Goserline Acetate VS Dienogest in Endometriosi

Phase 4

• Conditions: Endometriosis
• Interventions: Drug: Zoladex; Drug: Visanne

• Registration Number: NCT05013242
• Lead Sponsor: Mansoura University

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-12-25
• Study First Submitted: 2021-04-20
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-19
• Last Update Submitted: 2021-10-12
• Last Update Posted: 2021-10-20
• Primary Completion: 2021-11-25
• Study Completion: 2021-12-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group use GnRH	Zoladex	GnRH (zoladex 3.75mg) injection once every 4 weeks
Group use Visanne (dienogest 2mg) oral once daily for 12 weeks	Visanne	Visanne (dienogest 2mg) oral once daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
number of patients with pain symptoms reduction	12 week	number of patients with endometriosis-associated pain symptoms reduction

Secondary Outcome Measures

Name	Time	Method
assessment change in pain severity	12 weeks	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

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, الدقهلية, Egypt