Immune Modulation by Misoprostol

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02259309

Enrollment

Registered

2014-10-08

Start date

2014-11-30

Completion date

2015-11-30

Last updated

2016-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecological Infection

Keywords

misoprostol, mucosal, cervical, immune, buccal, vaginal

Brief 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.

Interventions

DRUGMisoprostol - buccal

buccal administration

DRUGMisoprostol - vaginal

vaginal administration

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Comparison of misoprostol drug levels in patients after vaginal and buccal administration	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	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	Peripheral blood collected at Days 0, 1, 28, and 29	Peripheral blood collected at Days 0, 1, 28, and 29

Secondary

Measure	Time frame	Description
Sequencing of 16S rRNA gene for microbial ecology studies after vaginal and buccal administration	Vaginal swab at Days 0, 1, 28, and 29	Vaginal swab at Days 0, 1, 28, and 29

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026