Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella / ellaOne

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
HRA Pharma
ClinicalTrials.gov Identifier:
NCT01569737
First received: March 30, 2012
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

The study is aimed at assessing the clinical follow-up and the outcomes of pregnancies exposed to ella/ellaOne, whether due to failure of the emergency contraception or inadvertent exposure during pregnancy.


Condition Intervention
Emergency Contraception
Drug: ellaOne

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Multicenter Observational Study to Assess Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella/ellaOne

Resource links provided by NLM:


Further study details as provided by HRA Pharma:

Primary Outcome Measures:
  • pregnancy outcome [ Time Frame: up to 9 months after pregnancy diagnosis ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: January 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ella/ellaOne Drug: ellaOne
ellaOne, single intake, tablet 30mg

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Pregnant women who have been exposed to ella/ellaOne during the menstrual cycle in which the pregnancy started or at any time during pregnancy will be enrolled in the study.

Criteria
  • Pregnant women, exposed to ella/ellaOne during the menstrual cycle in which the pregnancy started (treatment failure) or at any time during pregnancy (inadvertent exposure during pregnancy)
  • Adolescents and adults in France and Germany; aged from 13 years old in the UK1; Adolescents and/or adults in the USA, depending on the respective State law; adults aged 18 years or more in Spain and Italy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569737

Locations
Spain
Hmnos. López Osaba (Ctro. Salud)
Alicante, Spain, 03005
United Kingdom
Sexual & Reproductive Health Care Partnership
Hull, United Kingdom, HU2 8PX
Sponsors and Collaborators
HRA Pharma
Investigators
Principal Investigator: Israel Nisand, MD Hôpital de Hautepierre, Strasbourg, France
Principal Investigator: Hans-Peter Zahradnik, MD Universtiätsklinikum Freiburg, Freiburg, Germany
Principal Investigator: Rafael Borrego, MD DIATROS, Barcelona, Spain
Principal Investigator: Kate Guthrie, MD Sexual & Reproductive Health Care Partnership, Hull, UK
Principal Investigator: Paul Fine, MD Planned Parenthood Gulf Coast, Houston, USA
  More Information

No publications provided

Responsible Party: HRA Pharma
ClinicalTrials.gov Identifier: NCT01569737     History of Changes
Other Study ID Numbers: 2914-012
Study First Received: March 30, 2012
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration
France: The Commission nationale de l’informatique et des libertés
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Research Ethics Committee
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by HRA Pharma:
ella
ellaOne
ulipristal acetate
pregnancy
emergency contraception

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014