Status:
COMPLETED
Immune Modulation by Misoprostol
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
Gynuity Health Projects
Conditions:
Gynecological Infection
Eligibility:
FEMALE
18-45 years
Phase:
EARLY_PHASE1
Brief Summary
The present study is designed to address the null hypothesis that there is no difference in the local and systemic immunomodulatory effects of buccally or vaginally administered misoprostol in healthy...
Eligibility Criteria
Inclusion
- Healthy women 18-45 years of age
- Negative result of urine pregnancy test at screening and prior to each administration of study drug
- Normal, regularly occurring menses (being 25-35 day cycles)
Exclusion
- Use of hormonal contraception (current or past 3 months)
- Use of non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin within two weeks prior to enrollment or planned use of these medications during the study period
- Allergy to prostaglandins
- Previous cervical cancer
- Partial or complete cervical excision
- Previous hysterectomy
- Immunosuppression: either pharmacological or due to comorbidities
- Diabetes mellitus
- Auto-immune disease
- History of lymphoma or leukemia
- Sexually transmitted infection (by self-report) over previous 1 year
- Bacterial Vaginosis or Candidiasis (current or past 3 months)
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02259309
Start Date
November 1 2014
End Date
November 1 2015
Last Update
January 14 2016
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232