Completed

NCT Number: NCT02259309

Immune Modulation by Misoprostol

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.

Completed

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Key information

Conditions

Gynecological Infection

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Misoprostol - buccal

Drug

buccal administration

Other names: Cytotec

Misoprostol - vaginal

Drug

vaginal administration

Other names: Cytotec

Primary outcomes

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
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
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
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
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
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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

Gynuity Health Projects

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Oct 8, 2014
Registry last updated: Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.