We are no longer recruiting volunteers for this particular study.  Please call our office at (860) 443-4567, for information about similar upcoming clinical research studies

 Vaginal Candidiasis

Candidiasis, better known as ‘yeast infection’, is a common fungal infection occurring when there is an overgrowth of the Candida fungus. This overgrowth may be triggered by changes in vaginal acidity or changes in the body’s hormonal balance. The Candida fungus is normally found in small amounts in a woman’s body.

Typically, women with yeast infection experience genital itching, burning, and/or vaginal discharge. These irritations may eventually be accompanied by painful urination and/or painful intercourse.

Today, more women are self-diagnosing themselves with yeast infection due to the availability of over-the-counter treatments. However, misdiagnosis is quite common because of the similar symptoms shared by, for instance, urinary tract infections. We, at Coastal Connecticut Research, are conducting a clinical research trial that may be able to help properly diagnose and treat the condition you are experiencing.


Requirements for Participation

In order to participate in this clinical research study, you must be 18 years of age or older.

You must also have at least one moderate to severe, or two mild signs or symptoms of vaginal candidiasis, namely:

• Feminine itching
• Feminine burning
• Feminine irritation
• Feminine swelling
• Feminine redness
• Pain with urination
• Pain with intercourse

Additional inclusion and exclusion criteria may apply.


Study Medication & Design

This investigational study is designed to compare the safety and efficacy of a single dose of the investigational drug with a single dose of an FDA approved tablet in the treatment of vaginal candidiasis.

This clinical research trial will last for 26 days, and requires three office visits, telephone contacts and the completion of a daily diary.
Qualified participants will receive the study drug and all tests, procedures and visits required by the study at no cost.


Required Testing

All qualified participants will receive study related:

• Physical exams
• Pelvic exams and cultures
• Pregnancy tests
• Pap smears
• Blood lab work
• Vitals (EKGs, heart rate, pulse)

Compensation

Eligible participants will receive up to $130.00 for being in the study. Participants will receive $50.00 for visits 1 and 3, and $30.00 for visit 2. If a participant does not finish the study, they will only be compensated for the portion of the study completed.


Investigators

Robert Spitz, M.D.


Please note:
The preceding is an overview of this clinical trial and is intended to provide prospective patients with information that may help them decide whether to consider participating in the trial. There are additional details regarding study eligibility criteria, and details important to making a final decision regarding participating that are not listed on this page. These will be discussed with interested participants over the phone and in person by a member of Coastal Connecticut Research. All relevant information will be provided in the Informed Consent Form that must be reviewed by the prospective participant.

At Coastal Connecticut Research, we are excited to introduce this research trial to you, and hope that you will consider joining us in this trial.

If you would like more information, or to see if you qualify for this study, please contact study coordinators:

Carolyn Eustace, RA
Karen Cuddy, RN

(860) 443-4567

or contact us by E-mail at CCRvolunteer@gmail.com