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Trial Title:
Evaluation of Using Dienogest and N-Acetyl Cysteine on the Volume of Uterine Leiomyoma
NCT ID:
NCT06115408
Condition:
Uterine Leiomyoma
Conditions: Official terms:
Leiomyoma
Myofibroma
Acetylcysteine
Dienogest
N-monoacetylcystine
Conditions: Keywords:
Fibroids dienogest NAC
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The study will be conducted on 40 women; they will be subdivided into 2equal groups .each
group receive different intervention
Primary purpose:
Health Services Research
Masking:
Single (Care Provider)
Intervention:
Intervention type:
Drug
Intervention name:
Dienogest 2 MG
Description:
Clinical trial
Arm group label:
Drug;Dienogest
Other name:
Gynoprogest
Intervention type:
Drug
Intervention name:
N-acetyl cysteine
Description:
Clinical trial
Arm group label:
Drug;N-Acetylcysteine
Other name:
Gemacysteine
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: 20-45 years.
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:
1. Pregnant or menopausal women.
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.
Gender:
Female
Gender based:
Yes
Minimum age:
20 Years
Maximum age:
45 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Ainshams University
Address:
City:
Cairo
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Fatma Ebeid
Email:
dr.fatma_ebeid@yahoo.com
Start date:
July 1, 2023
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Ain Shams University
Agency class:
Other
Source:
Ain Shams University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06115408
