N/A
N=1,919
Evaluation of Participant Responses to Educational Counseling About Different Combined Hormonal Contraceptive Choices (P06557)
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT01181778 ↗Enrolled (actual)
1,919
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling — 1207; 1199; 60; 131 Participants — p=0.705
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Organon and Co
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling |
1207; 1199; 60; 131; 97; 397 | 0.705 |
| SECONDARY Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method |
5.1; 6.9; 6.0; 1.9; 2.5 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01181778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.