Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000556448
Ethics application status
Approved
Date submitted
24/10/2007
Date registered
29/10/2007
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Contraceptive trial in healthy young women in which the use of a radiopaque etonogestrel implant inserted with a next generation applicator is evaluated.
Scientific title
An open-label, non-controlled multicentre trial to evaluate the insertion characteristics of the radiopaque etonogestrel implant using a next generation applicator.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contraception 2500 0
Condition category
Condition code
Reproductive Health and Childbirth 2596 2596 0 0
Contraception

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Radiopaque Etonogestrel Implant for three years, no control treatment.
Intervention code [1] 2226 0
Prevention
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3507 0
To evaluate the use of the next generation applicator and its instructions for proper insertion of the Radiopaque Implant.
Timepoint [1] 3507 0
Insertion visit.
Secondary outcome [1] 5856 0
To evaluate the removal of the Radiopaque Implant, to assess overall contraceptive efficay and safety, to assess X-ray visibility of the Radiopaque Implant, to evaluate subject's expactations and satisfaction with the Radiopaque Implant.
Timepoint [1] 5856 0
3 years

Eligibility
Key inclusion criteria
Women 18-40 years, good physical and mental health, having regular menstrual cycles with a usual length between 24 and 35 days and a body mass index between 18 and 35 kg/m2. Subjects who are not willing to give written consent will not be allowed to enter.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Contraindications for contraceptives, hypertension, history during pregnancy or during previous use of of sex steroids of a.o. jaundice, gallstone formation, porphyria, hemolytic uremic syndrome, use of drugs that may interfere with the pharmacokinetics of sex steroids.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
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 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
23/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 633 0
France
State/province [1] 633 0
UK
Country [2] 634 0
Germany
State/province [2] 634 0
Sweden
Country [3] 635 0
Norway
State/province [3] 635 0

Funding & Sponsors
Funding source category [1] 2746 0
Commercial sector/Industry
Name [1] 2746 0
NV Organon
Country [1] 2746 0
Netherlands
Primary sponsor type
Commercial sector/Industry
Name
NV Organon
Address
Molenstraat 110
5342 CC Oss
Country
Netherlands
Secondary sponsor category [1] 2481 0
None
Name [1] 2481 0
Address [1] 2481 0
Country [1] 2481 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4665 0
Southern Health Human Research Ethics Committee
Ethics committee address [1] 4665 0
Ethics committee country [1] 4665 0
Australia
Date submitted for ethics approval [1] 4665 0
21/12/2006
Approval date [1] 4665 0
19/03/2007
Ethics approval number [1] 4665 0
06190C

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

Contacts
Principal investigator
Name 28142 0
Address 28142 0
Country 28142 0
Phone 28142 0
Fax 28142 0
Email 28142 0
Contact person for public queries
Name 11299 0
Mommers, Ellen, PhD
Address 11299 0
P.O. Box 20
5340 BH Oss
Country 11299 0
Netherlands
Phone 11299 0
+31(0)4123712
Fax 11299 0
Email 11299 0
ellen.mommers@organon.com
Contact person for scientific queries
Name 2227 0
Mommers, Ellen, PhD
Address 2227 0
P.O. Box 20
5340 BH Oss
Country 2227 0
Netherlands
Phone 2227 0
+31 (0) 4123712
Fax 2227 0
Email 2227 0
ellen.mommers@organon.com

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.