Long term follow up of ECLIPSE trial cohort
Research type
Research Study
Full title
Medical treatment of heavy menstrual bleeding in primary care: Long term follow up of ECLIPSE trial cohort
IRAS ID
184745
Contact name
Joe Kai
Contact email
Sponsor organisation
University of Nottingham
Duration of Study in the UK
3 years, 0 months, 31 days
Research summary
The original ECLIPSE trial compared the success of women starting two different treatment approaches when they saw their general practitioner with heavy menstrual bleeding (HMB). Women agreed to be randomly allocated to either taking ‘standard’ medical treatments (such as oral mefenamic acid, tranexamic acid tablets or the contraceptive pill) or having a contraceptive ‘coil’ inserted, called levonorgesterel intrauterine system or ‘LNG-IUS.’The trial findings were published at two and five years showing both types of treatment helped. This ‘follow up’ study will try to collect information from those women who participated in the trial 10 years after they started - when their average age was 42 years. As the menopause usually starts around the age of 52, most will be approaching natural menopause, making it timely to find out if and how women still continued treatments, and whether more women still had to have surgery. With women’s consent, we will seek this information by questionnaire and also from their GP records. We will also interview a smaller sample of women in more detail about their experiences of using or deciding to stop or change treatments for this problem, and how these may change over time (such as changing need for contraception or wanting to conceive later in life). The results of the study will provide very useful long-term information on what happens to women who seek help and are treated for heavy menstrual bleeding in general practice. This information could help women and health professionals in making more informed choices about help for this condition at its outset, according to women’s differing preferences and circumstances, what to expect from different treatments, or knowing what proportion of women may still require surgery over time.
REC name
London - Chelsea Research Ethics Committee
REC reference
17/LO/1876
Date of REC Opinion
27 Oct 2017
REC opinion
Favourable Opinion