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Observational Study on Vaginal Conditions

This study aims to understand the causes of vulvodynia (chronic vaginal pain), recurrent fungal and bacterial vaginosis (vaginal infections), and preterm labor. Researchers are looking at proteins, cytokines (substances that affect immune cells), and vaginal bacteria to see how they might contribute to these conditions. They will compare healthy women to those with these conditions to identify differences. The study is not testing a specific treatment, but rather collecting information to learn more about these health issues. You may be able to join if you are a healthy woman between 21 and 75 years old, not pregnant, and do not have a history of chronic or recurring vaginal conditions.

Study design
This is an observational study with a planned enrollment of 550 women. It is designed to compare asymptomatic women with those affected by specific vaginal conditions.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Cytokines will be measured at one time for most participants, but pregnant patients will have measurements taken 4 times over 12 months.

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NCT01829204

Prospective Data Bank Creation to Study Vaginal Conditions

Recruiting
Not specifiedAges 21–75Observational
Texas Tech University Health Sciences Center
~550 participants
Updated 2025-12-18 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cytokines Determination
Measured over one time for all except pregnant patients 4 times 12 months

Conditions

Vulvodynia
Mycoses
Bacterial Vaginosis
Preterm Labor

Explore related trials

Bacterial VaginosisFungal InfectionPremature LaborVulvodynia

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Michael L Galloway, DO · PRINCIPAL_INVESTIGATOR · TTUHSC PB

Who to contact

Ailena R Mulkey, RN
[email protected]
432-703-5388
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Cytokines Determinationone time for all except pregnant patients 4 times 12 months

    To determine types of cytokines normally present in women's vagina and in patients with vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor