were randomly assigned by computer to either the active study treatment or placebo.
During the study participating women used condoms, kept an electronic menstrual and pill-taking diary and collected all used sanitary protection which was sent to the clinic monthly for measurement of blood loss. Seven months of treatment (including eleven visits to Family Planning NSW) followed a 90-day run-in period.
Published articles
Vaginal epithelial surface appearances in women using vaginal rings for contraception
