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

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

Detailed Description
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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

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

Conditions
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Uterine Leiomyoma

Intervention / Treatment
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* Drug: Dienogest 2 MG
* Drug: N-acetyl cysteine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be conducted on 40 women; they will be subdivided into 2equal groups .each group receive different intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug;Dienogest<br>2mg pills oral daily | Drug: Dienogest 2 MG<br>* Clinical trial<br>* Other names: Gynoprogest;|
| Experimental: Drug;N-Acetylcysteine<br>600 mg/day oral daily | Drug: N-acetyl cysteine<br>* Clinical trial<br>* Other names: Gemacysteine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leiomyoma volume change | Measure leiomyoma volume change in 3 dimensions in cm | 3 Monthes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysmenorrhea | according to the visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain) | 3 Monthes | 
| Heavy menstrual bleeding | assess any abnormal uterine bleeding (AUB) by FIGO System is according to frequency, duration, regularity and flow volume. | 3months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibroids dienogest NAC