Over-the-Counter Medication Usage
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ClinicalTrials.gov Identifier: NCT00439348 |
Recruitment Status
:
Completed
First Posted
: February 23, 2007
Last Update Posted
: November 23, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Drugs, Non-Prescription Medication Systems | Behavioral: Verbal advice Behavioral: Prescription | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 246 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Improving Over-the-counter Medication Compliance. |
Study Start Date : | February 2007 |
Actual Primary Completion Date : | November 2008 |
Actual Study Completion Date : | February 2009 |

Arm | Intervention/treatment |
---|---|
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.
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Active Comparator: Verbal advice |
Behavioral: Verbal advice
Patients receive verbal advice regarding specific over-the-counter medications.
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- 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. ]

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Ages Eligible for Study: | 19 Years to 50 Years (Adult) |
Sexes 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439348
United States, Florida | |
Loch Haven Ob/Gyn Group | |
Orlando, Florida, United States, 32804 |
Study Chair: | D. A Hill, MD | Department of Obstetrics and Gynecology, Florida Hospital Family Medicine Residency Program |
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 |
First Posted: | February 23, 2007 Key Record Dates |
Last Update Posted: | November 23, 2009 |
Last Verified: | November 2009 |
Keywords provided by Florida Hospital:
Calcium Compliance Medication compliance |
electronic prescription over-the-counter medications OTC medications |