Management of Uterine Leiomyomata and Adenomyosis | NCT05153928

Studies
Management of Uterine Leiomyomata and Adenomyosis

NCT05153928

Sponsor

Ahmed Ali Mahmoud

Status

Unknown status

Last Update Posted

Dec 10, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Abnormal Uterine Bleeding

Interventions

Norethisterone acetate

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

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

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 10, 2021Actual

Primary Completion Date

Nov 25, 2021Actual

Completion Date

Dec 25, 2021Estimated

First Submitted Date

Nov 30, 2021

First Submission Date that Met QC Criteria

Nov 30, 2021

First Posted Date

Dec 10, 2021Actual

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

Nov 30, 2021

Last Update Posted Date

Dec 10, 2021Actual

Name	Class
Assiut University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

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

to determine the role of hysteroscopy and guided biopsy to differentiate between submucosal fibroids and adenomyosis confirmed by histopathological examination
to evaluate the efficacy of norethisterone in the treatment of symptomatic adenomyosis and leiomyoma

Detailed Description

The aim of the present study is:

to determine the role of hysteroscopy and guided biopsy to differentiate between submucosal fibroids and adenomyosis confirmed by histopathological examination
to evaluate the efficacy of norethisterone in the treatment of symptomatic adenomyosis and leiomyoma

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fibroid cases		Norethisterone acetate for 5 months	Drug: Norethisterone acetate
adenomyosis		Norethisterone acetate for 5 months	Drug: Norethisterone acetate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Norethisterone acetate	Drug	Norethisterone acetate for 5 months	adenomyosis fibroid cases

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
is to evaluate sensitivity and specificity of hysteroscopy in differentiating between uterine adenomyosis and leiomyomatosis	Symptomatic improvement	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- (1) age≥30 years; (4) dysmenorrhea, adenomyosis-associated chronic pain, and/or menorrhagia.

(3) regular menstrual cycles before administration of norethisterone; (4) no other treatment for adenomyosis/leiomyomatosis at least for 3 months biopsies and histopathology for operated patients;

Exclusion Criteria:

(1) pregnant and/or breast-feeding women (2) patients with a ovarian neoplasm, benign ovarian cyst including endometrioma, pelvic inflammatory disease or other endocrine diseases.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

single arm single center study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ahmed Al Dr, Msc	Contact	00201003734246	002024745305	rcogahmedali@gmail.com
Ahmed Ali	Contact	00201003734246		Drarmy1984@gmail.com

Overall Officials

Name	Affiliation	Role
Hisham Mo Taleb, Md	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Ali	Recruiting	Asyut			Egypt
Maternaty hospital in assiut

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19881092	Background	Wilde S, Scott-Barrett S. Radiological appearances of uterine fibroids. Indian J Radiol Imaging. 2009 Jul-Sep;19(3):222-31. doi: 10.4103/0971-3026.54887.

ID	Term
D014592	Uterine Hemorrhage
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

ID	Term
D009640	Norethindrone
D009652	Norpregnenes
D009650	Norpregnanes
D009654	Norsteroids