Counseling on the Interaction of Hormonal Contraceptives and Antiepileptics

Completed · Not applicable

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT02485756

Run by

University of California, San Diego

People needed

42

Starts

2013-06-01

Expected to finish

2014-05-01

Last updated by the study team

2019-06-07

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UC San Diego Medical Center — San Diego, California, United States

Full record on ClinicalTrials.gov

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