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

NCT01181778 | Completed Results

• 1 other identifier: P06557
• Study Type: observational
• Target: 1,919
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Contraception

Keywords

hormonal contraceptive methods; combined hormonal contraceptive methods; physician counseling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method

  Up to four months after the counseling visit

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 26329464 RESULT

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 13, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 4, 2022
• Results First Posted: September 24, 2013

Record last verified: 2022-02