Clinical trial NCT01181778: Evaluation of Participant Responses to Educational Counseling About Different Combined Hormonal Contraceptive Choices (P06557)
Official title: Observational, Prospective, Multicenter Study to Evaluate the Educational Counseling Effects in the Choice of Different Combined Hormonal Contraceptives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: hormonal contraceptive methods
combined hormonal contraceptive methods
physician counseling
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 1919
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling
timeFrame: Day of inclusion (Day 0) prior to physician counseling and after physician counseling
Secondary outcomes:
measure: Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method
timeFrame: Up to four months after the counseling visit
Other outcomes:
Locations:
Study officials:
References:
citation: 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.