Counseling on the Interaction of Hormonal Contraceptives and Antiepileptics

NCT02485756 | Completed

• 1 other identifier: UCSD130139
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

Drug interactions

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (2)

Educational handout

EXPERIMENTAL

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

Other: Educational handout

Control (no educational handout)

NO INTERVENTION

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

Interventions

Educational handout OTHER

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

Educational handout

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego Medical Center

San Diego, California, 92103, United States

Location

Related Publications (1)

• 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.

  PMID: 26197260 DERIVED

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sheila Mody, MD

  UC San Diego

  PRINCIPAL INVESTIGATOR

• Marisa Hildebrand, MPH

  UCSD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: June 30, 2015
• Study Start: June 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 7, 2019

Record last verified: 2019-06

Locations

US (1)