Emergency Contraception - User's Profile

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kurt Hersberger, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01771016
First received: January 14, 2013
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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


Condition
Postcoital Contraception

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Emergency Contraception - Observational Study of User's Profile

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Sexual and protective behaviour [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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?"


Secondary Outcome Measures:
  • elapsed hours since unprotected intercourse [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • pharmacy status and care activity [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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).


Enrollment: 729
Study Start Date: January 2006
Study Completion Date: August 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • women seaking emergency hormonal contraception

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771016

Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Kurt E Hersberger, Prof. Dept Pharmaceutical Sciences, University Basel
  More Information

No publications provided

Responsible Party: Kurt Hersberger, Prof., University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01771016     History of Changes
Other Study ID Numbers: EKBB 114/07
Study First Received: January 14, 2013
Last Updated: January 15, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
Emergency contraception
Emergency hormonal contraception
Community pharmacies
Pharmaceutical care
Time to access
Written assessments
Switzerland

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 14, 2014