An observational study in Contraception, sponsored by Organon and Co. Completed. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-04.
Sponsored by Organon and Co · Observational
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.
Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Healthy women ≥ 18 years of age and \< 40 years of age who consult their physician for information on contraception choices
Exclusion Criteria:
None
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
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.
Time frame: Day of inclusion (Day 0) prior to physician counseling and after physician counseling
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.
Time frame: Up to four months after the counseling visit
| Milestone | All Participants |
|---|---|
| Started | 1919 |
| Completed | 1871 |
| Not completed | 48 |
| Withdrew: Physician decision | 48 |
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.
| Participants | All Qualified Participants Before Counseling | All Qualified Participants After Counseling |
|---|---|---|
| Daily Pill | 1207 | 1199 |
| Weekly Patch | 60 | 131 |
| Monthy Ring | 97 | 397 |
| Other Method | 171 | 104 |
| Undecided | 336 | 40 |
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.
| percentage of participants | All Qualified Participants |
|---|---|
| Daily Pill (n=1199) | 5.1 |
| Weekly Patch (n=131) | 6.9 |
| Monthly Ring (n=397) | 6.0 |
| Other Method (n=104) | 1.9 |
| Undecided (n=40) | 2.5 |
Collected over Four months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Qualified Participants | — | 0/1,871 (0%) | 0/1,871 (0%) |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 26.6 ± 6.3 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 1919 |
| Male | 0 |
No study locations are listed for this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Organon and Co