Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001037998
Ethics application status
Approved
Date submitted
13/09/2011
Date registered
4/10/2011
Date last updated
4/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Pericoital oral contraception with levonorgestrel
Scientific title
Pericoital oral contraception with levonorgestrel among reproductive aged-women who have infrequent intercourse to investigate its safety and efficacy
Secondary ID [1] 262807 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fertility regulation 270513 0
Condition category
Condition code
Reproductive Health and Childbirth 268475 268475 0 0
Contraception

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pericoital oral contraception with levonorgestrel 1.5 mg within 24 hours of each act of intercourse over 6.5 months
Intervention code [1] 269155 0
Treatment: Drugs
Intervention code [2] 269447 0
Prevention
Comparator / control treatment
single-arm study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269395 0
pregnancy as assessed by hCG testing
Timepoint [1] 269395 0
monthly for 6.5 months
Primary outcome [2] 279597 0
safety as assessed by serum hemoglobin testing and occurrence of adverse events (adverse events are any sign, symptom, syndrome, or illness such as headaches, nausea, changes in vaginal bleeding, etc. that appears or worsens in a subject during the study which may impair well-being). Adverse events will be measured by asking subjects on a one-monthly basis about any new or worsening health conditions.
Timepoint [2] 279597 0
monthly for 6.5 months
Primary outcome [3] 279598 0
acceptability as assessed by subject questionnaires and interviews
Timepoint [3] 279598 0
monthly for 6.5 months
Secondary outcome [1] 294009 0
Nil
Timepoint [1] 294009 0
Nil

Eligibility
Key inclusion criteria
Reproductive aged-women having sex 1-6 times per month who are at low risk for sexually transmitted infections (STIs), have no contraindications to progestin-only oral contraceptives, have no serious contraindications to pregnancy, and are willing to use an investigational method of contraception as their only contraceptive method for 6.5 months.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy, known allergy to levonorgestrel, indication of subfecundity, contraindications to progestins, breast mass, personal or family history of thrombosis, serious contraindication to pregnancy, currently taking drugs which interfere with progestin contraceptive efficacy.

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)
Since it is a single-arm study, there is no allocation to treatment. Women interested in the study and meeting inclusion and exclusion criteria will be enrolled and will receive the study drug
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
none
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 2210 0
Singapore
State/province [1] 2210 0
Country [2] 2211 0
Thailand
State/province [2] 2211 0
Country [3] 2212 0
Hungary
State/province [3] 2212 0
Country [4] 2213 0
Brazil
State/province [4] 2213 0
Country [5] 2214 0
Tunisia
State/province [5] 2214 0

Funding & Sponsors
Funding source category [1] 269629 0
Other
Name [1] 269629 0
World Health Organization
Country [1] 269629 0
Switzerland
Primary sponsor type
Other
Name
World Health Organization
Address
Avenue Appia, 20 Geneva 27 1211
Country
Switzerland
Secondary sponsor category [1] 266660 0
None
Name [1] 266660 0
Address [1] 266660 0
Country [1] 266660 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271795 0
WHO Ethical Review Committee
Ethics committee address [1] 271795 0
Avenue Appia, 20 Geneva 27
1211
Ethics committee country [1] 271795 0
Switzerland
Date submitted for ethics approval [1] 271795 0
Approval date [1] 271795 0
27/07/2011
Ethics approval number [1] 271795 0

Summary
Brief summary
This is a study of contraception for women who have infrequent intercourse of an oral medication which is taken each time a woman has sex. The objectives of the study are: to evaluate the efficacy of the study regimen among women who expect to have sex 1-6 days a month and who are relying on the study regimen as their primary method of contraception; to evaluate the safety of this regimen, with particular emphasis on its effects on vaginal bleeding patterns and anemia; and to evaluate the acceptability of the regimen among women using it.
Trial website
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 30352 0
Address 30352 0
Country 30352 0
Phone 30352 0
Fax 30352 0
Email 30352 0
Contact person for public queries
Name 13599 0
Nathalie Kapp
Address 13599 0
Avenue Appia 20 Geneva 27
1211
Country 13599 0
Switzerland
Phone 13599 0
+41 22 791 3437
Fax 13599 0
Email 13599 0
[email protected]
Contact person for scientific queries
Name 4527 0
Nathalie Kapp
Address 4527 0
Avenue Appia 20 Geneva 27
1211
Country 4527 0
Switzerland
Phone 4527 0
+41 22 791 3437
Fax 4527 0
Email 4527 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
SourceTitleYear of PublicationDOI
Dimensions AIA prospective, open-label, single arm, multicentre study to evaluate efficacy, safety and acceptability of pericoital oral contraception using levonorgestrel 1.5 mg2016https://doi.org/10.1093/humrep/dev341
N.B. These documents automatically identified may not have been verified by the study sponsor.