Counseling on the Interaction of Hormonal Contraceptives and Antiepileptics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-05-31

Brief Summary

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Previous studies have shown that women on anti-seizure medications are not informed about the pharmaceutical drug interactions between anti-seizure medications (antiepileptic drugs, AEDs) and certain hormonal contraceptive. The goal of this proposed study is to develop and assess the efficacy of an educational handout for participants on the ways AEDs and certain hormonal contraceptives can interact to alter effectiveness of the medications. Reproductive age women (18-45 years old) will be recruited from UCSD Health System Epilepsy clinics. If a patient agrees to participate, she will be given a knowledge exam prior to the clinic appointment to establish baseline understanding of hormonal contraceptive and AED interactions and then the participant will be randomized to receive the intervention (educational handout) or the standard of care (no educational handout). Those in participants in the intervention group will read an educational handout on hormonal contraceptives/AED interactions. Those in the standard care group will not receive this handout and the same knowledge exam will be re-administered to all of the participants after they have completed their appointments to check for knowledge comprehension and short-term knowledge retention. A same-day post-test questionnaire will evaluate participant's intention to discuss hormonal contraceptives/AED interactions with their gynecologist, neurologist or primary care physician.

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Educational handout

Participants in the intervention group will read an educational handout on hormonal contraceptives/antiepileptic interactions.

Group Type EXPERIMENTAL

Educational handout

Intervention Type OTHER

Topics include: interactions between AED and certain hormonal contraceptives, Center for Disease Control and Prevention (CDC) recommendations for alternative contraceptive methods that are not known to interact with AEDs, contraceptive failure rates

Control (no educational handout)

Those in the standard care group will not receive the educational handout.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Educational handout

Topics include: interactions between AED and certain hormonal contraceptives, Center for Disease Control and Prevention (CDC) recommendations for alternative contraceptive methods that are not known to interact with AEDs, contraceptive failure rates

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age of participants: 18-45 years old
* Gender of participants: Female
* Ethnic Background: No limitation, will include minorities
* Health Status: on at least one antiepileptic medication
* Sexually active with men
* English speaking

Exclusion Criteria

* Currently Pregnant
* History of hysterectomy or sterilization procedure
* Removal of both ovaries
* Cannot read or comprehend English language
* Unable to provide informed consent
* Attempting to become pregnant
* Not sexually active with men
* No active telephone number for follow-up contact

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No