Seizure DisorderNCT00179426
Effect of Antiseizure Medication on Hormone Levels and Sexual Function in Men With Epilepsy
An observational study of Seizure Disorder and Epilepsy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if antiseizure drugs affect hormone levels and sexual function in men with seizures. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Seizure Disorder, Epilepsy
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to Jun 2006
- 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 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Must be a male between 18-50 years of age
- Must have seizures
- Must be on antiseizure medication for at least six months duration
Who cannot join
- Must not have taken hormones, major tranquilizers or antidepressants for at least 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Antiseizure Medication-Induced Elevation of Serum Estradiol and Reproductive Dysfunction in Men With Epilepsy
The purpose of this study is to determine if antiseizure drugs affect hormone levels and sexual function in men with seizures.
Read the detailed description
This study involves donating two small tubes of blood for hormonal testing, which will be drawn at the same time as your routine blood draw for the monitoring of your antiseizure medication. You will also be asked to fill out a short confidential questionnaire regarding your sexual interest and function.
- Conditions
- Seizure Disorder, Epilepsy
- Keywords
- Seizure Disorder, Hypogonadism, Sexual Function, Epilepsy
- Medical subject headings
- Epilepsy, Hypogonadism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 1999
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seizure DisorderStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- Time perspective
- Other
- Enrolment
- 175 participants
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Andrew Herzog, Beth Israel Deaconess Medical Center
- Investigators
- Andrew G. Herzog, M.D., M.Sc., Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179426
- Sponsor's protocol ID
- 2001P000596
- Status last verified
- Mar 2017
- First submitted
- 12 Sep 2005
- Last updated
- 13 Mar 2017
- Results posted
- No
Publications
Herzog AG, Drislane FW, Schomer DL, Pennell PB, Bromfield EB, Kelly KM, Farina EL, Frye CA. Differential effects of antiepileptic drugs on sexual function and reproductive hormones in men with epilepsy: interim analysis of a comparison between lamotrigine and enzyme-inducing antiepileptic drugs. Epilepsia. 2004 Jul;45(7):764-8. doi: 10.1111/j.0013-9580.2004.60703.x.
PubMed 15230699
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiseizure Medication-Induced Elevation of Serum Estradiol and Reproductive Dysfunction in Men With Epilepsy
- ClinicalTrials.gov ID
- NCT00179426
- Acronym / sponsor ID
- 2001P000596
- Conditions
- Seizure Disorder, Epilepsy
- Keywords
- Seizure Disorder, Hypogonadism, Sexual Function, Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Oct 1999
- Study completion
- Jun 2006
- First posted
- 16 Sep 2005 (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.
The purpose of this study is to determine if antiseizure drugs affect hormone levels and sexual function in men with seizures.
Detailed description
This study involves donating two small tubes of blood for hormonal testing, which will be drawn at the same time as your routine blood draw for the monitoring of your antiseizure medication. You will also be asked to fill out a short confidential questionnaire regarding your sexual interest and function.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must be a male between 18-50 years of age
- Must have seizures
- Must be on antiseizure medication for at least six months duration
Key exclusion criteria (1 listed)
- Must not have taken hormones, major tranquilizers or antidepressants for at least 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Results publication: PubMed 15230699Herzog AG, Drislane FW, Schomer DL, Pennell PB, Bromfield EB, Kelly KM, Farina EL, Frye CA. Differential effects of antiepileptic drugs on sexual function and reproductive hormones in men with epilepsy: interim analysis of a comparison between lamotrigine and enzyme-inducing antiepileptic drugs. Epilepsia. 2004 Jul;45(7):764-8. doi: 10.1111/j.0013-9580.2004.60703.x.
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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
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seizure Disorder and Epilepsy, run by Beth Israel Deaconess Medical Center at 1 site 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00179426, which also lists 1 linked publication.
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 13 Mar 2017.