Women with measured menstrual bleeding \>80ml per cycle and no contraindications to combined oral contraceptive use will be assigned to an oestradiol/nomegestrol acetate oral contraceptive for 3 cycles during which they will collect all menstrual blood and send all used sanitary protection to the laboratory at the University of Sydney for estimation of blood loss by the alkaline haematin method. Hypothesis: An estradiol/nomogestrel acetate (E2/NOMAC) combined pill will be effective in controlling HMB in the majority of women without structural pelvic pathology. Main outcome: The primary efficacy end-point will be the proportion of women with a reduction of menstrual blood loss ≥ 50% from baseline.
Women will collect menstrual blood for 3 cycles and will be eligible to enter the treatment phase if in two of the three pre-treatment cycles the measured menstrual blood loss (MBL)is \>80ml. The mean of these baseline MBL measurements will be the comparator for the efficacy treatment measurement. Iron studies (serum ferritin, Fe and transferrin) will also be measured pre and post treatment and related to women's assessment of their quality of life measured on a validated questionnaire.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Women will start the first cycle of the COC on the first day of their period in the treatment phase of the study
SCRHR
Sydney, New South Wales, Australia
RECRUITING• The primary efficacy end-point will be the proportion of women with a reduction ≥ 50% from baseline
A single arm open label intervention study
Time frame: Baseline to outcome 12weeks
•• A secondary efficacy endpoint will be the number and proportion of cycles with a normal blood loss ≤ 80mls
Open label single group measuring the efficacy of a combined hormonal contraceptive to restore a normal level of MBL
Time frame: •Baseline to endpoint 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.