Use Misoprostol to Optimize Prevention of Cervical Cancer (MISOPCx)

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: Cervical Cancers
• Intervention / Treatment: Drug: Placebo; Drug: Misoprostol

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Not Applicable

Contacts and Locations

• 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: Warner K Huh, MD; Phone Number: 2059341555; Email: whuh@uabmc.edu
      • Contact: Simon M Manga, PhD; Phone Number: 2059345612; Email: smanga@uab.edu
      • Principal Investigator: Simon M Manga, PhD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	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

• Sponsor: University of Alabama at Birmingham
• Collaborators: Cameroon Baptist Convention Health Core
• Investigators: Principal Investigator: Warner K Huh, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Estimated): November 4, 2026
• Study Completion (Estimated): November 4, 2027

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 (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: cervical cancers
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms; Fatty Acids; Lipids; Biological Factors; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Autacoids; Inflammation Mediators; Prostaglandins E, Synthetic; Misoprostol
• 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