RECRUITING
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Prospective Data Bank Creation to Study Vaginal Conditions
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
🗓️ Study Start (Actual) April 2013
🗓️ Primary Completion (Estimated) July 2027
✅ Study Completion (Estimated) December 2027
👥 Enrollment (Estimated) 550
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Midland, Texas, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 21 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 April 2013
  • First Submitted that Met QC Criteria 10 April 2013
  • First Posted 11 April 2013

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 October 2023
  • Last Update Posted 30 October 2023
  • Last Verified October 2023
I'm interested ...!!