We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified June 2017 by HRA Pharma
Sponsor:
ClinicalTrials.gov Identifier:
NCT01569737
First Posted: April 3, 2012
Last Update Posted: June 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
HRA Pharma
  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: Observational Model: Other
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: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ella Drug: ella
ella, single intake, tablet 30mg

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: HRA Pharma
ClinicalTrials.gov Identifier: NCT01569737     History of Changes
Other Study ID Numbers: 2914-012
First Submitted: March 30, 2012
First Posted: April 3, 2012
Last Update Posted: June 7, 2017
Last Verified: June 2017

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

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes