Goserline Acetate VS Dienogest in Endometriosi

October 12, 2021 updated by: Mansoura University

Goserline Acetate Versus Dienogest in Treatment of Pain Associated With Endometriosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • الدقهلية
      • Mansoura, الدقهلية, Egypt, 35111
        • Recruiting
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group use GnRH
GnRH (zoladex 3.75mg) injection once every 4 weeks
Drug: Zoladex
evaluate efficacy of Zoladex in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis
Other Names:
  • Gnrh
Active Comparator: Group use Visanne (dienogest 2mg) oral once daily for 12 weeks
Visanne (dienogest 2mg) oral once daily for 12 weeks
Drug: Visanne
valuate efficacy of Dienogest in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis
Other Names:
  • Dienogest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients with pain symptoms reduction
Time Frame: 12 week
number of patients with endometriosis-associated pain symptoms reduction
12 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment change in pain severity
Time Frame: 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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Alaa Mosbah, Mansoura university faculity of medicine , obstetric and gyneclogy department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2020

Primary Completion (Anticipated)

November 25, 2021

Study Completion (Anticipated)

December 25, 2021

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

August 18, 2021

First Posted (Actual)

August 19, 2021

Study Record Updates

Last Update Posted (Actual)

October 20, 2021

Last Update Submitted That Met QC Criteria

October 12, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS.19.09.791.R1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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