Counseling on the Interaction of Hormonal Contraceptives and Antiepileptics

University of California San Diego

Status: Completed

Conditions: Epilepsy

Treatments: Other: Educational handout

Study type: Interventional

Funder types: Other

Identifiers

NCT02485756

UCSD130139

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Educational handout

Experimental group

Description:

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

Treatment:

Other: Educational handout

Control (no educational handout)

No Intervention group

Description:

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