Table 3.
Percentage of participants who experienced selected secondary (safety and acceptability) outcomes (Ns based on all-treated (AT) population)
| Outcome ** | C31G (N=836) | Conceptrol (N=560) | p | |
|---|---|---|---|---|
| Infection (%)+ | ||||
| Symptomatic UTI | 3 | 4 | 0.19 | |
| Any UTI | 8 | 8 | 0.55 | |
| BV (based on Amsel’s criteria) | 15 | 15 | 0.78 | |
| Yeast | 10 | 11 | 0.97 | |
| Gonorrhea/Chlamydia | 1 | 1 | ||
| Genitourinary discomfort (%)* | ||||
| Any | 21 | 19 | 0.46 | |
| Irritation | 7 | 6 | ||
| Itching | 8 | 8 | ||
| Burning | 6 | 5 | ||
| Difficulty urinating | 4 | 3 | ||
| Partner discomfort (%)* | 7 | 5 | 0.08 | |
| Acceptability (%) ¥ | ||||
| Liked (strongly/somewhat) | 74 | 75 | 0.51 | |
| Neutral | 15 | 15 | ||
| Disliked (strongly/somewhat) | 11 | 10 | ||
| Would use again (definitely/probably) | 77 | 78 | 0.32 | |
**
Outcomes were those reported at Cycle 6 visit, or exit visit if the subject discontinued early
+
Diagnosis based on urine culture, wet mount, or nucleic acid amplitude test (NAAT), as appropriate.
*
Reported response to the questions, “Since the last visit, did the subject have any genitourinary discomfort?”, and “Since the last visit, did the subject’s partner have any discomfort?”
¥
Based on response to acceptability questionnaire