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

Phase 4

Completed

• Conditions: Contraception
• Interventions: Drug: etonogestrel implant (Implanon)

• Registration Number: NCT00725413
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Study First Submitted: 2008-07-28
• Study First Submitted QC: 2008-07-29
• Study First Posted: 2008-07-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	etonogestrel implant (Implanon)	Healthy premenopausal women requiring a long-term method of contraception

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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