A New Treatment Option for Heavy Menstrual Bleeding

Sydney Centre for Reproductive Health Research

Status and phase: Unknown; Phase 4

Conditions: Menorrhagia

Treatments: Drug: E2Nomac

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01715025

R2012-7

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

E2/Nomac

Experimental group

Description:

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.

Treatment:

Drug: E2Nomac