Over-the-Counter Medication Usage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00439348
Recruitment Status : Completed
First Posted : February 23, 2007
Last Update Posted : November 23, 2009
Information provided by:
Florida Hospital

February 21, 2007
February 23, 2007
November 23, 2009
February 2007
November 2008   (Final data collection date for primary outcome measure)
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. ]
Whether an electronic written prescription increases calcium compliance compared to verbal information only, as assessed at 3 and 6 months after enrollment .
Complete list of historical versions of study NCT00439348 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Over-the-Counter Medication Usage
Improving Over-the-counter Medication Compliance.
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Drugs, Non-Prescription
  • Medication Systems
  • Behavioral: Verbal advice
    Patients receive verbal advice regarding specific over-the-counter medications.
  • Behavioral: Prescription
    Patients receive a prescription for a specific over-the-counter medication.
  • Experimental: Electronic prescription
    Patients receive a prescription for specific over-the-counter medications.
    Intervention: Behavioral: Prescription
  • Active Comparator: Verbal advice
    Intervention: Behavioral: Verbal advice
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
February 2009
November 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
19 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
D. Ashley Hill, M.D., Florida Hospital Department of Obstetrics and Gynecology
Florida Hospital
Not Provided
Study Chair: D. A Hill, MD Department of Obstetrics and Gynecology, Florida Hospital Family Medicine Residency Program
Florida Hospital
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP