Evaluation of Participant Responses to Educational Counseling About Different Combined Hormonal Contraceptive Choices (P06557) (ECOS)

Observational, Prospective, Multicenter Study to Evaluate the Educational Counseling Effects in the Choice of Different Combined Hormonal Contraceptives

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.

Study Overview

• Status: Completed
• Conditions: Contraception

• Study Type: Observational
• Enrollment (Actual): 1919

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Healthy women ≥ 18 years of age and < 40 years of age who consult their physician for information on contraception choices

Description

Inclusion Criteria:

• Healthy women ≥ 18 years of age and ≤ 40 years of age who consult their physician for contraception and would consider a combined hormonal contraceptive method
• Women who are using the hormonal method for the first time or who have previously used and suspended it for at least 1 month
• Women on one combined pill who would consider switching to another combined pill (Women who attend their physician to stop one of the combined hormonal methods can not participate)
• Women who request a combined hormonal contraceptive method but for whom the physician considers another method more appropriate (e.g. contraindications for combined hormonal contraception) will be counseled about these methods but still complete the questionnaire
• Women who are not interested in becoming pregnant in the next 4 months
• Women who agree to complete a questionnaire and that the questionnaire data are reviewed and analyzed by staff participating in the project

Exclusion Criteria:

None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Choosing Each Hormonal Contraceptive Method Before and After 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.	Day of inclusion (Day 0) prior to physician counseling and after physician counseling

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method	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.	Up to four months after the counseling visit

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Gambera A, Corda F, Papa R, Bastianelli C, Bucciantini S, Dessole S, Scagliola P, Bernardini N, de Feo D, Beligotti F. Observational, prospective, multicentre study to evaluate the effects of counselling on the choice of combined hormonal contraceptives in Italy--the ECOS (Educational COunselling effectS) study. BMC Womens Health. 2015 Sep 2;15:69. doi: 10.1186/s12905-015-0226-x.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: August 12, 2010
• First Submitted That Met QC Criteria: August 12, 2010
• First Posted (Estimate): August 13, 2010

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: hormonal contraceptive methods; combined hormonal contraceptive methods; physician counseling
• Other Study ID Numbers: P06557