RecruitingNot Applicable

Prospective Data Bank Creation to Study Vaginal Conditions

United States550 participantsStarted 2013-04

Plain-language summary

The purpose of this study is to identify and elucidate the pattern and perhaps role of atypical proteins, cytokines and vaginal microbial flora in the pathogenic mechanisms involved in the development of vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor.

Who can participate

Age range

21 Years – 75 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: * All patients willing to participate, and give informed consent, and * Asymptomatic, non-pregnant, healthy women ages 21 to 75 years with no previous history of any chronic or recurrent vulvovaginal condition who attend our clinical offices for their annual well-woman physical examination. * Non-pregnant women ages 21 to 75 years being evaluated for any gynecological vulvovaginal condition. * Pregnant women ages 21 to 75 years who are both asymptomatic and healthy * Pregnant women ages 21 to 75 who have any gynecological vulvovaginal condition Exclusion Criteria: * Asymptomatic patients ages \< 21 or \> 75, or symptomatic patients ages \< 21 or \> 75 years. * Patients diagnosed with cancer or having any medical condition that is not under control including: diabetes mellitus, hypertension, collagen disease, hemoglobinopathy, renal insufficiency, depression, anxiety, psychosis and panic attacks * Patients unable to follow the protocol or unwilling to participate

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

Cytokines Determination

Timeframe: one time for all except pregnant patients 4 times 12 months

Trial details

NCT IDNCT01829204

SponsorTexas Tech University Health Sciences Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-07

View on ClinicalTrials.gov More Vulvodynia trials