Postcoital ContraceptionNCT01771016
Emergency Contraception - User's Profile
An observational study of Postcoital Contraception, run by University Hospital, Basel, Switzerland.
Trial summary
Retrospective analysis of requests of emergency hormonal contraception using pharmacy protocols registered in 2003 and 2006. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postcoital Contraception
- How many people
- 729 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pharmacies in Basle, Berne or Zurich, three major towns in the German speaking part of Switzerland, were purposively recruited if they had extended opening hours (emergency pharmacies) or if they were located downtown and open during traditional business hours (walk-in pharmacies). The pharmacists were asked if a pharmacy student could come to their place and photocopy the completed official one-page EHC written assessment forms.
Who may be able to join
- women seaking emergency hormonal contraception
Who cannot join
- -
About this study
Official title: Emergency Contraception - Observational Study of User's Profile
Retrospective analysis of requests of emergency hormonal contraception using pharmacy protocols registered in 2003 and 2006.
Read the detailed description
In 2002, Levonorgestrel was introduced in Switzerland for emergency hormonal contraception (EC) without prescription ('pharmacist only'). In 2003, a first analysis of requests of EC showed that the dispensing of EC through pharmacies could successfully be implemented (Lemke et al 2004).
This study was repeated three years later with the aim to explore whether the user's profile has changed after introduction of a low threshold access to EC.
- Conditions
- Postcoital Contraception
- Keywords
- Emergency contraception, Emergency hormonal contraception, Community pharmacies, Pharmaceutical care, Time to access, Written assessments, Switzerland
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual and protective behaviour
questions of interest: "Did you forget to take the pill?", "Did you have any other unprotected sexual intercourse since your last period?" and "Have you ever taken the "morning-after pill" before?"
Measured: 2 years
Secondary outcomes (1)
elapsed hours since unprotected intercourse
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startJan 2006
- Primary completionDec 2008
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postcoital 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 729 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kurt Hersberger, University Hospital, Basel, Switzerland
- Investigators
- Kurt E Hersberger, Prof., Principal investigator, Dept Pharmaceutical Sciences, University Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771016
- Sponsor's protocol ID
- EKBB 114/07
- Status last verified
- Jan 2013
- First submitted
- 14 Jan 2013
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Contraception - Observational Study of User's Profile
- ClinicalTrials.gov ID
- NCT01771016
- Acronym / sponsor ID
- EKBB 114/07
- Conditions
- Postcoital Contraception
- Keywords
- Emergency contraception, Emergency hormonal contraception, Community pharmacies, Pharmaceutical care, Time to access, Written assessments, Switzerland
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 729 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective analysis of requests of emergency hormonal contraception using pharmacy protocols registered in 2003 and 2006.
Detailed description
In 2002, Levonorgestrel was introduced in Switzerland for emergency hormonal contraception (EC) without prescription ('pharmacist only'). In 2003, a first analysis of requests of EC showed that the dispensing of EC through pharmacies could successfully be implemented (Lemke et al 2004).
This study was repeated three years later with the aim to explore whether the user's profile has changed after introduction of a low threshold access to EC.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pharmacies in Basle, Berne or Zurich, three major towns in the German speaking part of Switzerland, were purposively recruited if they had extended opening hours (emergency pharmacies) or if they were located downtown and open during traditional business hours (walk-in pharmacies). The pharmacists were asked if a pharmacy student could come to their place and photocopy the completed official one-page EHC written assessment forms.
Key inclusion criteria (1 listed)
- women seaking emergency hormonal contraception
Key exclusion criteria (1 listed)
- -
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
Sexual and protective behaviour
Time frame: 2 years
questions of interest: "Did you forget to take the pill?", "Did you have any other unprotected sexual intercourse since your last period?" and "Have you ever taken the "morning-after pill" before?"
1 secondary outcome
elapsed hours since unprotected intercourse
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
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.
Kurt E Hersberger, Prof. principal investigator
Dept Pharmaceutical Sciences, University Basel
Questions about this trial
What is this clinical trial studying?
An observational study of Postcoital Contraception, run by University Hospital, Basel, Switzerland.
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 1 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 18 Jan 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sexual and protective behaviour (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2013.