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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01715025




Registration number
NCT01715025
Ethics application status
Date submitted
23/10/2012
Date registered
26/10/2012
Date last updated
19/11/2014

Titles & IDs
Public title
A New Treatment Option for Heavy Menstrual Bleeding
Scientific 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)
Secondary ID [1] 0 0
R2012-7
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menorrhagia 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - E2Nomac

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.


Treatment: Drugs: E2Nomac
Women will start the first cycle of the COC on the first day of their period in the treatment phase of the study
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
• The primary efficacy end-point will be the proportion of women with a reduction = 50% from baseline
Timepoint [1] 0 0
Baseline to outcome 12weeks
Secondary outcome [1] 0 0
•• A secondary efficacy endpoint will be the number and proportion of cycles with a normal blood loss = 80mls
Timepoint [1] 0 0
•Baseline to endpoint 12 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2015
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
SCRHR - Sydney
Recruitment postcode(s) [1] 0 0
2131 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Sydney Centre for Reproductive Health Research
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Edith Weisberg, MB BS MM
Address 0 0
Sydney Centre for Reproductive Health Research FPNSW
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Edith Weisberg, MB BS MM
Address 0 0
Country 0 0
Phone 0 0
61 2 8752 4342
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01715025