Immune Modulation by Misoprostol

Study Overview
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Brief Summary
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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.

Official Title
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Immune Modulation by Misoprostol

Conditions
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Gynecological Infection

Intervention / Treatment
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* Drug: Misoprostol - buccal
* Drug: Misoprostol - vaginal


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Misoprostol administration - buccal then vaginal<br>Vaginal or buccal administration | Drug: Misoprostol - buccal<br>* buccal administration<br>* Other names: Cytotec;Drug: Misoprostol - vaginal<br>* vaginal administration<br>* Other names: Cytotec;|
| Experimental: Misoprostol administration - vaginal then buccal<br>Vaginal or buccal administration | Drug: Misoprostol - buccal<br>* buccal administration<br>* Other names: Cytotec;Drug: Misoprostol - vaginal<br>* vaginal administration<br>* Other names: Cytotec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of misoprostol drug levels in patients after vaginal and buccal administration | Peripheral blood collected at Days 0, 1, 28, and 29 | Peripheral blood collected at Days 0, 1, 28, and 29 | 
| Comparison of cytokine and chemokine levels in patients after vaginal and buccal administration | Peripheral blood collected at Days 0, 1, 28, and 29 | Peripheral blood collected at Days 0, 1, 28, and 29 | 
| Determination of immune cell activation state after vaginal and buccal administration | Peripheral blood collected at Days 0, 1, 28, and 29 | Peripheral blood collected 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mucosal, misoprostol, cervical, immune, buccal, vaginal