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NCT01771016 Clinical Trial

Emergency Contraception - User's Profile

Postcoital Contraception Clinical Trial

Official title:
Emergency Contraception - Observational Study of User's Profile

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01771016
Other study ID # EKBB 114/07
Secondary ID
Status Completed
Phase N/A
First received January 14, 2013
Last updated January 15, 2013
Start date January 2006
Est. completion date August 2009

Study information
Verified date January 2013
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 729
Est. completion date August 2009
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- women seaking emergency hormonal contraception

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Outcome
Type Measure Description Time frame Safety issue
Other pharmacy status and care activity 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 No
Primary 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?" 2 years Yes
Secondary elapsed hours since unprotected intercourse 1 month Yes