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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Choosing Each Hormonal Contraceptive Method Before and After 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. | Day of inclusion (Day 0) prior to physician counseling and after physician counseling |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive 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. | Up to four months after the counseling visit |
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Inclusion Criteria:
Exclusion Criteria:
None
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Healthy women ≥ 18 years of age and < 40 years of age who consult their physician for information on contraception choices
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26329464 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All participants who were enrolled in the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants who were enrolled in the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Choosing Each Hormonal Contraceptive Method Before and After 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. | 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. | Posted | Number | Participants | Day of inclusion (Day 0) prior to physician counseling and after physician counseling |
|
Four months
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 and safety analysis, based on the physician's assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
|
| Secondary | Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive 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. | 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. | Posted | Number | percentage of participants | Up to four months after the counseling visit |
|
|
|
| 0 |
| 1,871 |
| 0 |
| 1,871 |
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.
| Title | Measurements |
|---|---|
|
| Other Method (n=104) |
|
| Undecided (n=40) |
|