Trial | NCT01715025  Report issue

Title

A New Treatment Option for Heavy Menstrual Bleeding
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)

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    30
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 Started
Apr 30
2013
Primary Completion
Apr 30
2015
Anticipated
Study Completion
Aug 31
2015
Anticipated
Last Update
Nov 19
2014
Estimate

Drug E2Nomac

Women will start the first cycle of the COC on the first day of their period in the treatment phase of the study

  • Other names: Zoely

E2/Nomac Experimental

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.

Criteria 

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
No Results Posted