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Goserline Acetate VS Dienogest in Endometriosi

Primary Purpose

Endometriosis

Status

Unknown status

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Zoladex

Visanne

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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.

Sites / Locations

Mansoura UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

group use GnRH

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

Arm Description

GnRH (zoladex 3.75mg) injection once every 4 weeks

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

Outcomes

Primary Outcome Measures

number of patients with pain symptoms reduction

number of patients with endometriosis-associated pain symptoms reduction

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05013242

First Posted

April 20, 2021

Last Updated

October 12, 2021

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT05013242

Brief Title

Goserline Acetate VS Dienogest in Endometriosi

Official Title

Goserline Acetate Versus Dienogest in Treatment of Pain Associated With Endometriosis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 25, 2020 (Actual)

Primary Completion Date

November 25, 2021 (Anticipated)

Study Completion Date

December 25, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometriosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

group use GnRH

Arm Type

Active Comparator

Arm Description

GnRH (zoladex 3.75mg) injection once every 4 weeks

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Zoladex

Other Intervention Name(s)

Gnrh

Intervention Description

evaluate efficacy of Zoladex in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis

Intervention Type

Drug

Intervention Name(s)

Visanne

Other Intervention Name(s)

Dienogest

Intervention Description

valuate efficacy of Dienogest in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis

Primary Outcome Measure Information:

Title

number of patients with pain symptoms reduction

Description

number of patients with endometriosis-associated pain symptoms reduction

Time Frame

12 week

Secondary Outcome Measure Information:

Title

assessment change in pain severity

Description

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

safaa M ismael, resident

Phone

00201281857175

roses_lover_2007@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

alaa mosbah, prosfeesor

alaamosbah@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alaa Mosbah

Organizational Affiliation

Mansoura university faculity of medicine , obstetric and gyneclogy department

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mansoura University

City

Mansoura

State/Province

الدقهلية

ZIP/Postal Code

35111

Country

Egypt

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Goserline Acetate VS Dienogest in Endometriosi

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