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

Organon and Co210 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

210

Conditions

Contraception

Interventions

etonogestrel implant (Implanon)DRUG

subdermal etonogestrel implant

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pregnancy

Time frame: Continuous, recorded at visits conducted every 3 months for the entire trial duration of 3 years.

(Serious) adverse events

Time frame: Continuous, recorded at visits conducted every 3 months for the entire trial duration of 3 years.

Secondary Outcomes

Acceptability (satisfaction questionnaire)

Time frame: Every 3 months, for the entire duration of the trial

Data from ClinicalTrials.gov

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