Epilepsy Birth Control Registry | NCT01097837

Studies
Epilepsy Birth Control Registry

NCT01097837

Sponsor

Neuroendocrine Associates P.C.

Status

Unknown status

Last Update Posted

Oct 16, 2015Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Epilepsy

Interventions

Non-interventional

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Mar 31, 2010

First Submission Date that Met QC Criteria

Apr 1, 2010

First Posted Date

Apr 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2015

Last Update Posted Date

Oct 16, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Neuroendocrine Associates P.C.OTHER

Collaborators

Name	Class
Columbia University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Epilepsy		Cohort is comprised of women with epilepsy between 18 and 47.	Other: Non-interventional

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-interventional	Other	This is an observational study conducted by anonymous survey. There is no intervention.	Epilepsy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with Epilepsy between 18 and 47

Exclusion Criteria:

Women without epilepsy
Women under 18
Women over 47

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

47 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kristen M Fowler, MA	Contact	781-431-0277		kfowler@bidmc.harvard.edu

Overall Officials

Name	Affiliation	Role
Andrew G Herzog, M.D.,M.Sc.	Neuroendocrine Associates P.C.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neuroendocrine Associates P.C.	Recruiting	Wellesley	Massachusetts	02481	United States

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy
D012640	Seizures

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided