Evaluation of Participant Responses to Educational Counseling About Different Combined Hormonal Contraceptive Choices (P06557) (ECOS)
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|ClinicalTrials.gov Identifier: NCT01181778|
Recruitment Status : Completed
First Posted : August 13, 2010
Results First Posted : September 24, 2013
Last Update Posted : October 21, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Physicians counsel women participants who are candidates for hormonal contraception about available combined hormonal contraceptive methods (the combined pill, the contraceptive vaginal ring [i.e., the etonogestrel + ethinylestradiol vaginal ring] and the contraceptive transdermal patch). Effects of this counseling on women's contraceptive use decisions are to be evaluated by 1) recording which method is chosen after information is provided about all three available combined hormonal methods, 2) comparing the final chosen contraceptive method used by a participant after counseling with the method originally intended to be used by that participant before the counseling, and 3) evaluating the criteria used by women participants to choose their contraceptive method after the counseling, including evaluation of social and demographic predictors of contraceptive choice. The differences among participants in the number of contacts made by the participants to physician offices for purposes of obtaining information regarding the use of their final chosen hormonal contraceptive (e.g., requests for clarification, questions, expressing doubt or reservations for using the method, or requests for other help/advisement by the physician) will also be evaluated over four months following the physician counseling.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1919 participants|
|Official Title:||Observational, Prospective, Multicenter Study to Evaluate the Educational Counseling Effects in the Choice of Different Combined Hormonal Contraceptives|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
All Qualified Participants
All healthy women who consulted their physician for information on contraceptive choices and were eligible for primary and secondary outcome measure analysis, based on the physician's assessment
Primary Outcome Measures :
- Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling [ Time Frame: Day of inclusion (Day 0) prior to physician counseling and after physician counseling ]Before receiving counseling, participants recorded on a questionnaire the method of contraception they thought they would choose. This was to be compared with the method of contraception the same participants thought they would choose after they received physician counseling, which was also recorded on their questionnaire.
Secondary Outcome Measures :
- Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method [ Time Frame: Up to four months after the counseling visit ]Participant contacts with physician offices were collected, and the number of callbacks by method of contraception recorded. Participants who called back more than once were counted overall and for each method of contraception.
No Contacts or Locations Provided