Immune Modulation by Misoprostol

January 12, 2016 updated by: David Aronoff, Vanderbilt University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Misoprostol administration - buccal then vaginal
Vaginal or buccal administration
Drug: Misoprostol - buccal
buccal administration
Other Names:
  • Cytotec
Drug: Misoprostol - vaginal
vaginal administration
Other Names:
  • Cytotec
Experimental: Misoprostol administration - vaginal then buccal
Vaginal or buccal administration
Drug: Misoprostol - buccal
buccal administration
Other Names:
  • Cytotec
Drug: Misoprostol - vaginal
vaginal administration
Other Names:
  • Cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of misoprostol drug levels in patients after vaginal and buccal administration
Time Frame: Peripheral blood collected at Days 0, 1, 28, and 29
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
Time Frame: Peripheral blood collected at Days 0, 1, 28, and 29
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
Time Frame: Peripheral blood collected at Days 0, 1, 28, and 29
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
Time Frame: Cervicovaginal lavage at Days 0, 1, 28, and 29
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
Time Frame: Cervicovaginal lavage at Days 0, 1, 28, and 29
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
Time Frame: Cervical cytobrush at Days 0, 1, 28, and 29
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
Time Frame: Vaginal swab at Days 0, 1, 28, and 29
Vaginal swab at Days 0, 1, 28, and 29
Vaginal swab at Days 0, 1, 28, and 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

Gynuity Health Projects

Investigators

  • Principal Investigator: David M. Aronoff, MD, Vanderbilt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

September 22, 2014

First Submitted That Met QC Criteria

October 3, 2014

First Posted (Estimate)

October 8, 2014

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 140667

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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