Counseling on the Interaction of Hormonal Contraceptives and Antiepileptics

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02485756
• Other study ID #: UCSD130139
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: May 2014

Study information

• Verified date: June 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• Educational 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

Locations

Country	Name	City	State
United States	UC San Diego Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on 10 question test	Change in score on knowledge examination (comparison of pretest and posttest score)	Score on pretest (prior to intervention/standard care) and post-test (after intervention/standard care).