Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT07109869
Brief Summary:
This is a Phase 3 clinical study to evaluate the efficacy, safety, and tolerability of boric acid 600 mg vaginal inserts in patients with VVC.
Detailed Description:
This clinical study will be a multi-center, randomized, placebo-controlled, double-blinded study with a 3-arm design comparing 600 mg boric acid vaginal inserts dosed for 7 or 14 days to placebo. All patients will self-administer vaginal inserts once daily for 14 days.
During self-administration of the study drug, patients will be instructed to utilize an electronic diary (eDiary) to record their daily symptoms from Screening through Day 28 (Visit 5). The following information will be recorded in the eDiary:
* Study drug administration (including time at which study drug was administered, activity following study drug administration, and whether the bladder was emptied prior to administration);
* Vulvovaginal symptoms;
* Any adverse symptoms or symptoms of concern, illnesses, or physical injuries that occur while participating in the clinical study;
* Contraceptive methods utilized;
* Days of menstrual bleeding, including days of heavy menstrual bleeding (defined as "flooding" or bleeding through ≥1 tampon or sanitary pad in 2 hours or less), start date of menstrual cycle, end date of menstrual cycle, and daily quantity of menstrual hygiene product(s) utilized for each day of menses;
* Position (eg, laying down supine, prone, on side) following study drug administration;
* Vulvovaginal sexual activity, including if the sexual activity occurred before or after study drug administration; and
* The presence of any non-exclusionary intravaginal foreign objects (ie, contraceptive vaginal ring, diaphragm, cervical cap, condom, sex toys).
Patients will complete a total of 4 in-person visits at Screening, on Day 7 (Visit 2) (±2 days), Day 15 (Visit 3) (+2 days), and Day 28 (Visit 5) (±2 days), as well as a telephone Follow-Up Visit on Day 21 (Visit 4) (±2 days) (if clinically indicated, the Follow-Up Visit may be performed in-person).
Clinical, mycological, and overall outcomes will be assessed at Day 15 (Visit 3) and Day 28 (Visit 5) for all study arms. If persistent symptoms are present at any visit, a full microbiologic evaluation to assess for persistence of VVC (including KOH wet mount, saline wet mount, and vaginal fungal culture) will be performed. Additionally, screening tests required to rule out other potential causes of symptoms may be performed or repeated at PI or qualified designee discretion. Patients may also be provided with a rescue treatment at PI or qualified designee discretion.
Individual patient participation is expected to be 28 days.
Study:
NCT07109869
Study Brief:
Protocol Section:
NCT07109869