Cervical CancersMISOPCxNCT06669533
Use Misoprostol to Optimize Prevention of Cervical Cancer
A study testing Misoprostol in people with Cervical Cancers, run by University of Alabama at Birmingham at 1 site in Cameroon.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancers
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 840 participants
- Where
- 1 siteCameroon
- Study dates
- 25 Feb 2025to 11 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of Type 3 TZ confirmed on exam prior to randomization
- Age 25 years or older
Who cannot join
- With Type 1 or 2 TZ prior to randomization
- Currently pregnant
- History of hysterectomy
- Any cancerous lesions
- Active cervicitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cameroon1 site, 1 recruiting
- Recruiting
Cameroon Baptist Convention Health Core, EtougEbe Baptist Hospital Yaoundé
Yaoundé, Center Region, 2034
Simon M Manga, PhD, 2059345612, smanga@uab.edu
Warner K Huh, MD, 2059341555, whuh@uabmc.edu
About this study
Official title: Misoprostol to Optimizing Prevention of Cancer of the Cervix: A Double-Blind Randomized Controlled 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.
- Conditions
- Cervical Cancers
- Being tested
- Placebo, Misoprostol
- Keywords
- cervical cancers
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Participants will receive placebo (3 tablets) administered vaginally 2-3 hours and 4-6 hours prior to visual inspection with acetic acid (VIA).
MisoprostolDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Non-pregnant women | Experimental | 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). Receives: Drug: Placebo; Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 2-3 hours and approximately 4-6 hours since drug administration
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
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.
Measured: Approximately 2-3 hours vs approximately 4-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start25 Feb 2025
- Primary completion4 Nov 2027 (estimated)
- Study completion11 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancersStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Cameroon Baptist Convention Health, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Warner Huh, University of Alabama at Birmingham
- Investigators
- Warner K Huh, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669533
- Sponsor's protocol ID
- IRB-30012879
- Other IDs
- 1R01CA279021
- Acronym
- MISOPCx
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misoprostol to Optimizing Prevention of Cancer of the Cervix: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06669533
- Acronym / sponsor ID
- MISOPCx / IRB-30012879
- Conditions
- Cervical Cancers
- Keywords
- cervical cancers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Cameroon Baptist Convention Health, National Cancer Institute (NCI)
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 4 Nov 2027 (estimated)
- Study completion
- 11 Nov 2028 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-pregnant women | Experimental | Drug: Placebo, Drug: MisoprostolNon-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). |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Type 3 TZ confirmed on exam prior to randomization
- Age 25 years or older
Key exclusion criteria (5 listed)
- With Type 1 or 2 TZ prior to randomization
- Currently pregnant
- History of hysterectomy
- Any cancerous lesions
- Active cervicitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboParticipants will receive placebo (3 tablets) administered vaginally 2-3 hours and 4-6 hours prior to visual inspection with acetic acid (VIA). | Drug | Non-pregnant women |
| MisoprostolParticipants will receive 600 mcg misoprostol (3 tablets) administered vaginally 2-3 hours and 4-6 hours prior to visual inspection with acetic acid (VIA). | Drug | Non-pregnant women |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Warner K Huh, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol in people with Cervical Cancers, run by University of Alabama at Birmingham at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Warner K Huh, MD (2059341555, whuh@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.