Research Projects

Unity Dysfunctional Uterine Bleeding Study

Summary An exciting international study comparing a new combined hormonal treatment against placebo for the treatment of heavy, frequent or prolonged periods.

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 study is 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. Women will undergo a transvaginal ultrasound and endometrial biopsy to exclude pathology before being randomised in a 2:1 ratio to treatment or placebo. Women will use condoms during the study and keep an electronic menstrual and pill taking diary and collect all used sanitary protection to be sent to the clinic monthly for measurement of blood loss. There will be a 90-day run in period followed by 7 months of treatment.
 

What to expect

The study subjects will randomly assigned by a computer to either the active study treatment or placebo.

Involvement in the trial will be for approximately seven months and involves eleven visits to Family Planning NSW. You will be given a thorough medical check up including a pap smear, pelvic ultrasound, endometrial biopsy and a pregnancy test. You will be required to keep a menstrual diary and collect all sanitary protection for the study period. Treatment will be for six months.

All tests and treatments are free of charge. All aspects of your participation are completely confidential.

Contact phone     02 8752 4350
Contact email     research@fpnsw.org.au