Epilepsy Birth Control Registry

Epilepsy Clinical Trial

— EBCR  

Official title:

Epilepsy Birth Control Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01097837
• Other study ID #: 137557
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2010
• Last updated: October 14, 2015
• Start date: March 2010
• Est. completion date: December 2016

Study information

• Verified date: October 2015
• Source: Neuroendocrine Associates P.C.
• Contact: Kristen M Fowler, MA
• Phone: 781-431-0277
• Email: kfowler[@]bidmc.harvard.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Despite the importance of birth control to women of reproductive age, there has been little formal investigation of the safety and effectiveness of birth control methods in women with epilepsy. To remedy this, doctors from Harvard and Columbia University Medical Schools have developed a website that offers a survey to help us gain more knowledge and some educational material that will be updated regularly to provide the latest information. The ultimate goal is to develop guidelines for the selection of safe and effective birth control methods and to make sure that the best forms of birth control become available to women with epilepsy in all communities of our society.

Go to www.epilepsybirthcontrolregistry.com take our survey and then catch up on the latest information about birth control for women with epilepsy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 47 Years

Eligibility

Inclusion Criteria:

• Women with Epilepsy between 18 and 47

Exclusion Criteria:

• Women without epilepsy

• Women under 18

• Women over 47

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• Non-interventional
This is an observational study conducted by anonymous survey. There is no intervention.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York
United States	Neuroendocrine Associates P.C.	Wellesley	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Neuroendocrine Associates P.C.	Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of seizures on hormonal versus non-hormonal contraception, stratified by antiepileptic drug category		3 years	Yes

External Links

•   Link