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Counseling on the Interaction of Hormonal Contraceptives and Antiepileptics

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational handout
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Epilepsy focused on measuring Drug interactions

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • UC San Diego Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Educational handout

Control (no educational handout)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Score on 10 question test
Change in score on knowledge examination (comparison of pretest and posttest score)

Secondary Outcome Measures

Full Information

First Posted
September 26, 2013
Last Updated
June 6, 2019
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT02485756
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Drug interactions

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational handout
Arm Type
Experimental
Arm Description
Participants in the intervention group will read an educational handout on hormonal contraceptives/antiepileptic interactions.
Arm Title
Control (no educational handout)
Arm Type
No Intervention
Arm Description
Those in the standard care group will not receive the educational handout.
Intervention Type
Other
Intervention Name(s)
Educational handout
Intervention Description
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
Primary Outcome Measure Information:
Title
Score on 10 question test
Description
Change in score on knowledge examination (comparison of pretest and posttest score)
Time Frame
Score on pretest (prior to intervention/standard care) and post-test (after intervention/standard care).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila Mody, MD
Organizational Affiliation
UC San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marisa Hildebrand, MPH
Organizational Affiliation
UCSD
Official's Role
Study Director
Facility Information:
Facility Name
UC San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26197260
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.
Results Reference
derived

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Counseling on the Interaction of Hormonal Contraceptives and Antiepileptics

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