An interventional study of Placebo and Misoprostol in Cervical Cancers, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in Cameroon. Open to female participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Screening
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.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 840 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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).
Drug: Placebo · Drug: Misoprostol
Participants will receive placebo (3 tablets) administered vaginally 2-3 hours and 4-6 hours prior to visual inspection with acetic acid (VIA).
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).
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
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
Plan to share: No — Individual participant data (IPD) will not be shared publicly because the study collects sensitive personal and health information from participants, and broad data sharing could compromise participant privacy and confidentiality despite de-identification efforts. In addition, the informed consent process and ethics approvals did not include provisions for unrestricted public sharing of individual-level data. Access to study data will therefore remain restricted to the study investigators and authorized personnel for approved research purposes, in accordance with institutional policies, ethical approvals, and applicable data protection requirements.
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Nov 2027, 32 months after the start.
Of 445 non-industry interventional studies with no phase under Uterine Cervical Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 71. This study's planned 32 months is close to that.
Counting every sponsor, half of 461 studies reached it within 33 months; a quarter within 15 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Misoprostol
University of Alabama at Birmingham →