Over-the-Counter Medication Usage

This study has been completed.
Information provided by:
Florida Hospital
ClinicalTrials.gov Identifier:
First received: February 21, 2007
Last updated: November 20, 2009
Last verified: November 2009

There are several benefits of over-the-counter medications, yet there is little research evaluating how to increase patient compliance when a health care provider suggests an over-the-counter (OTC) medication. We are evaluating two types of physician directions to see which increases patient compliance with OTC medications.

Condition Intervention
Drugs, Non-Prescription
Medication Systems
Behavioral: Verbal advice
Behavioral: Prescription

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Improving Over-the-counter Medication Compliance.

Resource links provided by NLM:

Further study details as provided by Florida Hospital:

Primary Outcome Measures:
  • Determining which of 2 types of physician direction regarding OTC medication usage improves patients compliance, as assessed at 3 and 6 months after enrollment. [ Time Frame: 3 and 6 months after enrollment. ] [ Designated as safety issue: No ]

Enrollment: 246
Study Start Date: February 2007
Study Completion Date: February 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electronic prescription
Patients receive a prescription for specific over-the-counter medications.
Behavioral: Prescription
Patients receive a prescription for a specific over-the-counter medication.
Active Comparator: Verbal advice Behavioral: Verbal advice
Patients receive verbal advice regarding specific over-the-counter medications.

Detailed Description:

Researchers will identify a cohort of gynecologic patients presenting for annual examinations and offer participation in the study. Physician researchers will randomize patients to 2 types of physician directions about OTC medications, then follow compliance over the course of the next 7 months. A total of 123 participants in each arm will undergo recruitment, until a total of 246 participants are recruited.

Inclusion criteria include: female, non-pregnant patients presenting for annual gynecologic examinations between the ages of 19-50.

Exclusion criteria include: outside of study age range, patient taking thyroid medication, history of kidney stones, history of hypercalcemia, non-English speaking.


Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Female patients undergoing annual gynecologic examinations.
  • Ages 19-50.
  • Patients not currently taking certain OTC medications.

Exclusion Criteria:

  • Pregnancy.
  • History of hypercalcemia.
  • History of kidney stones.
  • Outside study age range of 19-50.
  • Patient taking thyroid medication.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439348

United States, Florida
Loch Haven Ob/Gyn Group
Orlando, Florida, United States, 32804
Sponsors and Collaborators
Florida Hospital
Study Chair: D. A Hill, MD Department of Obstetrics and Gynecology, Florida Hospital Family Medicine Residency Program
  More Information

No publications provided

Responsible Party: D. Ashley Hill, M.D., Florida Hospital Department of Obstetrics and Gynecology
ClinicalTrials.gov Identifier: NCT00439348     History of Changes
Other Study ID Numbers: 07.02.01
Study First Received: February 21, 2007
Last Updated: November 20, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Florida Hospital:
Medication compliance
electronic prescription
over-the-counter medications
OTC medications

ClinicalTrials.gov processed this record on April 17, 2014