Contraception
Conditions
Keywords
hormonal contraceptive methods, combined hormonal contraceptive methods, physician counseling
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.
Interventions
None listed
Sponsors
Organon and Co
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants who were enrolled in the study | 1,919 |
| Total | 1,919 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 48 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 26.6 years STANDARD_DEVIATION 6.3 |
| Sex: Female, Male Female | 1919 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,871 |
| serious Total, serious adverse events | 0 / 1,871 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Qualified Participants Before Counseling | Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling | Daily Pill | 1207 Participants |
| All Qualified Participants Before Counseling | Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling | Undecided | 336 Participants |
| All Qualified Participants Before Counseling | Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling | Weekly Patch | 60 Participants |
| All Qualified Participants Before Counseling | Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling | Other Method | 171 Participants |
| All Qualified Participants Before Counseling | Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling | Monthy Ring | 97 Participants |
| All Qualified Participants After Counseling | Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling | Other Method | 104 Participants |
| All Qualified Participants After Counseling | Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling | Monthy Ring | 397 Participants |
| All Qualified Participants After Counseling | Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling | Undecided | 40 Participants |
| All Qualified Participants After Counseling | Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling | Daily Pill | 1199 Participants |
| All Qualified Participants After Counseling | Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling | Weekly Patch | 131 Participants |
Comparison: Analysis of the difference in the percentage of participants who chose the Daily Pill before physician counseling and after physician counseling.p-value: 0.70595% CI: [-2.6, 1.8]Chi-squared
Comparison: Analysis of the difference in the percentage of participants who chose the Weekly Patch before physician counseling and after physician counseling.p-value: <0.000195% CI: [2.6, 5]Chi-squared
Comparison: Analysis of the difference in the percentage of participants who chose the Monthly Ring before physician counseling and after physician counseling.p-value: <0.000195% CI: [14.3, 17.8]Chi-squared
Comparison: Analysis of the difference in the percentage of participants who chose Other Method before physician counseling and after physician counseling.p-value: <0.000195% CI: [-5, -2.2]Chi-squared
Comparison: Analysis of the difference in the percentage of participants who chose Undecided before physician counseling and after physician counseling.p-value: <0.000195% CI: [-17.6, -14.1]Chi-squared
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Qualified Participants Before Counseling | Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method | Daily Pill (n=1199) | 5.1 percentage of participants |
| All Qualified Participants Before Counseling | Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method | Other Method (n=104) | 1.9 percentage of participants |
| All Qualified Participants Before Counseling | Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method | Undecided (n=40) | 2.5 percentage of participants |
| All Qualified Participants Before Counseling | Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method | Weekly Patch (n=131) | 6.9 percentage of participants |
| All Qualified Participants Before Counseling | Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method | Monthly Ring (n=397) | 6.0 percentage of participants |