NCT01097837

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2010

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 16, 2015

Status Verified

October 1, 2015

Enrollment Period

6.8 years

First QC Date

March 31, 2010

Last Update Submit

October 14, 2015

Conditions

Keywords

EpilepsyContraceptiveBirth ControlSeizureThis study is looking at the use of different birth control measures in women with epilepsy.

Outcome Measures

Primary Outcomes (1)

  • Number of seizures on hormonal versus non-hormonal contraception, stratified by antiepileptic drug category

    3 years

Study Arms (1)

Epilepsy

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

Other: Non-interventional

Interventions

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

Epilepsy

Eligibility Criteria

Age18 Years - 47 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Women with Epilepsy between 18 and 47

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Neuroendocrine Associates P.C.

Wellesley, Massachusetts, 02481, United States

RECRUITING

Columbia University Medical Center

New York, New York, United States

RECRUITING

MeSH Terms

Conditions

EpilepsySeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andrew G Herzog, M.D.,M.Sc.

    Neuroendocrine Associates P.C.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen M Fowler, MA

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 31, 2010

First Posted

April 2, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 16, 2015

Record last verified: 2015-10

Locations