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Trial record 1 of 570 for:    contraception AND (woman OR women OR female) NOT (male OR men)
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Safety, Tolerability, and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01107106
First Posted: April 20, 2010
Last Update Posted: May 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
HRA Pharma
  Purpose
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.

Condition Intervention
Contraception Drug: ellaOne® (ulipristal acetate)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Observational Single Arm Open-Label Multicenter Study to Assess the Safety, Tolerability and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Adult Women

Resource links provided by NLM:


Further study details as provided by HRA Pharma:

Primary Outcome Measures:
  • Frequency of adverse events after ellaOne® intake in routine conditions of use for emergency contraception [ Time Frame: Two months (i.e. all along 2 menstrual cycles following ellaOne® intake) ]
    Collection of adverse events, concomitant treatments, length of menstrual cycle, and vaginal bleeding/spotting through follow-up contacts and a diary completed by the patient


Secondary Outcome Measures:
  • Pregnancy rate observed after taking ellaOne® in routine conditions of use for emergency contraception [ Time Frame: Two months (i.e. during two menstrual cycles following ellaOne® intake) ]

Enrollment: 579
Study Start Date: May 2010
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adolescents
250 postmenarcheal adolescent girls
Drug: ellaOne® (ulipristal acetate)
one single oral dose (30 mg tablet)
Other Name: ellaOne®
Adults
250 adult women
Drug: ellaOne® (ulipristal acetate)
one single oral dose (30 mg tablet)
Other Name: ellaOne®

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adolescents and adult women seeking emergency contraception in family planning centers and youth clinics in Sweden
Criteria

Inclusion Criteria:

  • Having received ellaOne® as emergency contraception at the clinical site
  • Postmenarcheal adolescents or adult women
  • Willing to provide information on bleeding, sexual intercourses, method of contraception, concomitant medications and adverse events for the next two menstrual periods and to complete the diary accordingly
  • Willing to provide information on pregnancy outcome / delivery and newborn's health at delivery
  • Able to provide written informed consent
  • Willing to not participate in a clinical trial before the end of study participation

Exclusion Criteria:

  • Currently participating in any interventional clinical trial (testing an Investigational Medicinal Product)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107106


Locations
United States, Colorado
PPRM Central clinic
Denver, Colorado, United States, CO 80218
PPRM Southwest clinic
Lakewood, Colorado, United States, CO 80232
United States, Pennsylvania
Elizabeth Blackwell Health Center
Philadelphia, Pennsylvania, United States, PA 19107
Locust Health Center
Philadelphia, Pennsylvania, United States, PA19107
Sweden
Dept of Women & Child Health - Karolinska University Hospital
Stockholm, Sweden
United Kingdom
Brook clinic
Belfast, United Kingdom, BT12DX
Sponsors and Collaborators
HRA Pharma
  More Information

Responsible Party: HRA Pharma
ClinicalTrials.gov Identifier: NCT01107106     History of Changes
Other Study ID Numbers: 2914-010
2009-017771-21 ( EudraCT Number )
First Submitted: April 12, 2010
First Posted: April 20, 2010
Last Update Posted: May 15, 2013
Last Verified: May 2013

Keywords provided by HRA Pharma:
Contraceptive Methods
Female Contraception

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes