Epilepsy Birth Control Registry (EBCR)

October 14, 2015 updated by: Andrew G. Herzog M.D., M.Sc., Neuroendocrine Associates P.C.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Wellesley, Massachusetts, United States, 02481
        • Recruiting
        • Neuroendocrine Associates P.C.
        • Contact:
        • Principal Investigator:
          • Andrew G Herzog, M.D.,M.Sc.
    • New York
      • New York, New York, United States
        • Recruiting
        • Columbia University Medical Center
        • Contact:
        • Principal Investigator:
          • Anne R Davis, M.D.,M.P.H.
        • Principal Investigator:
          • W Allen Hauser, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 47 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Participants are women with epilepsy between the ages of 18 and 47.

Description

Inclusion Criteria:

  • Women with Epilepsy between 18 and 47

Exclusion Criteria:

  • Women without epilepsy
  • Women under 18
  • Women over 47

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Epilepsy
Cohort is comprised of women with epilepsy between 18 and 47.
Other: Non-interventional
This is an observational study conducted by anonymous survey. There is no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of seizures on hormonal versus non-hormonal contraception, stratified by antiepileptic drug category
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuroendocrine Associates P.C.

Collaborators

Columbia University

Investigators

  • Principal Investigator: Andrew G Herzog, M.D.,M.Sc., Neuroendocrine Associates P.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 31, 2010

First Submitted That Met QC Criteria

April 1, 2010

First Posted (Estimate)

April 2, 2010

Study Record Updates

Last Update Posted (Estimate)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 14, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 137557

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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