Clinical trial NCT02259309: Immune Modulation by Misoprostol
Official title: Immune Modulation by Misoprostol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Gynecological Infection
Keywords: misoprostol
mucosal
cervical
immune
buccal
vaginal
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Gynuity Health Projects
First posted: 2014-10-08
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Comparison of misoprostol drug levels in patients after vaginal and buccal administration
timeFrame: Peripheral blood collected at Days 0, 1, 28, and 29
measure: Comparison of cytokine and chemokine levels in patients after vaginal and buccal administration
timeFrame: Peripheral blood collected at Days 0, 1, 28, and 29
measure: Determination of immune cell activation state after vaginal and buccal administration
timeFrame: Peripheral blood collected at Days 0, 1, 28, and 29
measure: Comparison of misoprostol drug levels in patients after vaginal and buccal administration
timeFrame: Cervicovaginal lavage at Days 0, 1, 28, and 29
measure: Comparison of cytokine and chemokine levels in patients after vaginal and buccal administration
timeFrame: Cervicovaginal lavage at Days 0, 1, 28, and 29
measure: Determination of immune cell activation state after vaginal and buccal administration
timeFrame: Cervical cytobrush at Days 0, 1, 28, and 29
Secondary outcomes:
measure: Sequencing of 16S rRNA gene for microbial ecology studies after vaginal and buccal administration
timeFrame: Vaginal swab at Days 0, 1, 28, and 29
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: David M. Aronoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
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