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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725413
• Other study ID #: P06473
• Secondary ID: E-1729
• Status: Completed
• Phase: Phase 4
• Start date: November 2001
• Est. completion date: November 2005

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• etonogestrel implant (Implanon)
subdermal etonogestrel implant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy		Continuous, recorded at visits conducted every 3 months for the entire trial duration of 3 years.
Primary	(Serious) adverse events		Continuous, recorded at visits conducted every 3 months for the entire trial duration of 3 years.
Secondary	Acceptability (satisfaction questionnaire)		Every 3 months, for the entire duration of the trial