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Safety, Tolerability, and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Women

NCT01107106 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 579

Last updated 2013-05-15

No results posted yet for this study

Summary

The purpose of this observational study is to assess the safety and tolerability of ellaOne® in routine conditions of use for emergency contraception in postmenarcheal adolescents and adult women who want to prevent pregnancy up to 5 days after unprotected sexual intercourse.

Conditions

  • Contraception

Interventions

DRUG

ellaOne® (ulipristal acetate)

one single oral dose (30 mg tablet)

DRUG

ellaOne® (ulipristal acetate)

one single oral dose (30 mg tablet)

Sponsors & Collaborators

  • HRA Pharma

    lead INDUSTRY

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-01-31
Completion
2013-02-28

Countries

  • United States
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01107106 on ClinicalTrials.gov