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

Organon and Co0 sites210 target enrollmentNovember 2001

ConditionsContraception

Interventionsetonogestrel implant (Implanon)

Drugsetonogestrel implant (Implanon)

Overview

Phase: Phase 4
Intervention: etonogestrel implant (Implanon)
Conditions: Contraception
Sponsor: Organon and Co
Enrollment: 210
Primary Endpoint: Pregnancy
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2001

End Date

November 2005

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Organon and Co

Responsible Party

Sponsor

Eligibility Criteria

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.