Emergency Contraception - User's Profile

January 15, 2013 updated by: Kurt Hersberger, University Hospital, Basel, Switzerland

Emergency Contraception - Observational Study of User's Profile

Retrospective analysis of requests of emergency hormonal contraception using pharmacy protocols registered in 2003 and 2006.

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

729

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • women seaking emergency hormonal contraception

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?"
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
elapsed hours since unprotected intercourse
Time Frame: 1 month
1 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
pharmacy status and care activity
Time Frame: 1 month
pharmacy status (walk-in or emergency), and the three activities of the pharmacists (performance of a pregnancy test, delivery of EHC, referral to a physician).
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kurt E Hersberger, Prof., Dept Pharmaceutical Sciences, University Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

January 14, 2013

First Submitted That Met QC Criteria

January 15, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Estimate)

January 18, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

January 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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