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

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ClinicalTrials.gov Identifier: NCT01569737
Recruitment Status : Recruiting
First Posted : April 3, 2012
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
HRA Pharma

Brief Summary:
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 or disease Intervention/treatment
Emergency Contraception Drug: ella

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Multicenter Observational Study to Assess Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella
Study Start Date : January 2012
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Group/Cohort Intervention/treatment
ella Drug: ella
ella, single intake, tablet 30mg



Primary Outcome Measures :
  1. pregnancy outcome [ Time Frame: up to 9 months after pregnancy diagnosis ]


Information from the National Library of Medicine

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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.
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

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): 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

Responsible Party: HRA Pharma
ClinicalTrials.gov Identifier: NCT01569737     History of Changes
Other Study ID Numbers: 2914-012
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018

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

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes