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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00725413
First received: July 28, 2008
Last updated: February 6, 2015
Last verified: February 2015
  Purpose
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.

Condition Intervention Phase
Contraception
Drug: etonogestrel implant (Implanon)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Investigate the Contraceptive Efficacy and Safety of a Subdermal Etonogestrel Implant (Implanon®)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Pregnancy [ Time Frame: Continuous, recorded at visits conducted every 3 months for the entire trial duration of 3 years. ] [ Designated as safety issue: No ]
  • (Serious) adverse events [ Time Frame: Continuous, recorded at visits conducted every 3 months for the entire trial duration of 3 years. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Acceptability (satisfaction questionnaire) [ Time Frame: Every 3 months, for the entire duration of the trial ] [ Designated as safety issue: No ]

Enrollment: 210
Study Start Date: November 2001
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Healthy premenopausal women requiring a long-term method of contraception
Drug: etonogestrel implant (Implanon)
subdermal etonogestrel implant
Other Name: Org 3236

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00725413     History of Changes
Other Study ID Numbers: P06473  E-1729 
Study First Received: July 28, 2008
Last Updated: February 6, 2015
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Contraceptive Agents
Etonogestrel
Desogestrel
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 28, 2016