Use Misoprostol to Optimize Prevention of Cervical Cancer

ConditionCervical Cancers

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age25+

SponsorUniversity of Alabama at Birmingham

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Diagnosis of Type 3 TZ confirmed on exam prior to randomization

Age 25 years or older

Disqualifiers

With Type 1 or 2 TZ prior to randomization

Currently pregnant

History of hysterectomy

Any cancerous lesions

Trial design

Design model

Single group

Treatments tested in this trial

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).

Treatment groups

420 Participants

are divided into 1 treatment group

Group A: Non-pregnant womenExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

Approximately 2-3 hours and approximately 4-6 hours since drug administration

Secondary outcomes

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.

Time frame

Approximately 2-3 hours vs approximately 4-6 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Cameroon Baptist Convention Health

Collaborator

National Cancer Institute (NCI)