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OpenTrials
Completed

NCT Number: NCT00725413

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

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.

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Key information

Conditions

Contraception

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etonogestrel implant (Implanon)

Drug

subdermal etonogestrel implant

Other names: Org 3236

Primary outcomes

  1. Pregnancy

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

  2. (Serious) adverse events

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

Secondary outcomes

  1. Acceptability (satisfaction questionnaire)

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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
Jul 30, 2008
Registry last updated
Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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