UCON
Research type
Research Study
Full title
Ulipristal acetate versus conventional management of heavy menstrual bleeding (HMB; including uterine fibroids): a randomised controlled trial and exploration of mechanism of action (UCON trial)
IRAS ID
145282
Contact name
Vikki Young
Contact email
Sponsor organisation
University of Edinburgh
Eudract number
2014-003408-65
Research summary
Research Summary
BACKGROUND: The definitive treatment for the subjective symptom of heavy menstrual bleeding(HMB) has traditionally been surgery. There is a pressing need to develop safe, simple, acceptable, fertility-sparing medical treatments for HMB applicable to women regardless of age, reproductive history and the presence of uterine fibroids. Limitations of current medical treatments are that they are ineffective or associated with side-effects that women find unacceptable. An exciting new class of drugs, called selective progesterone receptor modulators (SPRMs), offer the potential to revolutionise the way we treat HMB by addressing the unmet need of sustainable long-term medical therapy. Menstrual disorder impacts significantly on quality of life, which can be assessed using one of a number of well validated questionnaires.
HYPOTHESIS AND AIMS: We aim to test the hypothesis that the SPRM, ulipristal acetate (UPA; Esmya®), is more effective than the levonorgestrel-releasing intra-uterine system (LNG-IUS, Mirena®) for the long-term treatment of HMB. Further, we aim to acquire an understanding of the mechanism of action of UPA on the endometrium and its effects upon the vasculature and structure of the uterus.
Summary of Results
What is the problem?
Heavy menstrual bleeding is a common condition which affects the lives of many women. A hormone-releasing coil, fitted inside the womb, is effective in making periods lighter but can make them less regular. A medicine called ulipristal acetate, taken as a pill has been shown to reduce rapidly menstrual bleeding in women with large, non-cancerous tumours in the womb, known as fibroids. It was not known whether UPA is effective in women who have heavy periods but do not have fibroids of any significant size.
What did we plan to do?
To find out which treatment was better at controlling heavy periods, 236 women were enrolled in a clinical trial where they received either the hormone coil or ulipristal acetate. The choice of treatment was made at random by a computer rather than the wishes of researchers or patients, to ensure a fair comparison. Participants completed questionnaires about their symptoms and life quality at intervals up to a year.
Twice during the trial, medicines regulatory authorities raised safety concerns about UPA causing liver problems. This resulted in the introduction of regular blood tests. The second time recruitment to the trial stopped early.
What did we find?
Both treatments improved the symptoms of heavy menstrual bleeding in the majority of women. We found no evidence that ulipristal acetate was better overall after a year of treatment, compared to hormone coil, although fewer women on ulipristal acetate continued to have periods. Laboratory studies on samples taken from the lining of the womb showed temporary changes due to UPA which disappeared after treatment stopped.
What does this mean?
Both treatments improve the symptoms of menstrual bleeding and general wellbeing. Due to safety concerns ulipristal acetate is not available for all women with heavy menstrual bleeding and new, safer medical treatments are needed.REC name
London - Bloomsbury Research Ethics Committee
REC reference
14/LO/1602
Date of REC Opinion
25 Sep 2014
REC opinion
Favourable Opinion