A New Treatment Option for Heavy Menstrual Bleeding

Phase 4

• Conditions: Menorrhagia
• Interventions: Drug: E2Nomac

• Registration Number: NCT01715025
• Lead Sponsor: Sydney Centre for Reproductive Health Research

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.

Study Timeline

• Study First Submitted: 2012-10-23
• Study First Submitted QC: 2012-10-23
• Study First Posted: 2012-10-26
• Status Verified: 2012-11
• Study Start: 2013-04
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-19
• Primary Completion: 2015-04
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
E2/Nomac	E2Nomac	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.

Primary Outcome Measures

Name	Time	Method
• 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 Outcome Measures

Name	Time	Method
•• 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

Trial Locations

Locations (1)

SCRHR; 🇦🇺 Sydney, New South Wales, Australia