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A New Treatment Option for Heavy Menstrual Bleeding

This study is not yet open for participant recruitment.
Verified October 2012 by Sydney Centre for Reproductive Health Research
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Sydney Centre for Reproductive Health Research
ClinicalTrials.gov Identifier:
NCT01715025
First received: October 23, 2012
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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 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.


Condition Intervention Phase
Menorrhagia
 Drug: E2Nomac combined oral contraceptive
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Menstruation
U.S. FDA Resources

Further study details as provided by Sydney Centre for Reproductive Health Research:

Primary Outcome Measures:
  • • The primary efficacy end-point will be the proportion of women with a reduction ≥ 50% from baseline [ Time Frame: Baseline to outcome 12weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: •Baseline to endpoint 12 weeks ] [ Designated as safety issue: No ]
    Open label single group measuring the efficacy of a combined hormonal contraceptive to restore a normal level of MBL


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E2Nomac combined oral contraceptive
Women with demonstrated HMB at baseline will be assigned to 3 cycles of a 24/4 day E2Nomac combined pill.
 Drug: E2Nomac combined oral contraceptive
Women will start the first cycle of the COC on the first day of their period in the treatment phase of the study
Other Name: Zoely

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715025

Contacts
Contact: Edith Weisberg, MB BS MM 61 2 8752 4342 edithw@fpnsw.org.au
Contact: Jane Hangan, RN 61 409 091 511 janeh@fpnsw.org.au

Locations
Australia, New South Wales
SCRHR Not yet recruiting
Sydney, New South Wales, Australia, 2131
Principal Investigator: Edith Weisberg, MB BS MM            
Sponsors and Collaborators
Sydney Centre for Reproductive Health Research
Merck
Investigators
Principal Investigator: Edith Weisberg, MB BS MM Sydney Centre for Reproductive Health Research FPNSW
  More Information

No publications provided

Responsible Party: Sydney Centre for Reproductive Health Research
ClinicalTrials.gov Identifier: NCT01715025     History of Changes
Other Study ID Numbers: R2012-7
Study First Received: October 23, 2012
Last Updated: October 29, 2012
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Sydney Centre for Reproductive Health Research:
measured
heavy menstrual bleeding
combined oral contraceptive
alkaline haematin method

Additional relevant MeSH terms:
Hemorrhage
Menorrhagia
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Contraceptive Agents
 Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on June 17, 2013