A New Treatment Option for Heavy Menstrual Bleeding

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open-labeled Pilot Study to Determine the Efficacy of an E2//Nomegestrol Acetate (E2/NOMAC)Combination Oral Contraceptive (COC) in the Management of Heavy Menstrual Bleeding (HMB)

Conditions
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Menorrhagia

Intervention / Treatment
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* Drug: E2Nomac


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E2/Nomac<br>Women with demonstrated HMB at baseline will be assigned to 3 cycles of a E2/Nomac combined pill 1 daily for 24 days followed by 1 placebo pill daily for 4 days per cycle. | Drug: E2Nomac<br>* Women will start the first cycle of the COC on the first day of their period in the treatment phase of the study<br>* Other names: Zoely;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • The primary efficacy end-point will be the proportion of women with a reduction ≥ 50% from baseline | A single arm open label intervention study | Baseline to outcome 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| •• 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 | •Baseline to endpoint 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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measured, heavy menstrual bleeding, combined oral contraceptive, alkaline haematin method