Use Misoprostol to Optimize Prevention of Cervical Cancer (MISOPCx)

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Cervical Cancers

Treatments: Drug: Misoprostol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06669533

1R01CA279021 (U.S. NIH Grant/Contract)

IRB-30012879

Details and patient eligibility

About

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.

Enrollment: 420 estimated patients

Sex: Female

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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420 participants in 1 patient group

Non-pregnant women

Experimental group

Description:

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).

Treatment:

Drug: Placebo

Drug: Misoprostol