Prospective Data Bank Creation to Study Vaginal Conditions (CRIPB-13-002)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01829204|
Recruitment Status : Recruiting
First Posted : April 11, 2013
Last Update Posted : December 6, 2017
|Condition or disease|
|Vulvodynia Mycoses Bacterial Vaginosis Preterm Labor|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||550 participants|
|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 :||May 2018|
|Estimated Study Completion Date :||May 2019|
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 women ages 12 to 75 years who are both asymptomatic and healthy
Pregnant women ages 12 to 75 who have any gynecological vulvovaginal condition
- 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.
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 email@example.com|
|Principal Investigator: Gary Ventolini, MD|
|Principal Investigator:||Gary Ventolini, MD||TTUHSC PB|