Counseling on the Interaction of Hormonal Contraceptives and Antiepileptics

Not Applicable

Completed

• Conditions: Epilepsy
• Interventions: Other: Educational handout

• Registration Number: NCT02485756
• Lead Sponsor: University of California, San Diego

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-09-26
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Study First Submitted QC: 2015-06-29
• Study First Posted: 2015-06-30
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Score on 10 question test	Score on pretest (prior to intervention/standard care) and post-test (after intervention/standard care).	Change in score on knowledge examination (comparison of pretest and posttest score)

Trial Locations

Locations (1)

UC San Diego Medical Center; 🇺🇸 San Diego, California, United States