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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by HRA Pharma
Sponsor:
Information provided by (Responsible Party):
HRA Pharma
ClinicalTrials.gov Identifier:
NCT01569737
First received: March 30, 2012
Last updated: September 18, 2014
Last verified: January 2014
  Purpose

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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 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 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 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
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

Contacts
Contact: Paul Fine, MD +17138316553 Paul.Fine@ppgulfcoast.org

Locations
United States, New York
Planned Parenthood Federation of America, Inc Recruiting
New York,, New York, United States, 10001
Sponsors and Collaborators
HRA Pharma
Investigators
Principal Investigator: Paul Fine, MD Planned Parenthood Gulf Coast
  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: September 18, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014