Use Misoprostol to Optimize Prevention of Cervical Cancer

Not Applicable

Not yet recruiting

• Conditions: Cervical Cancers
• Interventions: Drug: Placebo; Drug: Misoprostol

• Registration Number: NCT06669533
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-10-18
• Study First Submitted QC: 2024-10-30
• Study First Posted: 2024-11-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05
• Study Start: 2024-12-20
• Primary Completion: 2026-11-04
• Study Completion: 2027-11-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 420

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-pregnant women	Placebo	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).
Non-pregnant women	Misoprostol	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).

Primary Outcome Measures

Name	Time	Method
Conversion rate from Type 3 transformation zone (TZ) to Types 1 or 2	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.

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Cameroon Baptist Convention Health Core, EtougEbe Baptist Hospital Yaoundé; 🇨🇲 Yaoundé, Center Region, Cameroon