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

Organon

Status and phase: Completed; Phase 4

Conditions: Contraception

Treatments: Drug: etonogestrel implant (Implanon)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00725413

P06473

E-1729

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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210 participants in 1 patient group

Arm 1

Experimental group

Description:

Healthy premenopausal women requiring a long-term method of contraception

Treatment:

Drug: etonogestrel implant (Implanon)