Cervical Cancers
Conditions
Keywords
cervical cancers
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.
Interventions
DRUGPlacebo
Participants will receive placebo (3 tablets) administered vaginally 2-3 hours and 4-6 hours prior to visual inspection with acetic acid (VIA).
DRUGMisoprostol
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).
Sponsors
University of Alabama at Birmingham
Cameroon Baptist Convention Health
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Masking description
The PIs, nurses who will be providing the drugs, and study participants will be blinded in the study.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Cameroon
Contacts
CONTACTWarner K Huh, MD
CONTACTSimon M Manga, PhD
PRINCIPAL_INVESTIGATORWarner K Huh, MD
University of Alabama at Birmingham
Outcome results
None listed