ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

fertility regulation

Condition category

Condition code

Reproductive Health and Childbirth

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]

Treatment: Drugs

Intervention code [2]

Prevention

Comparator / control treatment

single-arm study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

pregnancy as assessed by hCG testing

Timepoint [1]

monthly for 6.5 months

Primary outcome [2]

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]

monthly for 6.5 months

Primary outcome [3]

acceptability as assessed by subject questionnaires and interviews

Timepoint [3]

monthly for 6.5 months

Secondary outcome [1]

Nil

Timepoint [1]

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]

Singapore

State/province [1]

Country [2]

Thailand

State/province [2]

Country [3]

Hungary

State/province [3]

Country [4]

Brazil

State/province [4]

Country [5]

Tunisia

State/province [5]

Funding & Sponsors

Funding source category [1]

Other

Name [1]

World Health Organization

Address [1]

Avenue Appia, 20 Geneva 27 1211

Country [1]

Switzerland

Primary sponsor type

Other

Name

World Health Organization

Address

Avenue Appia, 20 Geneva 27 1211

Country

Switzerland

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

WHO Ethical Review Committee

Ethics committee address [1]

Avenue Appia, 20 Geneva 27
1211

Ethics committee country [1]

Switzerland

Date submitted for ethics approval [1]

Approval date [1]

27/07/2011

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Nathalie Kapp

Address

Avenue Appia 20 Geneva 27
1211

Country

Switzerland

Phone

+41 22 791 3437

Fax

[email protected]

Contact person for scientific queries

Name

Nathalie Kapp

Address

Avenue Appia 20 Geneva 27
1211

Country

Switzerland

Phone

+41 22 791 3437

Fax

[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

Source	Title	Year of Publication	DOI
Dimensions AI	A prospective, open-label, single arm, multicentre study to evaluate efficacy, safety and acceptability of pericoital oral contraception using levonorgestrel 1.5 mg	2016	https://doi.org/10.1093/humrep/dev341

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically