Goserline Acetate VS Dienogest in Endometriosi

NCT ID: NCT05013242

Last Updated: 2021-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-25

Study Completion Date

2021-12-25

Brief Summary

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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

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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.

Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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group use GnRH

GnRH (zoladex 3.75mg) injection once every 4 weeks

Group Type ACTIVE_COMPARATOR

Zoladex

Intervention Type DRUG

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

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

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

Group Type ACTIVE_COMPARATOR

Visanne

Intervention Type DRUG

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

Interventions

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Zoladex

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

Intervention Type DRUG

Visanne

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

Intervention Type DRUG

Other Intervention Names

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Gnrh Dienogest

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alaa Mosbah

Role: PRINCIPAL_INVESTIGATOR

Mansoura university faculity of medicine , obstetric and gyneclogy department

Locations

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Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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safaa M ismael, resident

Role: CONTACT

00201281857175

alaa mosbah, prosfeesor

Role: CONTACT

Other Identifiers

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MS.19.09.791.R1

Identifier Type: -

Identifier Source: org_study_id