Evaluation of Using Dienogest and N-Acetyl Cysteine on the Volume of Uterine Leiomyoma
NCT ID: NCT06115408
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
40 participants
INTERVENTIONAL
2023-09-01
2024-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Drug;Dienogest
2mg pills oral daily
Dienogest 2 MG
Clinical trial
Drug;N-Acetylcysteine
600 mg/day oral daily
N-acetyl cysteine
Clinical trial
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dienogest 2 MG
Clinical trial
N-acetyl cysteine
Clinical trial
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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.
3. Regular menstruation: regular period interval from 21 to 35 days.
Exclusion Criteria
2. History of malignancies, metabolic, hematologic, cardiac, thromboembolism, diabetes, renal or hepatic diseases.
3. History of hormonal drug use or treatment for leiomyoma in the past 3 months.
20 Years
45 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ain Shams University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Esraa Mosaad Awd El-sayed
Researcher,ob/gyn Resident, Principal Investigator, Esraa Awd
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Amr Mahmoud, lecturer
Role: STUDY_CHAIR
Ain Shams University
Ahmed mohamed mamdouh, assisstant professor
Role: STUDY_CHAIR
Ain Shams University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ainshams University
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Leiomyoma volume reduction
Identifier Type: -
Identifier Source: org_study_id