Cervicitis by Iontophoresis | NCT05675293

Studies
Cervicitis by Iontophoresis

NCT05675293

Sponsor

October 6 University

Status

Unknown status

Last Update Posted

Jan 11, 2023Actual

Enrollment

40Estimated

Phase

Early Phase 1

Conditions

CERVICITIS

Interventions

IONTOPHORESIS
ORAL ANTIBIOTIC

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2023Estimated

Primary Completion Date

Feb 2023Estimated

Completion Date

Feb 2023Estimated

First Submitted Date

Dec 29, 2022

First Submission Date that Met QC Criteria

Dec 29, 2022

First Posted Date

Jan 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2023

Last Update Posted Date

Jan 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to:

Investigate effect of iontophoresis on managing uterine cervicitis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EXPERIMENTAL ARM	Experimental		Device: IONTOPHORESIS
CONTROL ARM	Active Comparator		Drug: ORAL ANTIBIOTIC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IONTOPHORESIS	Device	The process of increasing the penetration of drugs into the skin by application of an electric current	EXPERIMENTAL ARM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
MARIAM HELMY, DEMONSTRATOR	Contact	01129985772		MARIAMHELMYMHR@GMAIL.COM

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002575	Uterine Cervicitis

Ancestor Terms

ID	Term
D002577	Uterine Cervical Diseases
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007478	Iontophoresis
D000900	Anti-Bacterial Agents

Ancestor Terms

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics
D004586	Electrophoresis

Browse Leaves

Not provided

Browse Branches

Not provided