Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Organon |
---|---|
Information provided by: | Organon |
ClinicalTrials.gov Identifier: | NCT00620035 |
The primary purpose of this study is to evaluate the use of the next generation applicator and its instructions for proper insertion of the Radiopaque Implant. Secondary objectives include: evaluation of implant removal, evaluation of the overall contraceptive efficacy and safety of the Radiopaque Implant, assessment of x -ray visibility of the Radiopaque Implant, and to assess subject expectations and satisfaction with the Radiopaque Implant.
Condition | Intervention | Phase |
---|---|---|
Contraception |
Drug: Radiopaque Etonogestrel Implant |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Non-Controlled Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator |
Enrollment: | 301 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 1: Active Comparator
Radiopaque Etonogestrel Implant (drug) inserted with the Next Generation Implanon Applicator
|
Drug: Radiopaque Etonogestrel Implant
One implant for 3 years
|
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contraindications:
Responsible Party: | NV Organon, part of Schering-Plough Corporation ( Study Director ) |
Study ID Numbers: | 34530, P05702 |
Study First Received: | February 11, 2008 |
Last Updated: | April 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00620035 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Norway: Norwegian Medicines Agency; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Desogestrel Contraceptive Agents Contraceptive Agents, Female 3-keto-desogestrel |
Contraceptive Agents Therapeutic Uses Physiological Effects of Drugs Contraceptive Agents, Female |
Reproductive Control Agents 3-keto-desogestrel Pharmacologic Actions |