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

NCT ID: NCT00725413

Last Updated: 2022-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-30
• Study Completion Date: 2005-11-30

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.

Conditions

Contraception

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Healthy premenopausal women requiring a long-term method of contraception

Group Type: EXPERIMENTAL

etonogestrel implant (Implanon)

Intervention Type: DRUG

subdermal etonogestrel implant

Interventions

etonogestrel implant (Implanon)

subdermal etonogestrel implant

Intervention Type: DRUG

Other Intervention Names

Org 3236

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.

Exclusion Criteria

• Male
• Postmenopause
• Infertile
• Under 18; Over 40

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

E-1729

Identifier Type: -

Identifier Source: secondary_id

P06473

Identifier Type: -

Identifier Source: org_study_id