Immune Modulation by Misoprostol

Completed · Early Phase 1

Conditions studied: Gynecological Infection

In brief

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.

Key facts

Study ID

NCT02259309

Run by

Vanderbilt University

People needed

15

Starts

2014-11-01

Expected to finish

2015-11-01

Last updated by the study team

2016-01-14

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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