Use Misoprostol to Optimize Prevention of Cervical Cancer (MISOPCx)

August 26, 2026 updated by: Warner Huh, University of Alabama at Birmingham

Misoprostol to Optimizing Prevention of Cancer of the Cervix: A Double-Blind Randomized Controlled Trial

This is a double-blind randomized controlled trial of 420 non-pregnant women undergoing cancer screening by visual inspection with acetic acid (VIA) who have Type 3 transformation zone (TZ) and randomized to receive either Misoprostol or placebo.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

420

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

  • Name: Warner K Huh, MD
  • Phone Number: 2059341555
  • Email: whuh@uabmc.edu

Study Contact Backup

  • Name: Simon M Manga, PhD
  • Phone Number: 2059345612
  • Email: smanga@uab.edu

Study Locations

  • Cameroon
    • Center Region
      • Yaoundé, Center Region, Cameroon, 2034
        • Recruiting
        • Cameroon Baptist Convention Health Core, EtougEbe Baptist Hospital Yaoundé
        • Principal Investigator:
          • Warner K Huh, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Simon M Manga, PhD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Diagnosis of Type 3 TZ confirmed on exam prior to randomization
  • Age 25 years or older

Exclusion Criteria:

  • With Type 1 or 2 TZ prior to randomization
  • Currently pregnant
  • History of hysterectomy
  • Any cancerous lesions
  • Active cervicitis

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: Screening
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-pregnant women
Non-pregnant women will either receive 600 mcg misoprostol (3 tablets) or identical placebo 3 (tablets) administered vaginally 2-3 hours and 4-6 hours prior to visual inspection with acetic acid (VIA).
Drug: Placebo
Participants will receive placebo (3 tablets) administered vaginally 2-3 hours and 4-6 hours prior to visual inspection with acetic acid (VIA).
Drug: Misoprostol
Participants will receive 600 mcg misoprostol (3 tablets) administered vaginally 2-3 hours and 4-6 hours prior to visual inspection with acetic acid (VIA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion rate from Type 3 transformation zone (TZ) to Types 1 or 2
Time Frame: Approximately 2-3 hours and approximately 4-6 hours since drug administration
The rate of participants with successful transformation from Type 3 (TZ) to Type 1 or 2 (TZ) will be calculated. It is the number of participants who successfully transformed from Type 3 TZ to Type 1 or 2 TZ, divided by the total number of participants in the entire randomized cohort.
Approximately 2-3 hours and approximately 4-6 hours since drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the rate of patients converted from Type 3 TZ to Type 1 or 2 TZ between 2-3 hours and 4-6 hours
Time Frame: Approximately 2-3 hours vs approximately 4-6 hours
The rate of transformation from Type 3 transformation zone (TZ) to Type 1 or 2 TZ between 2-3 hours and 4-6 hours after administering misoprostol will be compared. The rate is calculated as the number of successful transformations within each time period (2-3 hours or 4-6 hours) divided by the total cohort.
Approximately 2-3 hours vs approximately 4-6 hours

Collaborators and Investigators

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

Sponsor

University of Alabama at Birmingham

Collaborators

National Cancer Institute (NCI)
Cameroon Baptist Convention Health

Investigators

  • Principal Investigator: Warner K Huh, MD, University of Alabama at Birmingham

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 (Actual)

February 25, 2025

Primary Completion (Estimated)

November 4, 2027

Study Completion (Estimated)

November 11, 2028

Study Registration Dates

First Submitted

October 18, 2024

First Submitted That Met QC Criteria

October 30, 2024

First Posted (Actual)

November 1, 2024

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-30012879
  • 1R01CA279021 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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