Creating a data bank to study vaginal conditions
Official title: A Prospective Longitudinal Data Bank Creation to Study Vaginal Conditions With a Novel Diagnostic Approach
Run by Texas Tech University Health Sciences Center · NCT01829204 · Data updated 2026-11-12
This study is trying to understand how certain proteins and germs in the vagina might be linked to conditions like vulvodynia and recurrent infections by comparing women who have symptoms to those who don’t.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 21 Years to 75 Years |
| Sex | Women only |
| Enrollment | 550 (estimated) |
| Sponsor | Texas Tech University Health Sciences Center Academic / other |
| Locations | 1 site (Midland, Texas) |
| Status | Recruiting |
| Started | April 2013 |
| Main results expected | July 2027 |
| Study ends | December 2027 |
| Registry record updated | December 18, 2025 |
| Trial ID | NCT01829204 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include asymptomatic, non-pregnant women aged 21 to 75 and pregnant women within the same age range, both healthy and those with gynecological conditions.
✕Probably not a fit
Patients under 21 or over 75 years old, as well as those with uncontrolled medical conditions or diagnosed with cancer, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the role of atypical proteins, cytokines, and vaginal microbial flora in conditions such as vulvodynia, recurrent fungal and bacterial vaginosis, and preterm labor. By comparing symptomatic patients with asymptomatic women, the study seeks to identify biochemical changes in the vaginal environment that may contribute to these conditions. A multidisciplinary approach involving microbiology, proteomics, and cytokine evaluation will be employed to gather comprehensive data. The study will include approximately 550 women aged 12 to 75 years.
Why it matters
Potential benefit: If successful, this study could lead to a better understanding of vaginal conditions and improved treatment options for affected patients.
How similar studies have gone: While this study employs a novel approach, similar studies have shown promise in understanding the biochemical mechanisms underlying vaginal conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
TTUHSC Permian Basin
Midland, Texas, United States Recruiting
Study contacts
- Principal investigator: Michael L Galloway, DO — Ttuhsc Pb
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.