Management of Uterine Leiomyomata and Adenomyosis

Management of Uterine Leiomyomata and Adenomyosis : Role of Hysteroscopy in Diagnosis and Norethisterone in the Treatment

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

Study Overview

• Status: Recruiting
• Conditions: Abnormal Uterine Bleeding
• Intervention / Treatment: Drug: Norethisterone acetate

Detailed Description

The aim of the present study is:

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

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: ahmed Al Dr, Msc; Phone Number: 002024745305 00201003734246; Email: rcogahmedali@gmail.com
• Study Contact Backup: Name: Ahmed Ali; Phone Number: 00201003734246; Email: Drarmy1984@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Ahmed Ali
  • Assiut, Egypt
    • Recruiting
    • Maternaty hospital in assiut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

single arm single center study

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
fibroid cases; Norethisterone acetate for 5 months	Drug: Norethisterone acetate; Norethisterone acetate for 5 months
adenomyosis; Norethisterone acetate for 5 months	Drug: Norethisterone acetate; Norethisterone acetate for 5 months

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ahmed Ali Mahmoud
• Collaborators: Assiut University
• Investigators: Principal Investigator: Hisham Mo Taleb, Md, Assiut University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2021
• Primary Completion (Actual): November 25, 2021
• Study Completion (Anticipated): December 25, 2021

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Actual): December 10, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Diseases; Hemorrhage; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Adenomyosis; Leiomyoma; Myofibroma; Uterine Hemorrhage; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Norethindrone; Norethindrone Acetate
• Other Study ID Numbers: 12091984

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No