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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group use GnRH | Active Comparator | GnRH (zoladex 3.75mg) injection once every 4 weeks |
|
| Group use Visanne (dienogest 2mg) oral once daily for 12 weeks | Active Comparator | Visanne (dienogest 2mg) oral once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoladex | Drug | evaluate efficacy of Zoladex in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of patients with pain symptoms reduction | number of patients with endometriosis-associated pain symptoms reduction | 12 week |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| safaa M ismael, resident | Contact | 00201281857175 | roses_lover_2007@hotmail.com | |
| alaa mosbah, prosfeesor | Contact | alaamosbah@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alaa Mosbah | Mansoura university faculity of medicine , obstetric and gyneclogy department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University | Recruiting | Al Mansurah | Dakahlia Governorate | 35111 | Egypt |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D017273 | Goserelin |
| D007987 | Gonadotropin-Releasing Hormone |
| C023635 | dienogest |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| Visanne | Drug | valuate efficacy of Dienogest in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis |
|
|
| D000091662 | Genital Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |