UCON

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Study details

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

Short Title:
UCON

Aims of the study: 
Determine if Ulipristal Acetate (UPA) is more effective at reducing the burden of Heavy Menstrual Bleeding (HMB) symptoms than Levonorgestrel intrauterine system (LNG-IUS) after 12 months of treatment.

Study design: 
A multicentre, randomised controlled trial of UPA compared to LNG-IUS with a concurrent mechanistic evaluation of UPA.

Study Duration: 
The original accrual was 24 months and followed up for 12 months. The trial recruitment was temporarily halted*. The trial re-opened to recruitment in October 2018 and is scheduled to complete in September 2019.

Sample size:
302

Timeframes:
NIHR EME grant start date 1st October 2014. Grant end date 31st May 2021. All participants will be followed up for 12 months. Recruitment lasted 48 months (inclusive of 7 months where the recruitment was temporarily halted). 5 months has been allocated for data analysis and report writing. The final report is expected to be submitted to the funder approximately June 2021.

* Ulipristal was under investigation by the European Medicines Agency (EMA) from December 2017 and was temporarily suspended and not allowed to be prescribed. Eight reports of serious liver injury were reported in Europe in an estimated 740,000 women using ulipristal for uterine fibroids. It is still unclear whether the use of ulipristal led to these liver problems or there were underlying reasons. However, in order to safeguard patients, recommendations have been issued that women who are take ulipristal should have blood tests taken at least once a month to check their liver function. In May 2018 and August 2018, the EMA and UK Medicines and Healthcare Products Regulatory Authority (MHRA) allowed use of ulipristal.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Esmya/human_referral_prac_000070.jsp&mid=WC0b01ac05805c516f

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Chief Investigator: Professor Hilary Critchley

Trial Co-Sponsors: University of Edinburgh/ NHS Lothian

Funding: Medical Research Council (MRC) and National Institute for Health Research (NIHR) -   Efficacy and Mechanism Evaluation (EME) programme (Ref 12/206/52)

NRES Committee: London Bloomsbury (REC No: 14/LO/1602

ISRCTN: 20426843

UKCRN Portfolio ID: 18534

UCON Protocol v6.0 6th September 2018