Recruiting

Observational Study

Sponsor:

Texas Tech University Health Sciences Center

Code:

NCT01829204

Conditions

Vulvodynia

Mycoses

Bacterial Vaginosis

Preterm Labor

Eligibility Criteria

Sex: Female

Age: 21 - 70+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Vulvodynia

Mycoses

Bacterial Vaginosis

Preterm Labor

Study ID

NCT01829204

Start date

Apr, 2013

Status verified date

Dec, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

550 participants

Anticipated

Interventions and Outcome Measures

Arms

Non pregnant asymptomatic

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 symptomatic

Non-pregnant women ages 12 to 75 years being evaluated for any gynecological vulvovaginal condition.

Pregnant asymptomatic

Pregnant women ages 12 to 75 years who are both asymptomatic and healthy

Pregnant symptomatic

Pregnant women ages 12 to 75 who have any gynecological vulvovaginal condition

Primary outcome measure

  • Cytokines Determination [ Time Frame: one time for all except pregnant patients 4 times 12 months ]

Central Contacts and Locations

Locations

TTUHSC Permian Basin

Recruiting

Midland, Texas, United States, 79701

Contacts

Ailena R Mulkey, RN

432-703-5388ailena.mulkey@ttuhsc.edu

Principal Investigator:

Gary Ventolini, MD

More Information

Sponsor

Texas Tech University Health Sciences Center

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Tech University Health Sciences Center on 2025-12-18.