Clinical trial NCT02485756: Counseling on the Interaction of Hormonal Contraceptives and Antiepileptics
Official title: An Educational Intervention to Increase Knowledge of Drug-drug Interactions Between Antiepileptics and Hormonal Contraception Among Reproductive-aged Women With Epilepsy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: Drug interactions
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Score on 10 question test
timeFrame: Score on pretest (prior to intervention/standard care) and post-test (after intervention/standard care).
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UC San Diego Medical Center
state: California
Study officials:
affiliation: UC San Diego
name: Sheila Mody, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSD
name: Marisa Hildebrand, MPH
role: STUDY_DIRECTOR
References:
citation: Mody SK, Haunschild C, Farala JP, Honerkamp-Smith G, Hur V, Kansal L. An educational intervention on drug interactions and contraceptive options for epilepsy patients: a pilot randomized controlled trial. Contraception. 2016 Jan;93(1):77-80. doi: 10.1016/j.contraception.2015.07.008. Epub 2015 Jul 18.