Emergency Contraception - User's Profile | NCT01771016

Studies
Emergency Contraception - User's Profile

NCT01771016

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Jan 18, 2013Estimated

Enrollment

729Actual

Phase

Not provided

Conditions

Postcoital Contraception

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Dec 2008Actual

Completion Date

Aug 2009Actual

First Submitted Date

Jan 14, 2013

First Submission Date that Met QC Criteria

Jan 15, 2013

First Posted Date

Jan 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2013

Last Update Posted Date

Jan 18, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kurt Hersberger, Prof., University Hospital, Basel, SwitzerlandPrincipal Investigator

Lead Sponsor

University Hospital, Basel, SwitzerlandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

729Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
elapsed hours since unprotected intercourse		1 month

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women seaking emergency hormonal contraception

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kurt E Hersberger, Prof.	Dept Pharmaceutical Sciences, University Basel	Principal Investigator

Locations

Not provided