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

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01181778
• Collaborator: (none)
• Enrollment: 1,919
• Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception

Study Design

• Study Type: Observational
• Actual Enrollment: 1919 participants
• 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
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling [Day of inclusion (Day 0) prior to physician counseling and after physician 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.

Secondary Outcome Measures

1. Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method [Up to four months after the counseling visit]

   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.

Eligibility Criteria

Criteria

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

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

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT01181778
• Other Study ID Numbers: P06557
• First Posted: Aug 13, 2010
• Last Update Posted: Feb 4, 2022
• Last Verified: Feb 1, 2022

• Keywords provided by Organon and Co: hormonal contraceptive methods; combined hormonal contraceptive methods; physician counseling

Study Results

Participant Flow

Arm/Group Title	All Participants
Arm/Group Description	All participants who were enrolled in the study
Period Title: Overall Study
STARTED	1919
COMPLETED	1871
NOT COMPLETED	48

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	All participants who were enrolled in the study
Overall Participants	1919
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.6 (6.3)
Sex: Female, Male (Count of Participants)
Female	1919 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling
Description	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.
Time Frame	Day of inclusion (Day 0) prior to physician counseling and after physician counseling

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	All Qualified Participants Before Counseling	All Qualified Participants After Counseling
Arm/Group Description	Before counseling: All healthy women who were eligible for primary and secondary outcome measure analysis, based on the physician's assessment	After counseling: All healthy women who were eligible for primary and secondary outcome measure analysis, based on the physician's assessment
Measure Participants	1871	1871
Daily Pill	1207 62.9%	1199 NaN
Weekly Patch	60 3.1%	131 NaN
Monthy Ring	97 5.1%	397 NaN
Other Method	171 8.9%	104 NaN
Undecided	336 17.5%	40 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Qualified Participants Before Counseling, All Qualified Participants After Counseling
	Comments	Analysis of the difference in the percentage of participants who chose the Daily Pill before physician counseling and after physician counseling.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.705
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage: Daily Pill
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 95%; -2.6 to 1.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	All Qualified Participants Before Counseling, All Qualified Participants After Counseling
	Comments	Analysis of the difference in the percentage of participants who chose the Weekly Patch before physician counseling and after physician counseling.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage: Weekly Patch
	Estimated Value	3.8
	Confidence Interval	(2-Sided) 95%; 2.6 to 5.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	All Qualified Participants Before Counseling, All Qualified Participants After Counseling
	Comments	Analysis of the difference in the percentage of participants who chose the Monthly Ring before physician counseling and after physician counseling.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage: Monthy Ring
	Estimated Value	16.0
	Confidence Interval	(2-Sided) 95%; 14.3 to 17.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	All Qualified Participants Before Counseling, All Qualified Participants After Counseling
	Comments	Analysis of the difference in the percentage of participants who chose Other Method before physician counseling and after physician counseling.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage: Other Method
	Estimated Value	-3.6
	Confidence Interval	(2-Sided) 95%; -5.0 to -2.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	All Qualified Participants Before Counseling, All Qualified Participants After Counseling
	Comments	Analysis of the difference in the percentage of participants who chose Undecided before physician counseling and after physician counseling.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage: Undecided
	Estimated Value	-15.8
	Confidence Interval	(2-Sided) 95%; -17.6 to -14.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method
Description	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.
Time Frame	Up to four months after the counseling visit

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	All Qualified Participants
Arm/Group Description	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
Measure Participants	1871
Daily Pill (n=1199)	5.1 0.3%
Weekly Patch (n=131)	6.9 0.4%
Monthly Ring (n=397)	6.0 0.3%
Other Method (n=104)	1.9 0.1%
Undecided (n=40)	2.5 0.1%

Adverse Events

Time Frame	Four months
Adverse Event Reporting Description	Of the 1919 participants enrolled in the study, 48 participants did not meet eligibility requirements for primary and secondary outcome measure analysis and safety analysis, based on physicians' assessments.
Arm/Group Title	All Qualified Participants
Arm/Group Description	All healthy women who consulted their physician for information on contraceptive choices and were eligible for primary and secondary outcome measure analysis and safety analysis, based on the physician's assessment
All Cause Mortality
	All Qualified Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Qualified Participants
	Affected / at Risk (%)	# Events
Total	0/1871 (0%)
Other (Not Including Serious) Adverse Events
	All Qualified Participants
	Affected / at Risk (%)	# Events
Total	0/1871 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.