Abstract
BackgroundHeavy menstrual bleeding (HMB) exceeding 80 mL per cycle leads to considerable adverse impact on a woman’s iron metabolism, incidence of iron deficiency and anaemia, as well as her functioning in society.The objective of the study is to determine the potential efficacy of a Monophasic oestradiol-17β-nomegestrol acetate (E2/Nomac) combined oral contraceptive pill on measured menstrual blood loss as a pilot study in 12 women with objectively demonstrated HMB (>80 mL per cycle). The pilot study aimed to recruit 20 women.MethodConsented women completed the HMB questionnaire. The blood was taken for haemoglobin, transferrin, iron saturation, TIBC, serum iron and ferritin. Women were given verbal and written detailed instructions for MBL collection for three control cycles and four treatment cycles.ResultsForty-three women were enrolled, but 31 were ineligible and withdrawn (mainly for failure to meet eligibility criteria). Twelve women entered the treatment phase and commenced the E2/nomegestrol acetate (NOMAC) 24/4 combined pill treatment on the first day of their fourth cycle. All women with complete MBL measurements had >50% reduction in MBL on treatment (exact 95% confidence interval for proportion with MBL reduction >50%: 69 to 100%). The mean percent reduction in MBL between pretreatment and during treatment was 76.9%, and the median was 79% with a range of 53.7 to 100%.ConclusionsThis pilot study indicates that the E2/NOMAC COC will provide a useful potential option for treating HMB in women with FIGO classification AUB-E (primary endometrial causes) but requires a larger placebo-controlled study for confirmation.
Highlights
Heavy menstrual bleeding (HMB) exceeding 80 mL per cycle leads to considerable adverse impact on a woman’s iron metabolism, incidence of iron deficiency and anaemia, as well as her functioning in society
The mean percent reduction in menstrual blood loss (MBL) between pretreatment and during treatment was 76.9%, and the median was 79% with a range of 53.7 to 100%. This pilot study indicates that the E2/NOMAC COC will provide a useful potential option for treating HMB in women with FIGO classification AUB-E but requires a larger placebo-controlled study for confirmation
Around half of all women presenting with HMB have no evidence of underlying structural pelvic pathology (i.e. these are women with AUB-E, AUB-O or AUB-C according to the FIGO PALM-COEIN classification of causes of HMB [12])
Summary
Heavy menstrual bleeding (HMB) exceeding 80 mL per cycle leads to considerable adverse impact on a woman’s iron metabolism, incidence of iron deficiency and anaemia, as well as her functioning in society. The impact HMB has on a HMB accounts for considerable morbidity in women of reproductive age and can greatly affect many aspects of their health and quality of life This includes problems of length and heaviness of bleeding, severity of menstrual pain, problems with flooding and clots, problems with soiling, being confined to bed, mood changes, severe lethargy and fatigue, anxiety, psychiatric morbidity, Weisberg et al Pilot and Feasibility Studies (2017) 3:18 iron deficiency and anaemia [4,5,6,7,8,9,10,11]. These women may be suitable for medical treatment with only limited initial investigations
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