Menorrhagia
Conditions
Keywords
measured, heavy menstrual bleeding, combined oral contraceptive, alkaline haematin method
Brief summary
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.
Detailed description
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.
Interventions
DRUGE2Nomac
Women will start the first cycle of the COC on the first day of their period in the treatment phase of the study
Sponsors
Merck Sharp & Dohme LLC
Sydney Centre for Reproductive Health Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Women aged 18-50 years having regular menstrual cycles * Women willing to collect all sanitary protection for 6 cycles * Women with no contraindications to use of combined hormonal contraception * Women not using any hormonal contraception or any treatment for HMB * Women who have no demonstrable uterine pathology on pelvic ultrasound * Women who have demonstrated a menstrual blood loss (MBL) \>80mls in 2 of 3 menstrual periods during the pre-treatment phase will be eligible to enter the treatment phase
Exclusion criteria
* Women for whom combined oral contraceptives are contraindicated * Women unwilling to collect all sanitary protection for 6 cycles * Women using hormonal contraception or any treatment for HMB * Women who have demonstrable uterine pathology on pelvic ultrasound * Women who have demonstrated a MBL ≤80mls in 2 of 3 consecutive menstrual periods
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • The primary efficacy end-point will be the proportion of women with a reduction ≥ 50% from baseline | Baseline to outcome 12weeks | A single arm open label intervention study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| •• A secondary efficacy endpoint will be the number and proportion of cycles with a normal blood loss ≤ 80mls | •Baseline to endpoint 12 weeks | Open label single group measuring the efficacy of a combined hormonal contraceptive to restore a normal level of MBL |
Countries
Australia
Contacts
Primary ContactEdith Weisberg, MB BS MM
Backup ContactJane Hangan, RN
Outcome results
None listed