CompletedNot Applicable

Non-Interventional Extension to Investigate Recurrence of Vulvovaginal Candidiasis and Candida Colonization

United States32 participantsStarted 2016-08-16

Plain-language summary

Non-interventional extension study to investigate VVC recurrence and candida colonization following the P2 acute VVC study

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Enrollment in and completed the primary study through the Day 28 visit. * Received at least one dose of study drug in the primary study * Able to give written informed consent prior to completion of the primary study Exclusion Criteria: * Received systemic or topical vaginal non-study antifungal therapy at any time during the primary study * Diagnosed with bacterial vaginosis, trichomonas, gonorrhea, chlamydia, or active herpes at any point during the primary study * The Principal Investigator considers that the subject should not participate in the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to recurrence of clinical signs/symptoms of VVC

Timeframe: Up to Day 90 +/- 14 days

Trial details

NCT IDNCT02888197

SponsorCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-03-15

View on ClinicalTrials.gov More Candidiasis, Vulvovaginal trials