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Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella (ellipse II)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by HRA Pharma.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
HRA Pharma Identifier:
First received: March 30, 2012
Last updated: September 18, 2014
Last verified: January 2014
The study is aimed at assessing the clinical follow-up and the outcomes of pregnancies exposed to ella, whether due to failure of the emergency contraception or inadvertent exposure during pregnancy.

Condition Intervention
Emergency Contraception
Drug: ella

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

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 ]

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ella Drug: ella
ella, single intake, tablet 30mg


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant women who have been exposed to ella during the menstrual cycle in which the pregnancy started or at any time during pregnancy will be enrolled in the study.
  • Pregnant women, exposed to ella during the menstrual cycle in which the pregnancy started (treatment failure) or at any time during pregnancy (inadvertent exposure during pregnancy)
  • Adolescents and/or adults in the USA, depending on the respective State law
  Contacts and Locations
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Please refer to this study by its identifier: NCT01569737

Contact: Paul Fine, MD +17138316553

United States, New York
Planned Parenthood Federation of America, Inc Recruiting
New York,, New York, United States, 10001
Sponsors and Collaborators
HRA Pharma
Principal Investigator: Paul Fine, MD Planned Parenthood Gulf Coast
  More Information

Responsible Party: HRA Pharma Identifier: NCT01569737     History of Changes
Other Study ID Numbers: 2914-012
Study First Received: March 30, 2012
Last Updated: September 18, 2014

Keywords provided by HRA Pharma:
ulipristal acetate
emergency contraception

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes processed this record on May 22, 2017