Prospective Data Bank Creation to Study Vaginal Conditions (CRIPB-13-002)
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ClinicalTrials.gov Identifier: NCT01829204 |
Recruitment Status :
Recruiting
First Posted : April 11, 2013
Last Update Posted : October 12, 2020
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Condition or disease |
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Vulvodynia Mycoses Bacterial Vaginosis Preterm Labor |

Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 550 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 12 Months |
Official Title: | A Prospective Longitudinal Data Bank Creation to Study Vaginal Conditions With a Novel Diagnostic Approach |
Study Start Date : | April 2013 |
Estimated Primary Completion Date : | July 2027 |
Estimated Study Completion Date : | December 2027 |
Group/Cohort |
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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
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Non pregnant symptomatic
Non-pregnant women ages 12 to 75 years being evaluated for any gynecological vulvovaginal condition.
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Pregnant asymptomatic
Pregnant women ages 12 to 75 years who are both asymptomatic and healthy
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Pregnant symptomatic
Pregnant women ages 12 to 75 who have any gynecological vulvovaginal condition
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- Cytokines Determination [ Time Frame: one 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
- Proteins Determination [ Time Frame: one time for all except pregnant patients 4 times 12 months ]The vaginal milieu will respond to the insult by developing an inflammatory reaction characterized by protein production (in terms of increased protein concentration according to the Bradford protein assay).
- Lactobacillus determination [ Time Frame: one time for all except pregnant patients 4 times 12 months ]Long lasting or repetitive insults maintain biochemical changes in the vaginal milieu producing lactobacillus microflora alteration.

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Ages Eligible for Study: | 21 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
2-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
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829204
United States, Texas | |
TTUHSC Permian Basin | Recruiting |
Midland, Texas, United States, 79701 | |
Contact: Jennifer R Hinojosa, RN 432-335-5113 jennifer.hinojosa@ttuhsc.edu | |
Principal Investigator: Gary Ventolini, MD |
Principal Investigator: | Gary Ventolini, MD | TTUHSC PB |
Publications:
Responsible Party: | Texas Tech University Health Sciences Center |
ClinicalTrials.gov Identifier: | NCT01829204 |
Other Study ID Numbers: |
L13-054 |
First Posted: | April 11, 2013 Key Record Dates |
Last Update Posted: | October 12, 2020 |
Last Verified: | October 2020 |
Mycoses Vaginosis, Bacterial Obstetric Labor, Premature Vulvodynia Vaginal Diseases |
Obstetric Labor Complications Pregnancy Complications Bacterial Infections Vaginitis Vulvar Diseases |