Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000617965
Ethics application status
Approved
Date submitted
14/06/2011
Date registered
16/06/2011
Date last updated
16/06/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
New treatments for troublesome bleeding in Implanon users
Scientific title
Comparison of two combined oral contraceptive regimens and an intravaginal hormonal ring against placebo for management of bleeding problems in women using Implanon, the sub-dermal contraceptive implant
Secondary ID [1] 262381 0
Nil
Universal Trial Number (UTN)
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unacceptable bleeding pattern in women using the progestogen-only sub-dermal contraceptive implant 268074 0
Condition category
Condition code
Reproductive Health and Childbirth 268219 268219 0 0
Contraception

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To set up and perform a pilot double-blind randomised clinical Randomised trial of two regimens and an open-label arm to examine the effects of the following treatments on prolonged or frequent uterine bleeding in women using Implanon, the etonogestrel-releasing sub dermal contraceptive implant:

*7 days daily intake of oral capsule containing containing ethinyl oestradiol 30micrograms plus desogestrel 150 micrograms followed by 14 days oral placebo capsules
*21 days daily intake of oral capsules containing ethinyl oestradiol 30micrograms plus desogestrel 150 micrograms
*21 days NuvaRing contraceptive vaginal ring releasing ethinyl oestradiol 15micrograms plus etonorgestrel 120 micrograms dailyleft in situ for 21 days
*21 days daily oral placebo capsules
Treatment will be for one cycle of 21 days
Intervention code [1] 266763 0
Treatment: Drugs
Comparator / control treatment
Control group will take placebo capsules
Comparisons will be made between the three treatment groups against placebo and also against each other
Control group
Placebo

Outcomes
Primary outcome [1] 268960 0
The number of days to stop bleeding after initiation of each treatment group and placebo determined from menstrual diaries completed by subjects
Timepoint [1] 268960 0
Within 3 weeks of starting therapy
Primary outcome [2] 268961 0
*The number of days of bleeding and spotting immediately following initiation of the 7 day Marvelon course of therapy compared with placebo
*The number of bleeding and spotting days immediately following insertion of NuvaRing compared to placebo
*The number of days of bleeding and spotting immediately following initiation of the 21 day Marvelon course of therapy compared with placebo
Timepoint [2] 268961 0
Within 3 weeks of initiating treatment
Secondary outcome [1] 276695 0
The number of days of to stop bleeding following initiation of each therapy compared to the other treatment groups. determined from menstrual diaries
Timepoint [1] 276695 0
Within 3 weeks of initiating treatment
Secondary outcome [2] 276696 0
Comparison of the number of days duration of the first bleeding and spotting-free interval after the initiation of treatment between treatments and placebo determined from menstrual diaries,
Timepoint [2] 276696 0
Within 90 days of starting treatment
Secondary outcome [3] 276697 0
The mean total number of bleeding and spotting days during the 90 day "treatment" reference period compared with the pre-treatment reference period (calculated as percentage reduction) for each group and a comparison between treatment groups and placebo and compared to the other treatment groups determined from menstrual diaries kept for 90 days prior to starting treatment and for 90 days from initiation of treatment.
Timepoint [3] 276697 0
6 months after starting treatment
Secondary outcome [4] 276698 0
The mean number of episodes of bleeding and spotting during the 90 day "treatment" reference period compared with the pre-treatment reference period (calculated as percentage reduction) for each group and a comparison between treatment groups and placebo determined from menstrual diaries kept for 90 days prior to starting treatment and for 90 days from initiation of treatment.
Timepoint [4] 276698 0
3 months after starting treatment
Secondary outcome [5] 276699 0
The mean duration of individual bleeding and spotting episodes in the 90 day "treatment" reference period, compared with pre-treatment reference period (calculated as percentage reduction), and between treatments and placebo determined from menstrual diaries kept for 90 days prior to starting treatment and for 90 days from initiation of treatment.
Timepoint [5] 276699 0
6 months after starting treatment

Eligibility
Key inclusion criteria
*Implanon users, with a complaint of episodes of prolonged (10 days or greater) or frequent bleeding (more than 4 bleeding episodes in a 90 day reference period).
*Women who are willing to participate in a research investigation of new approaches for the management of troublesome bleeding.
*Women who are willing to maintain a 90 day bleeding diary prior to and post treatment initiation.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women who have currently or previously had
*Heart attack or stroke
*Blood clot in a vein
*High blood pressure
*Severe liver or kidney disease
*Blood pressure > 135 mm systolic or >85 mm diastolic
*Migraine with aura
*Breast cancer or any genital cancer
*Severe chronic liver or kidney disease
*Women with known sensitivity to ethinyl oestradiol, progestogens
*Women taking phenytoin, carbamazepine or phenobarbitol
*Women who are pregnant
*Women who are lactating
*Women who are unwilling to keep a daily menstrual diary or otherwise unwilling to follow the study criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
#Implanon users who indicate on a 90 day bleeding diary that they comply with the definition of frequent or prolonged bleeding will be allocated randomly to to one of the three treatment groups or placebo.
The medications will be packed in sequentially numbered and sealed opaque envelopes (independent of the investigators
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed by computer generation of a random number table with equal numbers in each of the four groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The NuvaRing group will be randomly allocated but will not be blinded either to the subject or the investigator. However, the analysis of results willl be blinded.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267246 0
Commercial sector/Industry
Name [1] 267246 0
MSD
Country [1] 267246 0
Australia
Primary sponsor type
Individual
Name
Dr Edith Weisberg
Address
Sydney Centre for Reproductive Health Research
FPNSW
328-336 Liverpool Road
Ashfield
NSW 2131
Country
Australia
Secondary sponsor category [1] 266316 0
Individual
Name [1] 266316 0
Professor Ian Fraser
Address [1] 266316 0
Queen Elizabeth II Research Institute fior Mothers and Babies.
University of Sydney
Camperdown
NSW 2006
Country [1] 266316 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269237 0
Family Planning Ethics Committee
Ethics committee address [1] 269237 0
328-336 liverpool Road

Ashfield
NSW 2131
Ethics committee country [1] 269237 0
Australia
Date submitted for ethics approval [1] 269237 0
07/03/2011
Approval date [1] 269237 0
12/06/2011
Ethics approval number [1] 269237 0
EC00120

Summary
Brief summary
Recruited subjects will maintain a daily menstrual diary chart for a minimum of 90 days, and will be enrolled into the treatment phase provided that they have met one of the World Health Organization criteria for prolonged or frequent bleeding (in the 90 day reference period one episode of bleeding and/or spotting lasting > 10 days, or more than 4 bleeding/spotting episodes)
Following the initial 90 day record, women will begin designated treatment on day 1 of the next episode of bleeding or spotting. Analysis of the subsequent menstrual pattern will begin from day 1 of treatment and will continue through 90 days. Analysis of the pre-treatment menstrual pattern will include the 90 days immediately preceding the bleeding episode in which treatment starts.

Menstrual pattern analysis will be carried out according to World Health Organization definitions and clinically important bleeding pattern criteria.
Trial website
www.fpnsw.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32742 0
Address 32742 0
Country 32742 0
Phone 32742 0
Fax 32742 0
Email 32742 0
Contact person for public queries
Name 15989 0
Sarah Robertson RN
Address 15989 0
Sydney Centre for Reproductive Health Research,
FPNSW
328-336 liverpool Road
Ashfield
NSW
2131
Country 15989 0
Australia
Phone 15989 0
+61 2 8752 4345
Fax 15989 0
+ 61 2 8752 4394
Email 15989 0
sarahr@fpnsw.org.au
Contact person for scientific queries
Name 6917 0
Dr Edith Weisberg
Address 6917 0
Sydney Centre for Reproductive Health Research,
FPNSW
328-336 liverpool Road
Ashfield
NSW
2131
Country 6917 0
Australia
Phone 6917 0
+61 2 8752 4342
Fax 6917 0
+61 2 8752 4394
Email 6917 0
edithw@fpnsw.org.au

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

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Documents added automatically
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