Goserline Acetate VS Dienogest in Endometriosi

NCT05013242 | Unknown Phase 4

• 1 other identifier: MS.19.09.791.R1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• number of patients with pain symptoms reduction

  number of patients with endometriosis-associated pain symptoms reduction

  12 week

Secondary Outcomes (1)

• assessment change in pain severity

  12 weeks

Study Arms (2)

group use GnRH

ACTIVE COMPARATOR

GnRH (zoladex 3.75mg) injection once every 4 weeks

Drug: Zoladex

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

ACTIVE COMPARATOR

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

Drug: Visanne

Interventions

Zoladex DRUG

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

Also known as: Gnrh

group use GnRH

Visanne DRUG

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

Also known as: Dienogest

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, 35111, Egypt

RECRUITING

MeSH Terms

Conditions

Endometriosis

Interventions

Goserelin; Gonadotropin-Releasing Hormone; dienogest

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Alaa Mosbah

  Mansoura university faculity of medicine , obstetric and gyneclogy department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

safaa M ismael, resident

CONTACT

00201281857175; roses_lover_2007@hotmail.com

alaa mosbah, prosfeesor

CONTACT

alaamosbah@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: August 19, 2021
• Study Start: December 25, 2020
• Primary Completion: November 25, 2021
• Study Completion: December 25, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)