Prospective Data Bank Creation to Study Vaginal Conditions

NCT01829204 | Recruiting DMC

• 1 other identifier: L13-054
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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

  one time for all except pregnant patients 4 times 12 months

Secondary Outcomes (2)

• Proteins Determination

  one time for all except pregnant patients 4 times 12 months

• Lactobacillus determination

  one time for all except pregnant patients 4 times 12 months

Study Arms (4)

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

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

TTUHSC Permian Basin

Midland, Texas, 79701, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 19490622 BACKGROUND

• Ventolini G, Barhan SM. Vulvodynia. Dermatol Online J. 2008 Jan 15;14(1):2.

  PMID: 18319019 BACKGROUND

• Ventolini 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.

  PMID: 19757274 BACKGROUND

• Ventolini G. Measuring treatment outcomes in women with vulvodynia. J Clin Med Res. 2011 Apr 4;3(2):59-64. doi: 10.4021/jocmr526w.

  PMID: 21811531 BACKGROUND

• Ventolini 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.

  PMID: 22951941 BACKGROUND

• Omoigui 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.

  PMID: 17728071 BACKGROUND

• Traisnel 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.

  PMID: 3144947 BACKGROUND

Related Links

• Clinical Research Institute TTUHSC

MeSH Terms

Conditions

Vulvodynia; Mycoses; Vaginosis, Bacterial; Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Bacterial Infections and Mycoses; Infections; Bacterial Infections; Vaginitis; Vaginal Diseases; Obstetric Labor Complications; Pregnancy Complications

Study Officials

• Michael L Galloway, DO

  TTUHSC PB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 11, 2013
• Study Start: April 1, 2013
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)