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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - A single arm open label intervention study
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 - Open label single group measuring the efficacy of a combined hormonal contraceptive to restore a normal level of MBL
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
Gender
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
N/A
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 status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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 Corp.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01715025
Trial related presentations / publications
Fraser IS, Römer 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.
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
edithw@fpnsw.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01715025