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

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ClinicalTrials.gov Identifier: NCT00725413
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : February 9, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Contraception Drug: etonogestrel implant (Implanon) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Investigate the Contraceptive Efficacy and Safety of a Subdermal Etonogestrel Implant (Implanon®)
Study Start Date : November 2001
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1
Healthy premenopausal women requiring a long-term method of contraception
Drug: etonogestrel implant (Implanon)
subdermal etonogestrel implant
Other Name: Org 3236



Primary Outcome Measures :
  1. Pregnancy [ Time Frame: Continuous, recorded at visits conducted every 3 months for the entire trial duration of 3 years. ]
  2. (Serious) adverse events [ Time Frame: Continuous, recorded at visits conducted every 3 months for the entire trial duration of 3 years. ]

Secondary Outcome Measures :
  1. Acceptability (satisfaction questionnaire) [ Time Frame: Every 3 months, for the entire duration of the trial ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00725413     History of Changes
Other Study ID Numbers: P06473
E-1729
First Posted: July 30, 2008    Key Record Dates
Last Update Posted: February 9, 2015
Last Verified: February 2015

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