Goserline Acetate VS Dienogest in Endometriosi

Endometriosis Clinical Trial

Official title:

Goserline Acetate Versus Dienogest in Treatment of Pain Associated With Endometriosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05013242
• Other study ID #: MS.19.09.791.R1
• Status: Recruiting
• Phase: Phase 4
• Start date: December 25, 2020
• Est. completion date: December 25, 2021

Study information

• Verified date: August 2021
• Source: Mansoura University
• Contact: safaa M ismael, resident
• Phone: 00201281857175
• Email: roses_lover_2007[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 25, 2021
• Est. primary completion date: November 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Zoladex
evaluate efficacy of Zoladex in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis
• Visanne
valuate efficacy of Dienogest in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	????????

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with pain symptoms reduction	number of patients with endometriosis-associated pain symptoms reduction	12 week
Secondary	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