Immune Modulation by Misoprostol

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University
• Collaborator: Gynuity Health Projects
• Treatments: Misoprostol

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)