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)

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.

Study Overview

• Status: Unknown
• Conditions: Menorrhagia
• Intervention / Treatment: Drug: E2Nomac

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Edith Weisberg, MB BS MM; Phone Number: 61 2 8752 4342; Email: edithw@fpnsw.org.au
• Study Contact Backup: Name: Jane Hangan, RN; Phone Number: 61 409 091 511; Email: janeh@fpnsw.org.au

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2131
      • Recruiting
      • SCRHR
      • Principal Investigator: Edith Weisberg, MB BS MM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E2/Nomac; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sydney Centre for Reproductive Health Research
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Edith Weisberg, MB BS MM, Sydney Centre for Reproductive Health Research FPNSW

Publications and helpful links

General Publications

• Fraser IS, Romer T, Parke S, Zeun S, Mellinger U, Machlitt A, Jensen JT. Effective treatment of heavy and/or prolonged menstrual bleeding with an oral contraceptive containing estradiol valerate and dienogest: a randomized, double-blind Phase III trial. Hum Reprod. 2011 Oct;26(10):2698-708. doi: 10.1093/humrep/der224. Epub 2011 Jul 21.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: October 23, 2012
• First Submitted That Met QC Criteria: October 23, 2012
• First Posted (Estimate): October 26, 2012

Study Record Updates

• Last Update Posted (Estimate): November 19, 2014
• Last Update Submitted That Met QC Criteria: November 17, 2014
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: measured; heavy menstrual bleeding; combined oral contraceptive; alkaline haematin method
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Menstruation Disturbances; Uterine Hemorrhage; Hemorrhage; Menorrhagia
• Other Study ID Numbers: R2012-7