ContraceptionECOSNCT01181778
Evaluation of Participant Responses to Educational Counseling About Different Combined Hormonal Contraceptive Choices (P06557)
An observational study of Contraception, run by Organon and Co.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- How many people
- 1,919 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Oct 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women ≥ 18 years of age and < 40 years of age who consult their physician for information on contraception choices
Who may be able to join
- 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
Who cannot join
- None
About this study
Official title: Observational, Prospective, Multicenter Study to Evaluate the Educational Counseling Effects in the Choice of Different Combined Hormonal Contraceptives
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.
- Conditions
- Contraception
- Keywords
- hormonal contraceptive methods, combined hormonal contraceptive methods, physician counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of inclusion (Day 0) prior to physician counseling and after physician counseling
Secondary outcomes (1)
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.
Measured: Up to four months after the counseling visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,919 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181778
- Sponsor's protocol ID
- P06557
- Acronym
- ECOS
- Status last verified
- Feb 2022
- First submitted
- 12 Aug 2010
- Last updated
- 4 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26329464
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Prospective, Multicenter Study to Evaluate the Educational Counseling Effects in the Choice of Different Combined Hormonal Contraceptives
- ClinicalTrials.gov ID
- NCT01181778
- Acronym / sponsor ID
- ECOS / P06557
- Conditions
- Contraception
- Keywords
- hormonal contraceptive methods, combined hormonal contraceptive methods, physician counseling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,919 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 13 Aug 2010 (estimated)
- Results
- Posted 24 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women ≥ 18 years of age and < 40 years of age who consult their physician for information on contraception choices
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling
Time frame: 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.
1 secondary outcome
Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method
Time frame: Up to four months after the counseling visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26329464Gambera 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling (time frame: Day of inclusion (Day 0) prior to physician counseling and after physician counseling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01181778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.