Counseling on the Interaction of Hormonal Contraceptives and Antiepileptics

An Educational Intervention to Increase Knowledge of Drug-drug Interactions Between Antiepileptics and Hormonal Contraception Among Reproductive-aged Women With Epilepsy.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02485756

Enrollment

Registered

2015-06-30

Start date

2013-06-30

Completion date

2014-05-31

Last updated

2019-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Drug interactions

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.

Interventions

OTHEREducational 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026