EpilepsyEBCRNCT01097837
Epilepsy Birth Control Registry
An observational study of Epilepsy, run by Neuroendocrine Associates P.C. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 47 years, women only
- Conditions the study is for
- Epilepsy
- What is being tested?
- Non-interventional
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2010to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 47 years
- Women only
- No healthy volunteers
- Adult
Study population: Participants are women with epilepsy between the ages of 18 and 47.
Who may be able to join
- Women with Epilepsy between 18 and 47
Who cannot join
- Women without epilepsy
- Women under 18
- Women over 47
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Columbia University Medical Center
New York, New York
Kristen M Fowler, MA, 781-431-0277, kfowler@bidmc.harvard.edu
Anne R Davis, M.D.,M.P.H.
- Recruiting
Neuroendocrine Associates P.C.
Wellesley, Massachusetts, 02481
Kristen M Fowler, MA, 781-431-0277, kfowler@bidmc.harvard.edu
Andrew G Herzog, M.D.,M.Sc.
About this study
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
- Being tested
- Non-interventional
- Keywords
- Epilepsy, Contraceptive, Birth Control, Seizure, This study is looking at the use of different birth control measures in women with epilepsy.
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
This is an observational study conducted by anonymous survey. There is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy | Cohort is comprised of women with epilepsy between 18 and 47. Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of seizures on hormonal versus non-hormonal contraception, stratified by antiepileptic drug category
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuroendocrine Associates P.C.
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Principal investigator, Andrew G. Herzog M.D., M.Sc., Neuroendocrine Associates P.C.
- Investigators
- Andrew G Herzog, M.D.,M.Sc., Principal investigator, Neuroendocrine Associates P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097837
- Sponsor's protocol ID
- 137557
- Acronym
- EBCR
- Status last verified
- Oct 2015
- First submitted
- 31 Mar 2010
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epilepsy Birth Control Registry
- ClinicalTrials.gov ID
- NCT01097837
- Acronym / sponsor ID
- EBCR / 137557
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Contraceptive, Birth Control, Seizure, This study is looking at the use of different birth control measures in women with epilepsy.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Neuroendocrine Associates P.C.University, hospital or other
- Collaborators
- Columbia University
- Study start
- Mar 2010
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epilepsy | – | Other: Non-interventionalCohort is comprised of women with epilepsy between 18 and 47. |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants are women with epilepsy between the ages of 18 and 47.
Key inclusion criteria (1 listed)
- Women with Epilepsy between 18 and 47
Key exclusion criteria (3 listed)
- Women without epilepsy
- Women under 18
- Women over 47
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionalThis is an observational study conducted by anonymous survey. There is no intervention. | Other | Epilepsy |
Primary outcome
Number of seizures on hormonal versus non-hormonal contraception, stratified by antiepileptic drug category
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew G Herzog, M.D.,M.Sc. principal investigator
Neuroendocrine Associates P.C.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Neuroendocrine Associates P.C. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristen M Fowler, MA (781-431-0277, kfowler@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of seizures on hormonal versus non-hormonal contraception, stratified by antiepileptic drug category (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2015.