Recruiting

Observational Study

Sponsor:

Neuroendocrine Associates P.C.

Code:

NCT01097837

Conditions

Epilepsy

Eligibility Criteria

Sex: Female

Age: 18 - 47

Healthy Volunteers: Not accepted

Interventions

Non-interventional

Study Details

Brief 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.

Conditions

Epilepsy

Study ID

NCT01097837

Start date

Mar, 2010

Status verified date

Oct, 2015

Completion date

Dec, 2016

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 47

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women with Epilepsy between 18 and 47

Exclusion Criteria:

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Epilepsy

Cohort is comprised of women with epilepsy between 18 and 47.

Interventions

Non-interventional

This is an observational study conducted by anonymous survey. There is no intervention.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kristen M Fowler, MA

781-431-0277kfowler@bidmc.harvard.edu

Locations

Neuroendocrine Associates P.C.

Recruiting

Wellesley, Massachusetts, United States, 02481

Contacts

Kristen M Fowler, MA

781-431-0277kfowler@bidmc.harvard.edu

Principal Investigator:

Andrew G Herzog, M.D.,M.Sc.

Columbia University Medical Center

Recruiting

New York, New York, United States

Contacts

Kristen M Fowler, MA

781-431-0277kfowler@bidmc.harvard.edu

Principal Investigator:

Anne R Davis, M.D.,M.P.H.

More Information

Sponsor

Neuroendocrine Associates P.C.

Last update posted

Oct 16, 2015

Last verified

Oct, 2015

Keywords

  • Epilepsy
  • Contraceptive
  • Birth Control
  • Seizure
  • This study is looking at the use of different birth control measures in women with epilepsy.

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Neuroendocrine Associates P.C. on 2015-10-16.