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

NCT06115408 | Completed Phase 2 DMC

• 1 other identifier: Leiomyoma volume reduction
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Uterine Leiomyoma

Keywords

Fibroids dienogest NAC

Outcome Measures

Primary Outcomes (1)

• leiomyoma size reduction

  vertical x horizontal diameter in mm by transvaginal U/S

  3 months

Secondary Outcomes (3)

• Dysmenorrhea

  3 Monthes

• heavy menstrual bleeding

  3 months

• blood loss

  3 months

Study Arms (2)

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

Dienogest 2 MG DRUG

Clinical trial

Also known as: Gynoprogest

Drug;Dienogest

N-acetyl cysteine DRUG

Clinical trial

Also known as: Gemacysteine

Drug;N-Acetylcysteine

Eligibility Criteria

• Age: 20 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Myofibroma

Interventions

dienogest; Acetylcysteine

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Amr Mahmoud, lecturer

  Ain Shams University

  STUDY CHAIR

• Ahmed mohamed mamdouh, assisstant professor

  Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher,ob/gyn Resident, Principal Investigator, Esraa Awd

Model Details: The study will be conducted on 40 women; they will be subdivided into 2equal groups .each group receive different intervention

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: November 3, 2023
• Study Start: September 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication.no end date
• Access Criteria: Any purpose

Locations

EG (1)