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
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, see Learn About Clinical Studies.

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 July 26, 2014