Goserline Acetate VS Dienogest in Endometriosi

NCT05013242 — Phase 4, Unknown, 40 participants, Mansoura University

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Goserline Acetate Versus Dienogest in Treatment of Pain Associated With Endometriosis

Registry	NCT05013242
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	40 (Estimated)
Sponsor	Mansoura University (Other)
Conditions	Endometriosis
Interventions	Zoladex, Visanne (Drug)
Dates	start 2020-12-25, primary completion 2021-11-25 (estimated), completion 2021-12-25 (estimated), first posted 2021-08-19, last updated 2021-10-20
Locations	1 site in Egypt

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
group use GnRH	Active comparator	Drug: Zoladex	GnRH (zoladex 3.75mg) injection once every 4 weeks
Group use Visanne (dienogest 2mg) oral once daily for 12 weeks	Active comparator	Drug: Visanne	Visanne (dienogest 2mg) oral once daily for 12 weeks

Zoladex (Drug), also known as Gnrh: evaluate efficacy of Zoladex in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis
Visanne (Drug), also known as Dienogest: valuate efficacy of Dienogest in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis

+Outcome measures

Primary outcomes

number of patients with pain symptoms reduction [12 week]: number of patients with endometriosis-associated pain symptoms reduction

Secondary outcomes

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

+Eligibility

Sex: Female, ages: 18 Years to 45 Years, 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.

+Locations (1)

Facility	City	Country	Status
Mansoura University	Al Mansurah, Dakahlia Governorate	Egypt	Recruiting

+Investigators

Alaa Mosbah, Principal investigator, Mansoura university faculity of medicine , obstetric and gyneclogy department