Contraceptive trial in healthy young women in which the use of a radiopaque etonogestrel implant inserted with a next generation applicator is evaluated.

An open-label, non-controlled multicentre trial to evaluate the insertion characteristics of the radiopaque etonogestrel implant using a next generation applicator.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000556448

Enrollment

300

Registered

2007-10-29

Start date

2007-04-23

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Radiopaque Etonogestrel Implant for three years, no control treatment.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Healthy volunteers

Yes

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.

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.

Outcome results