NCT05675293

Brief Summary

The purpose of the study is to: Investigate effect of iontophoresis on managing uterine cervicitis.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jan 2023

Shorter than P25 for early_phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

17 days

First QC Date

December 29, 2022

Last Update Submit

January 9, 2023

Conditions

CERVICITIS

Outcome Measures

Primary Outcomes (1)

  • 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

    7 Days difference between pre and post tests

Study Arms (2)

EXPERIMENTAL ARM

EXPERIMENTAL
Device: IONTOPHORESIS

CONTROL ARM

ACTIVE COMPARATOR
Drug: ORAL ANTIBIOTIC

Interventions

IONTOPHORESISDEVICE

The process of increasing the penetration of drugs into the skin by application of an electric current

EXPERIMENTAL ARM
ORAL ANTIBIOTICDRUG

Oral Antibiotic

CONTROL ARM

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervicitis

Interventions

IontophoresisAnti-Bacterial Agents

Condition Hierarchy (Ancestors)

Uterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsElectrophoresisElectrochemical TechniquesInvestigative TechniquesAnti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

MARIAM HELMY, DEMONSTRATOR

CONTACT

01129985772MARIAMHELMYMHR@GMAIL.COM

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Practitioner

Study Record Dates

First Submitted

December 29, 2022

First Posted

January 9, 2023

Study Start

January 15, 2023

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

January 11, 2023

Record last verified: 2023-01