Prospective Data Bank Creation to Study Vaginal Conditions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age21-75
SponsorTexas Tech University Health Sciences Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
550 Participants
are grouped into 4 trial groupsGroup A: Non pregnant asymptomatic
Group B: Non pregnant symptomatic
Group C: Pregnant asymptomatic
Group D: Pregnant symptomatic
Trial outcomes
Primary outcomes
1
Cytokines Determination
To determine types of cytokines normally present in women's vagina and in patients with vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor
Time frame
one time for all except pregnant patients 4 times 12 monthsSecondary outcomes
1
Proteins Determination
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).
Time frame
one time for all except pregnant patients 4 times 12 months2
Lactobacillus determination
Long lasting or repetitive insults maintain biochemical changes in the vaginal milieu producing lactobacillus microflora alteration.
Time frame
one time for all except pregnant patients 4 times 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov