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A New Treatment Option for Heavy Menstrual Bleeding

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ClinicalTrials.gov Identifier: NCT01715025
Recruitment Status : Unknown
Verified November 2012 by Sydney Centre for Reproductive Health Research.
Recruitment status was:  Recruiting
First Posted : October 26, 2012
Last Update Posted : November 19, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment Phase
Menorrhagia Drug: E2Nomac Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : April 2013
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: Zoely


Outcome Measures

Primary Outcome Measures :
  1. • The primary efficacy end-point will be the proportion of women with a reduction ≥ 50% from baseline [ Time Frame: Baseline to outcome 12weeks ]
    A single arm open label intervention study


Secondary Outcome Measures :
  1. •• 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 ]
    Open label single group measuring the efficacy of a combined hormonal contraceptive to restore a normal level of MBL


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Recruiting
Sydney, New South Wales, Australia, 2131
Principal Investigator: Edith Weisberg, MB BS MM         
Sponsors and Collaborators
Sydney Centre for Reproductive Health Research
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Edith Weisberg, MB BS MM Sydney Centre for Reproductive Health Research FPNSW
More Information

Publications:
Responsible Party: Sydney Centre for Reproductive Health Research
ClinicalTrials.gov Identifier: NCT01715025     History of Changes
Other Study ID Numbers: R2012-7
First Posted: October 26, 2012    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2012

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
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female