Immune Modulation by Misoprostol
Early Phase 1
Completed
- Conditions
- Gynecological Infection
- Interventions
- Registration Number
- NCT02259309
- Lead Sponsor
- Vanderbilt University
- 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, reproductive-age women.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 15
Inclusion Criteria
- 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 Criteria
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Misoprostol administration - vaginal then buccal Misoprostol - vaginal Vaginal or buccal administration Misoprostol administration - vaginal then buccal Misoprostol - buccal Vaginal or buccal administration Misoprostol administration - buccal then vaginal Misoprostol - buccal Vaginal or buccal administration Misoprostol administration - buccal then vaginal Misoprostol - vaginal Vaginal or buccal administration
- Primary Outcome Measures
Name Time Method Determination of immune cell activation state after vaginal and buccal administration Cervical cytobrush at Days 0, 1, 28, and 29 Cervical cytobrush at Days 0, 1, 28, and 29
Comparison of misoprostol drug levels in patients after vaginal and buccal administration Cervicovaginal lavage at Days 0, 1, 28, and 29 Cervicovaginal lavage at Days 0, 1, 28, and 29
Comparison of cytokine and chemokine levels in patients after vaginal and buccal administration Cervicovaginal lavage at Days 0, 1, 28, and 29 Cervicovaginal lavage at Days 0, 1, 28, and 29
- Secondary Outcome Measures
Name Time Method Sequencing of 16S rRNA gene for microbial ecology studies after vaginal and buccal administration Vaginal swab at Days 0, 1, 28, and 29 Vaginal swab at Days 0, 1, 28, and 29
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular pathways does misoprostol modulate in vaginal vs. buccal administration for gynecological immune responses?
How does misoprostol's immunomodulatory effect compare to standard-of-care treatments for gynecological infections in clinical trials?
Which biomarkers correlate with systemic or local immune response variability in NCT02259309 misoprostol administration studies?
What adverse events are associated with buccal or vaginal misoprostol in reproductive-age women, and how are they managed?
Are there synergistic immune modulation strategies combining misoprostol with other PGE1 analogs or immunotherapies for gynecological conditions?
Trial Locations
- Locations (1)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center🇺🇸Nashville, Tennessee, United States