CERVICITISEarly Phase 1NCT05675293
Cervicitis by Iontophoresis
A Early Phase 1 study testing IONTOPHORESIS and ORAL ANTIBIOTIC in people with CERVICITIS, run by October 6 University.
Trial summary
The purpose of the study is to: Investigate effect of iontophoresis on managing uterine cervicitis. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- CERVICITIS
- What is being tested?
- IONTOPHORESIS and ORAL ANTIBIOTIC
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2023to Feb 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All patients have vaginal discharge.
- All patients have irregular vaginal bleeding, especially after sexual intercourse.
- All patients have dyspareunia.
- All patients have Lower abdominal pain.
- Group A: 20 women will receive oral medication (antibiotic zesrosin) and hot water with antiseptic.
- Group B: 20 women will receive medication by iontophoresis (antibiotic ceftriaxone) and hot water with antiseptic.
Who cannot join
- Patients with a history of hypersensitivity or adverse reactions associated with the delivered drug in (ceftriaxone).
- Patients with prior medical histories of cardiac arrhythmias or hypercoagulability should not receive the procedure near cardiac pacemakers and superficial blood vessels.
- In the vicinity of embedded wires, stapes, orthopedic implants, and areas of skin with lesions and impaired sensation.
- It either should not be used or used with extreme caution during pregnancy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Iontophoresis in Managing Uterine Cervicitis
The purpose of the study is to:
Investigate effect of iontophoresis on managing uterine cervicitis.
- Conditions
- CERVICITIS
- Being tested
- IONTOPHORESIS, ORAL ANTIBIOTIC
- Medical subject headings
- Uterine Cervicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IONTOPHORESISDevice
The process of increasing the penetration of drugs into the skin by application of an electric current
ORAL ANTIBIOTICDrug
Oral Antibiotic
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL ARM | Experimental | Not described Receives: Device: IONTOPHORESIS |
| CONTROL ARM | Active comparator | Not described Receives: Drug: ORAL ANTIBIOTIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in change in Urine Analysis and Cervical swab results in both groups
Presence of Pus Cells in Urine Analysis and a Positive Cervical swab results
Measured: 7 Days difference between pre and post tests
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start15 Jan 2023 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CERVICITISStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIAM HELMY, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675293
- Sponsor's protocol ID
- IONTOPHORESIS FOR CERVICITIS
- Status last verified
- Jan 2023
- First submitted
- 29 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Iontophoresis in Managing Uterine Cervicitis
- ClinicalTrials.gov ID
- NCT05675293
- Acronym / sponsor ID
- IONTOPHORESIS FOR CERVICITIS
- Conditions
- CERVICITIS
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 9 Jan 2023 (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.
The purpose of the study is to:
Investigate effect of iontophoresis on managing uterine cervicitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL ARM | Experimental | Device: IONTOPHORESIS |
| CONTROL ARM | Active comparator | Drug: ORAL ANTIBIOTIC |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- All patients have vaginal discharge.
- All patients have irregular vaginal bleeding, especially after sexual intercourse.
- All patients have dyspareunia.
- All patients have Lower abdominal pain.
- Group A: 20 women will receive oral medication (antibiotic zesrosin) and hot water with antiseptic.
Key exclusion criteria (4 listed)
- Patients with a history of hypersensitivity or adverse reactions associated with the delivered drug in (ceftriaxone).
- Patients with prior medical histories of cardiac arrhythmias or hypercoagulability should not receive the procedure near cardiac pacemakers and superficial blood vessels.
- In the vicinity of embedded wires, stapes, orthopedic implants, and areas of skin with lesions and impaired sensation.
- It either should not be used or used with extreme caution during pregnancy.
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 |
|---|---|---|
| IONTOPHORESISThe process of increasing the penetration of drugs into the skin by application of an electric current | Device | EXPERIMENTAL ARM |
| ORAL ANTIBIOTICOral Antibiotic | Drug | CONTROL ARM |
Primary outcome
Difference in change in Urine Analysis and Cervical swab results in both groups
Time frame: 7 Days difference between pre and post tests
Presence of Pus Cells in Urine Analysis and a Positive Cervical swab results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
Related trials for CERVICITIS
Not yet recruitingObservational study
VIA Versus Colposcopy
Cervical Intraepithelial Neoplasia (CIN), Cervicitis
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing IONTOPHORESIS and ORAL ANTIBIOTIC in people with CERVICITIS, run by October 6 University.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MARIAM HELMY, DEMONSTRATOR (01129985772, MARIAMHELMYMHR@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in change in Urine Analysis and Cervical swab results in both groups (time frame: 7 Days difference between pre and post tests). 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 11 Jan 2023; AzTrials last refreshed its copy on 30 Oct 2026.