Multi-Center Study of New Medications to Treat Vaginal Infections

Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection

Signs (edema, erythema, excoriation) and symptoms (itching, burning irritation) were each scored as absent (0), mild (1), moderate (2) or severe (3). A total sign score of 0-9 and total symptom score of 0-9 were combined for a total possible combined sign and symptom score of 0-18. Total median combined sign and symptom severity score was compared between arms at the test of cure visit. Lower scores at day 7-14 indicate improvement.

Time frame: 7-14 days after beginning treatment

Mycologic Cure

Vaginal swabs were cultured for Candida species in a laboratory. A positive culture indicates presence of vaginal yeast and a negative culture indicates absence of vaginal yeast. A negative culture indicates mycologic cure.

Time frame: 7-14 days after beginning treatment and at 21-30 days after beginning treatment

Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit

Subjects reported if symptoms completely resolved and the date of resolution. The percentage of participants reporting complete resolution of symptoms was compared between arms.

Time frame: 7-14 days after beginning treatment

Number of Participants With Treatment Emergent Adverse Events

Adverse events were collected at study visits, from subject diaries and from spontaneous reports

Time frame: Any time during study participation (up to 30 days)