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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01181778
First received: August 12, 2010
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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
Contraception

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational, Prospective, Multicenter Study to Evaluate the Educational Counseling Effects in the Choice of Different Combined Hormonal Contraceptives

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 1919
Study Start Date: October 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01181778     History of Changes
Other Study ID Numbers: P06557
Study First Received: August 12, 2010
Results First Received: July 21, 2013
Last Updated: June 16, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by Merck Sharp & Dohme Corp.:
hormonal contraceptive methods
combined hormonal contraceptive methods
physician counseling

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014