Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000206628
Ethics application status
Approved
Date submitted
15/08/2005
Date registered
25/08/2005
Date last updated
25/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Control of menstrual bleeding disturbances in women using Implanon contraception
Scientific title
Randomised controlled trial of five treatments for women with breakthrough bleeding while using Implanon hormonal contraception to treat breakthrough bleeding (treatments options: placebo; mifepristone plus ethinyl oestradiol; doxycycline; doxycycline plus ethinyl oestradiol; doxycycline plus mifepristone)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breakthrough bleeding with Implanon progestogen-only contraception 287 0
Condition category
Condition code
Reproductive Health and Childbirth 324 324 0 0
Contraception

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised, controlled, double-blind trial of the effectiveness of four active treatments and placebo in the management of episodes of breakthrough bleeding in women using the progestogen-only, sub dermal implant contraceptive, Implanon. Implanon provides the near-zero-order release of the progestogen, etonogestrel, over a three year period. Treatment will be randomised to one of five arms. Each treatment will be given twice daily for 5 days in a complex arrangement which allows the following measurements:

1 Mifepristone 25mgs taken twice on day 1 followed by 4 days of ethinyl oestradiol, 20 micrograms each morning and placebo each evening.
2 Doxycycline 100mgs taken twice daily for 5 days.
3 Doxycycline 100mg plus ethinyl oestradiol 20 micrograms in the morning, and doxycycline 100 mg in the evening, for 5 days.
4 Doxycycline 100mg plus mifepristone 25mg twice on the first day and then doxycycline 100 mg taken twice daily for 4 days.
Each of these blinded treatments will be taken once a month for 3 months.
Intervention code [1] 189 0
None
Comparator / control treatment
Placebo twice daily for 5 days.
Control group
Placebo

Outcomes
Primary outcome [1] 379 0
The time taken for an episode of bleeding to cease following initiation of treatment, compared with placebo.
Timepoint [1] 379 0
Assessed at the first treatment.
Secondary outcome [1] 842 0
There are 6 secondary end points which study the number of days of bleeding and spotting immediately following the initiation of the 5 day course of therapy, compared with the other 3 active therapies.
Timepoint [1] 842 0
Comparisons will also be made with the total number of days, episodes and duration of bleeding within the successive 90 day "reference period" following the initiation of treatment. Comparisons will be made with placebo and with the other 3 active therapies.
Secondary outcome [2] 843 0
All adverse events will be recorded.
Timepoint [2] 843 0

Eligibility
Key inclusion criteria
Implanon users, with a complaint of episodes of prolonged (7 days or greater) or frequent (bleeding-free intervals of less than 15 days) bleeding. Women who are willing to participate in a research investigation of new approaches to the therapy of breakthrough bleeding.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with contraindications to the use of oestrogen, anti-progesterone or tetracycline therapy; women with allergy to lactose; 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)
Identical opaque gelatin capsules will be assigned and presented in identical foil blister packs in sealed numbered envelopes. Sealed master envelopes have been prepared by the blister pack manufacturer and sent directly to the Data and Safety Monitoring Board and to the Chief Executive Officer of FPA Health. The treatment codes will only be broken following completion of the analysis of the primary end point. Therefore, allocation concealment will be maintained until the end of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generation of a random number table for each centre, in blocks with equal numbers in the 5 treatment groups (generated by an independent statistician) and placed in sequentially numbered and sealed envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 383 0
Government body
Name [1] 383 0
National Institutes of Health
Country [1] 383 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
FPA Health, 328 Liverpool Rd Ashfield NSW 2131
Address
Country
Australia
Secondary sponsor category [1] 310 0
Hospital
Name [1] 310 0
King Edward Memorial Hospital
Address [1] 310 0
Perth
Subiaco WA
Country [1] 310 0
Australia
Secondary sponsor category [2] 311 0
Hospital
Name [2] 311 0
Royal Women's Hospital
Address [2] 311 0
Swanston St
Melbourne VIC
Country [2] 311 0
Australia
Secondary sponsor category [3] 312 0
University
Name [3] 312 0
University of Queensland
Address [3] 312 0
Brisbane QLD
Country [3] 312 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35721 0
Address 35721 0
Country 35721 0
Phone 35721 0
Fax 35721 0
Email 35721 0
Contact person for public queries
Name 9378 0
Dr Edith Weisberg
Address 9378 0
Sydney Centre for Reproductive Health Research
Family Planning Australia Health
328 Liverpool Rd
Ashfield NSW 2131
Country 9378 0
Australia
Phone 9378 0
+61 2 87524342
Fax 9378 0
+61 2 97165134
Email 9378 0
edith
Contact person for scientific queries
Name 306 0
Professor Ian Fraser
Address 306 0
Department of Obstetrics and Gynaecology
University of Sydney
Building D02
Camperdown NSW 2006
Country 306 0
Australia
Phone 306 0
+61 2 93512478
Fax 306 0
+61 2 93514560
Email 306 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.