Immune Modulation by Misoprostol

Vanderbilt University

Status and phase: Completed; Early Phase 1

Conditions: Gynecological Infection

Treatments: Drug: Misoprostol - buccal; Drug: Misoprostol - vaginal

Study type: Interventional

Funder types: Other

Identifiers

NCT02259309

140667

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Misoprostol administration - buccal then vaginal

Experimental group

Description:

Vaginal or buccal administration

Treatment:

Drug: Misoprostol - vaginal

Drug: Misoprostol - buccal

Misoprostol administration - vaginal then buccal

Experimental group

Description:

Vaginal or buccal administration

Treatment:

Drug: Misoprostol - vaginal

Drug: Misoprostol - buccal