Goserline Acetate VS Dienogest in Endometriosi

Mansoura University

Status and phase: Unknown; Phase 4

Conditions: Endometriosis

Treatments: Drug: Visanne; Drug: Zoladex

Study type: Interventional

Funder types: Other

Identifiers

NCT05013242

MS.19.09.791.R1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

group use GnRH

Active Comparator group

Description:

GnRH (zoladex 3.75mg) injection once every 4 weeks

Treatment:

Drug: Zoladex

Group use Visanne (dienogest 2mg) oral once daily for 12 weeks

Active Comparator group

Description:

Visanne (dienogest 2mg) oral once daily for 12 weeks

Treatment:

Drug: Visanne