Post-marketing, Observational Study to Confirm the Safety and Efficacy of MARVELON (Study P06083)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01005056|
Recruitment Status : Completed
First Posted : October 30, 2009
Last Update Posted : April 29, 2015
The purpose of this study is to evaluate the efficacy and safety of Marvelon® in the prevention of pregnancy.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
|Condition or disease||Intervention/treatment|
|Contraception||Drug: Ethinylestradiol + Desogestrel|
|Study Type :||Observational|
|Actual Enrollment :||3838 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Drug Use Investigation of MARVELON|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
Single arm study. All participants receive Marvelon® according to the approved dosage and administration method.
Drug: Ethinylestradiol + Desogestrel
All participants receive Marvelon® according to the approved dosage and administration method.
- Number of participants who did not get pregnant during the study. [ Time Frame: End of every 12 menstrual cycles up to 36 or at the termination of drug administration. ]