Endometriosis
Conditions
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.
Interventions
DRUGZoladex
evaluate efficacy of Zoladex in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis
DRUGVisanne
valuate efficacy of Dienogest in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patients with pain symptoms reduction | 12 week | number of patients with endometriosis-associated pain symptoms reduction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Contacts
Primary Contactsafaa M ismael, resident
Backup Contactalaa mosbah, prosfeesor
Outcome results
None listed