Evaluation of Using Dienogest and N-Acetyl Cysteine on th... | NCT06115408

Studies
Evaluation of Using Dienogest and N-Acetyl Cysteine on the Volume of Uterine Leiomyoma

NCT06115408

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Dec 16, 2024Actual

Enrollment

40Actual

Phase

Phase 2Phase 3

Conditions

Uterine Leiomyoma

Interventions

Dienogest 2 MG
N-acetyl cysteine

Countries

Egypt

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2023Actual

Primary Completion Date

Aug 31, 2024Actual

Completion Date

Aug 31, 2024Actual

First Submitted Date

Mar 9, 2023

First Submission Date that Met QC Criteria

Oct 29, 2023

First Posted Date

Nov 3, 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

Dec 13, 2024

Last Update Posted Date

Dec 16, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Esraa Mosaad Awd El-sayed, Researcher,ob/gyn Resident, Principal Investigator, Esraa Awd, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This 2 arm randomized clinical trial will assess the impact of Dienogest and N-Acetyl Cysteine on volume reduction of uterine leiomyoma

Detailed Description

Group A women will receive Dienogest orally 2mg pills daily for 3 months .20 cases Group B women will receive NAC orally at a dose of 600 mg/day for 3 months ,20 cases

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Drug;Dienogest	Experimental	2mg pills oral daily	Drug: Dienogest 2 MG
Drug;N-Acetylcysteine	Experimental	600 mg/day oral daily	Drug: N-acetyl cysteine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dienogest 2 MG	Drug	Clinical trial	Drug;Dienogest	Gynoprogest

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
leiomyoma size reduction	vertical x horizontal diameter in mm by transvaginal U/S	3 months

Secondary Outcomes

Measure	Description	Time Frame
Dysmenorrhea	according to the visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)	3 Monthes
heavy menstrual bleeding

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: 20-45 years.
Women with uterine leiomyoma (sub-mucous, sub-serous or intramural) based on transvaginal sonography criteria. Uterine fibroids most often appear as concentric, solid, hypoechoic masses. This appearance results from the prevailing muscle, which is observed at histologic examination. These solid masses absorb sound waves and therefore cause a variable amount of acoustic shadowing.
Regular menstruation: regular period interval from 21 to 35 days.

Exclusion Criteria:

Pregnant or menopausal women.
History of malignancies, metabolic, hematologic, cardiac, thromboembolism, diabetes, renal or hepatic diseases.
History of hormonal drug use or treatment for leiomyoma in the past 3 months.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amr Mahmoud, lecturer	Ain Shams University	Study Chair
Ahmed mohamed mamdouh, assisstant professor	Ain Shams University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ainshams University		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All of individual participant data collecting during the trial ,after deidentification

Types

Study Protocol

Time Frame

Immediately following publication.no end date

Access Criteria

Any purpose

URL

https://med.asu.edu.eg

Type	Date	Date Unknown
Release	Dec 21, 2024
Reset	Jan 21, 2025

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 31, 2024	Dec 13, 2024	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Oct 31, 2024	Dec 13, 2024	SAP_001.pdf
ICF	No	No	Yes	Informed Consent Form	Oct 31, 2024	Dec 13, 2024	ICF_002.pdf

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 21, 2024			Jan 21, 2025

Condition Browse Module

MeSH Terms

ID	Term
D047708	Myofibroma

Ancestor Terms

ID	Term
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C023635	dienogest
D000111	Acetylcysteine

Ancestor Terms

ID	Term
D003545	Cysteine
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided