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Trial · Interventional

Status unknownPhase 4Registry data

Goserline Acetate VS Dienogest in Endometriosi

NCTNCT05013242 (opens ClinicalTrials.gov in a new tab)Other idMS.19.09.791.R1
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
40 participants (estimated)
Sponsor
Mansoura University · Other
Design
Randomized · Single masking
Countries
1 country

Egypt

Start
25 Dec 2020
Primary completion
25 Nov 2021 (estimated)
Completion
25 Dec 2021 (estimated)
First posted
19 Aug 2021
Last update posted
20 Oct 2021
Conditions
Endometriosis

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202020212022
  1. Ph 4

    Goserline Acetate VS Dienogest in Endometriosi

    NCT05013242

    25 Dec 2020 to est. 25 Dec 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • ZoladexDrug
  • VisanneDrug

Arms2

  • Active comparator

    group use GnRH

    GnRH (zoladex 3.75mg) injection once every 4 weeks

  • Active comparator

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

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. number of patients with pain symptoms reduction

    Time frame · 12 week

    Registry description

    number of patients with endometriosis-associated pain symptoms reduction

Secondary outcomes(1)

  1. assessment change in pain severity

    Time frame · 12 weeks

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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