A Study to Investigate the Contraceptive Efficacy and Safety of a Subdermal Etonogestrel Implant (Implanon®)(P06473)(COMPLETED)

A Study to Investigate the Contraceptive Efficacy and Safety of a Subdermal Etonogestrel Implant (Implanon®)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00725413

Enrollment

210

Registered

2008-07-30

Start date

2001-11-30

Completion date

2005-11-30

Last updated

2022-02-04

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

Conditions

Contraception

Brief summary

The primary purpose of this study is to investigate the contraceptive efficacy, safety and acceptability of Organon's subdermal etonogestrel implant in healthy female volunteers in various countries in order to obtain country-specific data.

Interventions

DRUGetonogestrel implant (Implanon)

subdermal etonogestrel implant

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Eligible subjects are healthy premenopausal women requiring a long-term method of contraception, with a body mass index between 18 and 29 kg/m2, who are willing to give voluntary written informed consent. Subjects must have regular cycles with a usual length between 24 and 35 days.

Exclusion criteria

* Male * Postmenopause * Infertile * Under 18; Over 40

Design outcomes

Primary

Measure	Time frame
Pregnancy	Continuous, recorded at visits conducted every 3 months for the entire trial duration of 3 years.
(Serious) adverse events	Continuous, recorded at visits conducted every 3 months for the entire trial duration of 3 years.

Secondary

Measure	Time frame
Acceptability (satisfaction questionnaire)	Every 3 months, for the entire duration of the trial

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026