Trial Outcomes & Findings for Evaluation of Participant Responses to Educational Counseling About Different Combined Hormonal Contraceptive Choices (P06557) (NCT NCT01181778)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

1919 participants

Primary outcome timeframe

Day of inclusion (Day 0) prior to physician counseling and after physician counseling

Results posted on

2022-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants All participants who were enrolled in the study
Overall Study STARTED	1919
Overall Study COMPLETED	1871
Overall Study NOT COMPLETED	48

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants All participants who were enrolled in the study
Overall Study Physician Decision	48

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=1919 Participants All participants who were enrolled in the study
Age, Continuous	26.6 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	1919 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day of inclusion (Day 0) prior to physician counseling and after physician counseling

Population: The analysis population consisted of all participants who completed questionnaires before and after physician counseling and had no medical reason to prevent them from using a combined hormonal contraception method.

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.

Outcome measures

Outcome measures
Measure	All Qualified Participants Before Counseling n=1871 Participants Before counseling: All healthy women who were eligible for primary and secondary outcome measure analysis, based on the physician's assessment	All Qualified Participants After Counseling n=1871 Participants After counseling: All healthy women who were eligible for primary and secondary outcome measure analysis, based on the physician's assessment
Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling Weekly Patch	60 Participants	131 Participants
Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling Daily Pill	1207 Participants	1199 Participants
Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling Monthy Ring	97 Participants	397 Participants
Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling Other Method	171 Participants	104 Participants
Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling Undecided	336 Participants	40 Participants

SECONDARY outcome

Timeframe: Up to four months after the counseling visit

Population: The analysis population consisted of all participants who completed questionnaires before and after physician counseling and had no medical reason to prevent them from using a combined hormonal contraception 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.

Outcome measures

Outcome measures
Measure	All Qualified Participants Before Counseling n=1871 Participants Before counseling: All healthy women who were eligible for primary and secondary outcome measure analysis, based on the physician's assessment	All Qualified Participants After Counseling After counseling: All healthy women who were eligible for primary and secondary outcome measure analysis, based on the physician's assessment
Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method Daily Pill (n=1199)	5.1 percentage of participants	—
Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method Weekly Patch (n=131)	6.9 percentage of participants	—
Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method Monthly Ring (n=397)	6.0 percentage of participants	—
Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method Other Method (n=104)	1.9 percentage of participants	—
Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method Undecided (n=40)	2.5 percentage of participants	—

Adverse Events

All Qualified Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigators have accepted and committed not to disclose information herein contained. Investigators will not to publish or disclose any results pertaining to the study without written authorization by the Sponsor. Investigators accept that the Sponsor will review any manuscript or abstract 30 days before submission for a publication or presentation (including oral presentations) containing data derived from the present study.
Publication restrictions are in place

Restriction type: OTHER