VulvodyniaCRIPB-13-002NCT01829204
Prospective Data Bank Creation to Study Vaginal Conditions
An observational study of Vulvodynia and Mycoses, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvodynia, Mycoses, Bacterial Vaginosis
- How many people
- 550 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study 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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
TTUHSC Permian Basin
Midland, Texas, 79701
Ailena R Mulkey, RN, 432-703-5388, ailena.mulkey@ttuhsc.edu
Gary Ventolini, MD
About this study
Official title: A Prospective Longitudinal Data Bank Creation to Study Vaginal Conditions With a Novel Diagnostic Approach
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.
Read the detailed description
Our approach specifically targets the evaluation of the proteins and cytokines present and the bacteriological analysis of the microflora in the vaginal milieu.
Conjectures:
- An initial insult in the vagina (possibly involving a bacterial, viral or fungal organism or their products) causes modifications in the vaginal milieu
- The vaginal milieu responds to the insult by developing an inflammatory reaction characterized by cytokine and protein production
- Long lasting or repetitive insults maintain biochemical changes in the vaginal milieu producing a reaction, chemical irritation or micro flora alteration by changes in proteins and/or abnormal protein production
- Those changes eventually result in hypersensitivity, irritation, burning, and pain manifested in patients with vulvodynia. And those changes may also result in the recurrence of fungal or bacterial infections
- Those changes may also contribute to initiate the cascade of premature events conducting to cervical effacement and dilation observed in preterm labor
The conjectures will be investigated by using a multidisciplinary approach including: microbiology, proteomics and cytokines evaluation of the vaginal milieu. Specifically we will be comparing an asymptomatic female population to serve as a baseline to patients affected by vulvodynia, recurrent fungal or bacterial vaginosis and/or pregnancy.
This is a prospective, descriptive study of about 550 women age 12 to 75 years. There will be four groups: 1) Asymptomatic healthy women, 2) Women being seen for any gynecological vulvovaginal condition, and 3) Pregnant women who are asymptomatic and healthy, and 4) Pregnant women have any gynecological vulvovaginal condition.
We will evaluate the following:
- Types of cytokines normally present in women and in patients with vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor
- Normal microbiology flora in women and variations present in the vaginal milieu in these patients
- The presence of normal and atypical proteins in the vaginal milieu of healthy women and patients with vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor
- Informed consent will be obtained and documented for participation in the study
- Comprehensive history assessment of environmental factors, topical vulvovaginal issues and co morbid conditions as defined in the exclusion criteria.
- Pelvic examination to obtain two samples via cotton swabs for proteomics, cytokines, vaginal lactobacillus from vaginal secretions.
- Swab procedure:
The cotton swabs (2) will be introduced only in the middle vagina, one at the time, no other areas will be sampled.
- Swab processing One swab will be placed in a special room temperature solution. This de-identified swab will be mailed for Lactobacillus.
The second de-identified swab is to be place in 2 separated micro-containers in Liquid Nitrogen Containers (one for cytokines and one for Proteomics). When 50 samples are completed they will be processed at TTUHSC Permian Basin campus, with the Proteomics testing being done in Lubbock.
Therefore, there are 3 samples, each processed differently. Data will be recorded in a confidential manner with no personal identifiers, only an assigned study subject number. As such, the de-identified data may serve as a database for additional studies. The computer used will belong to TTUHSC and be password protected, access limited to only authorized personnel. Consent forms will be stored separately from the study data in the research office.
- Conditions
- Vulvodynia, Mycoses, Bacterial Vaginosis, Preterm Labor
- Medical subject headings
- Vulvodynia, Mycoses, Vaginosis, Bacterial, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one time for all except pregnant patients 4 times 12 months
Secondary outcomes (2)
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).
Measured: one time for all except pregnant patients 4 times 12 months
Lactobacillus determination
Long lasting or repetitive insults maintain biochemical changes in the vaginal milieu producing lactobacillus microflora alteration.
Measured: one time for all except pregnant patients 4 times 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael L Galloway, DO, Principal investigator, TTUHSC PB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829204
- Sponsor's protocol ID
- L13-054
- Acronym
- CRIPB-13-002
- Status last verified
- Dec 2025
- First submitted
- 8 Apr 2013
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Verstraelen H, Verhelst R, Claeys G, De Backer E, Temmerman M, Vaneechoutte M. Longitudinal analysis of the vaginal microflora in pregnancy suggests that L. crispatus promotes the stability of the normal vaginal microflora and that L. gasseri and/or L. iners are more conducive to the occurrence of abnormal vaginal microflora. BMC Microbiol. 2009 Jun 2;9:116. doi: 10.1186/1471-2180-9-116.
PubMed 19490622Ventolini G, Barhan SM. Vulvodynia. Dermatol Online J. 2008 Jan 15;14(1):2.
PubMed 18319019Ventolini G, Barhan S, Duke J. Vulvodynia, a step-wise therapeutic prospective cohort study. J Obstet Gynaecol. 2009 Oct;29(7):648-50. doi: 10.1080/01443610903095882.
PubMed 19757274Ventolini G. Measuring treatment outcomes in women with vulvodynia. J Clin Med Res. 2011 Apr 4;3(2):59-64. doi: 10.4021/jocmr526w.
PubMed 21811531Ventolini G. Vulvar pain: Anatomic and recent pathophysiologic considerations. Clin Anat. 2013 Jan;26(1):130-3. doi: 10.1002/ca.22160. Epub 2012 Sep 5.
PubMed 22951941Omoigui S. The biochemical origin of pain: the origin of all pain is inflammation and the inflammatory response. Part 2 of 3 - inflammatory profile of pain syndromes. Med Hypotheses. 2007;69(6):1169-78. doi: 10.1016/j.mehy.2007.06.033. Epub 2007 Aug 28.
PubMed 17728071Traisnel G, Lablanche JM, Fourrier JL, Marquand A, Bertrand ME. [Reproducibility of the exercise test and coronary vasomotor tonus]. Arch Mal Coeur Vaiss. 1988 Jun;81(6):765-72. French.
PubMed 3144947
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Longitudinal Data Bank Creation to Study Vaginal Conditions With a Novel Diagnostic Approach
- ClinicalTrials.gov ID
- NCT01829204
- Acronym / sponsor ID
- CRIPB-13-002 / L13-054
- Conditions
- Vulvodynia, Mycoses, Bacterial Vaginosis, Preterm Labor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Our approach specifically targets the evaluation of the proteins and cytokines present and the bacteriological analysis of the microflora in the vaginal milieu.
Conjectures:
- An initial insult in the vagina (possibly involving a bacterial, viral or fungal organism or their products) causes modifications in the vaginal milieu
- The vaginal milieu responds to the insult by developing an inflammatory reaction characterized by cytokine and protein production
- Long lasting or repetitive insults maintain biochemical changes in the vaginal milieu producing a reaction, chemical irritation or micro flora alteration by changes in proteins and/or abnormal protein production
- Those changes eventually result in hypersensitivity, irritation, burning, and pain manifested in patients with vulvodynia. And those changes may also result in the recurrence of fungal or bacterial infections
- Those changes may also contribute to initiate the cascade of premature events conducting to cervical effacement and dilation observed in preterm labor
The conjectures will be investigated by using a multidisciplinary approach including: microbiology, proteomics and cytokines evaluation of the vaginal milieu. Specifically we will be comparing an asymptomatic female population to serve as a baseline to patients affected by vulvodynia, recurrent fungal or bacterial vaginosis and/or pregnancy.
This is a prospective, descriptive study of about 550 women age 12 to 75 years. There will be four groups: 1) Asymptomatic healthy women, 2) Women being seen for any gynecological vulvovaginal condition, and 3) Pregnant women who are asymptomatic and healthy, and 4) Pregnant women have any gynecological vulvovaginal condition.
We will evaluate the following:
- Types of cytokines normally present in women and in patients with vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor
- Normal microbiology flora in women and variations present in the vaginal milieu in these patients
- The presence of normal and atypical proteins in the vaginal milieu of healthy women and patients with vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor
- Informed consent will be obtained and documented for participation in the study
- Comprehensive history assessment of environmental factors, topical vulvovaginal issues and co morbid conditions as defined in the exclusion criteria.
- Pelvic examination to obtain two samples via cotton swabs for proteomics, cytokines, vaginal lactobacillus from vaginal secretions.
- Swab procedure:
The cotton swabs (2) will be introduced only in the middle vagina, one at the time, no other areas will be sampled.
- Swab processing One swab will be placed in a special room temperature solution. This de-identified swab will be mailed for Lactobacillus.
The second de-identified swab is to be place in 2 separated micro-containers in Liquid Nitrogen Containers (one for cytokines and one for Proteomics). When 50 samples are completed they will be processed at TTUHSC Permian Basin campus, with the Proteomics testing being done in Lubbock.
Therefore, there are 3 samples, each processed differently. Data will be recorded in a confidential manner with no personal identifiers, only an assigned study subject number. As such, the de-identified data may serve as a database for additional studies. The computer used will belong to TTUHSC and be password protected, access limited to only authorized personnel. Consent forms will be stored separately from the study data in the research office.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Proteins Determination
Time frame: one time for all except pregnant patients 4 times 12 months
Lactobacillus determination
Time frame: one time for all except pregnant patients 4 times 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Background: PubMed 19490622Verstraelen H, Verhelst R, Claeys G, De Backer E, Temmerman M, Vaneechoutte M. Longitudinal analysis of the vaginal microflora in pregnancy suggests that L. crispatus promotes the stability of the normal vaginal microflora and that L. gasseri and/or L. iners are more conducive to the occurrence of abnormal vaginal microflora. BMC Microbiol. 2009 Jun 2;9:116. doi: 10.1186/1471-2180-9-116.
- Background: PubMed 18319019Ventolini G, Barhan SM. Vulvodynia. Dermatol Online J. 2008 Jan 15;14(1):2.
- Background: PubMed 19757274Ventolini G, Barhan S, Duke J. Vulvodynia, a step-wise therapeutic prospective cohort study. J Obstet Gynaecol. 2009 Oct;29(7):648-50. doi: 10.1080/01443610903095882.
- Background: PubMed 21811531Ventolini G. Measuring treatment outcomes in women with vulvodynia. J Clin Med Res. 2011 Apr 4;3(2):59-64. doi: 10.4021/jocmr526w.
- Background: PubMed 22951941Ventolini G. Vulvar pain: Anatomic and recent pathophysiologic considerations. Clin Anat. 2013 Jan;26(1):130-3. doi: 10.1002/ca.22160. Epub 2012 Sep 5.
- Background: PubMed 17728071Omoigui S. The biochemical origin of pain: the origin of all pain is inflammation and the inflammatory response. Part 2 of 3 - inflammatory profile of pain syndromes. Med Hypotheses. 2007;69(6):1169-78. doi: 10.1016/j.mehy.2007.06.033. Epub 2007 Aug 28.
- Background: PubMed 3144947Traisnel G, Lablanche JM, Fourrier JL, Marquand A, Bertrand ME. [Reproducibility of the exercise test and coronary vasomotor tonus]. Arch Mal Coeur Vaiss. 1988 Jun;81(6):765-72. French.
- Clinical Research Institute TTUHSCLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael L Galloway, DO principal investigator
TTUHSC PB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulvodynia and Mycoses, run by Texas Tech University Health Sciences Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokines Determination (time frame: one time for all except pregnant patients 4 times 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01829204, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.