Goserline Acetate VS Dienogest in Endometriosi

Study Overview
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Brief Summary
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clinical trial aims to evaluate efficacy of dienogest (DNG) in comparison to goserline acetate in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis by laparoscopy and histopathology.

Detailed Description
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The study will be a clinical trial study of 12-week trial of GnRH (zoladex 3.75mg) injection once every 4 weeks and Visanne (dienogest 2mg) oral once daily for 12 weeks in patients confirmed endometriosis by laparoscopic surgery. Pretreatment assessment, the patients will be questioned about their pelvic symptoms (dysmenorrhea, nonmenstrual pelvic pain, and deep dyspareunia) after taking full history and examination , The study will investigate and evaluate possible early, long side effects and efficacy of treatment to controlling the pain.

Official Title
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Goserline Acetate Versus Dienogest in Treatment of Pain Associated With Endometriosis

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: Zoladex
* Drug: Visanne


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non pregnant women confirmed to have endometriosis by histopathology and not received any hormonal treatment yet. Also, medical treatment was the proper choice for treatment of each case. Exclusion Criteria: Women suspect pregnancy. Breast feeding women. Previous use of hormonal agents (progestin less than 6 months, danazol less than 3 month, oral contraceptive pills less than 1 month before screening). Women with other gynecological pathology interfere with treatment we will use. Using of corticosteroids. Family history of osteoporosis.

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group use GnRH<br>GnRH (zoladex 3.75mg) injection once every 4 weeks | Drug: Zoladex<br>* evaluate efficacy of Zoladex in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis<br>* Other names: Gnrh;|
| Active Comparator: Group use Visanne (dienogest 2mg) oral once daily for 12 weeks<br>Visanne (dienogest 2mg) oral once daily for 12 weeks | Drug: Visanne<br>* valuate efficacy of Dienogest in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis<br>* Other names: Dienogest;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with pain symptoms reduction | number of patients with endometriosis-associated pain symptoms reduction | 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment change in pain severity | pain severity assessment after treatment by visual analogue scale as determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark providing a range of scores from 0-100 | 12 weeks |