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A New Treatment Option for Heavy Menstrual Bleeding

Primary Purpose

Menorrhagia

Status
Unknown status
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
E2Nomac
Sponsored by
Sydney Centre for Reproductive Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia focused on measuring measured, heavy menstrual bleeding, combined oral contraceptive, alkaline haematin method

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts 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

Sites / Locations

  • SCRHRRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

E2/Nomac

Arm 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.

Outcomes

Primary Outcome Measures

• The primary efficacy end-point will be the proportion of women with a reduction ≥ 50% from baseline
A single arm open label intervention study

Secondary Outcome Measures

•• 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

Full Information

First Posted
October 23, 2012
Last Updated
November 17, 2014
Sponsor
Sydney Centre for Reproductive Health Research
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01715025
Brief Title
A New Treatment Option for Heavy Menstrual Bleeding
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sydney Centre for Reproductive Health Research
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia
Keywords
measured, heavy menstrual bleeding, combined oral contraceptive, alkaline haematin method

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
E2/Nomac
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
E2Nomac
Other Intervention Name(s)
Zoely
Intervention Description
Women will start the first cycle of the COC on the first day of their period in the treatment phase of the study
Primary Outcome Measure Information:
Title
• The primary efficacy end-point will be the proportion of women with a reduction ≥ 50% from baseline
Description
A single arm open label intervention study
Time Frame
Baseline to outcome 12weeks
Secondary Outcome Measure Information:
Title
•• A secondary efficacy endpoint will be the number and proportion of cycles with a normal blood loss ≤ 80mls
Description
Open label single group measuring the efficacy of a combined hormonal contraceptive to restore a normal level of MBL
Time Frame
•Baseline to endpoint 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edith Weisberg, MB BS MM
Phone
61 2 8752 4342
Email
edithw@fpnsw.org.au
First Name & Middle Initial & Last Name or Official Title & Degree
Jane Hangan, RN
Phone
61 409 091 511
Email
janeh@fpnsw.org.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edith Weisberg, MB BS MM
Organizational Affiliation
Sydney Centre for Reproductive Health Research FPNSW
Official's Role
Principal Investigator
Facility Information:
Facility Name
SCRHR
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2131
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edith Weisberg, MB BS MM

12. IPD Sharing Statement

Citations:
PubMed Identifier
21784734
Citation
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.
Results Reference
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A New Treatment Option for Heavy Menstrual Bleeding

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