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NCT Number: NCT06669533

Use Misoprostol to Optimize Prevention of Cervical Cancer

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.

Recruiting

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Key information

Conditions

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

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cameroon Baptist Convention Health Core, EtougEbe Baptist Hospital Yaoundé

Yaoundé, Center Region, 2034, Cameroon

Location status: Recruiting

Location contact

Simon M Manga, PhD

CONTACT

[email protected]

2059345612

Simon M Manga, PhD

PRINCIPAL_INVESTIGATOR

Warner K Huh, MD

CONTACT

[email protected]

2059341555

Warner K Huh, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Primary outcomes

  1. 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.

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Simon M Manga, PhD

CONTACT

[email protected]

2059345612

Warner K Huh, MD

CONTACT

[email protected]

2059341555

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Cameroon Baptist Convention Health

Registry information

Official study title

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

Acronym: MISOPCx

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 1, 2024
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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