Use Misoprostol to Optimize Prevention of Cervical Cancer

NCT06669533 | Recruiting DMC

• 2 other identifiers: IRB-300128791R01CA279021
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancers

Keywords

cervical cancers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

  Approximately 2-3 hours vs approximately 4-6 hours

Study Arms (1)

Non-pregnant women

EXPERIMENTAL

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; Drug: Misoprostol

Interventions

Placebo DRUG

Participants will receive placebo (3 tablets) administered vaginally 2-3 hours and 4-6 hours prior to visual inspection with acetic acid (VIA).

Non-pregnant women

Misoprostol DRUG

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).

Non-pregnant women

Eligibility Criteria

• Age: 25 Years+
• Gender Eligibility Details: Non-pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Cameroon Baptist Convention Health Core: collaborator

Study Sites (1)

Cameroon Baptist Convention Health Core, EtougEbe Baptist Hospital Yaoundé

Yaoundé, Center Region, 2034, Cameroon

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Warner K Huh, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Warner K Huh, MD

CONTACT

2059341555; whuh@uabmc.edu

Simon M Manga, PhD

CONTACT

2059345612; smanga@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The PIs, nurses who will be providing the drugs, and study participants will be blinded in the study.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: November 1, 2024
• Study Start: February 25, 2025
• Primary Completion (Estimated): November 4, 2026
• Study Completion (Estimated): November 4, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-07

Locations

CA (1)