EndometriosisPhase 4NCT05013242
Goserline Acetate VS Dienogest in Endometriosi
A Phase 4 study testing Zoladex and Visanne in people with Endometriosis, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- Zoladex and Visanne
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Dec 2020to 25 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
alaa mosbah, prosfeesor contact
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University
Al Mansurah, Dakahlia Governorate, 35111
About this study
Official title: 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.
Read the 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.
- Conditions
- Endometriosis
- Being tested
- Zoladex, Visanne
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZoladexDrug
Also called Gnrh
evaluate efficacy of Zoladex in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis
VisanneDrug
Also called Dienogest
valuate efficacy of Dienogest in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis
| Study group | Role | What they receive |
|---|---|---|
| group use GnRH | Active comparator | GnRH (zoladex 3.75mg) injection once every 4 weeks Receives: Drug: Zoladex |
| Group use Visanne (dienogest 2mg) oral once daily for 12 weeks | Active comparator | Visanne (dienogest 2mg) oral once daily for 12 weeks Receives: Drug: Visanne |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with pain symptoms reduction
number of patients with endometriosis-associated pain symptoms reduction
Measured: 12 week
Secondary outcomes (1)
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start25 Dec 2020
- Primary completion25 Nov 2021 (estimated)
- Study completion25 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alaa Mosbah, Principal investigator, Mansoura university faculity of medicine , obstetric and gyneclogy department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013242
- Sponsor's protocol ID
- MS.19.09.791.R1
- Status last verified
- Aug 2021
- First submitted
- 20 Apr 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goserline Acetate Versus Dienogest in Treatment of Pain Associated With Endometriosis
- ClinicalTrials.gov ID
- NCT05013242
- Acronym / sponsor ID
- MS.19.09.791.R1
- Conditions
- Endometriosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 25 Dec 2020 (actual)
- Primary completion
- 25 Nov 2021 (estimated)
- Study completion
- 25 Dec 2021 (estimated)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group use GnRH | Active comparator | Drug: ZoladexGnRH (zoladex 3.75mg) injection once every 4 weeks |
| Group use Visanne (dienogest 2mg) oral once daily for 12 weeks | Active comparator | Drug: VisanneVisanne (dienogest 2mg) oral once daily for 12 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZoladexAlso: Gnrhevaluate efficacy of Zoladex in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis | Drug | group use GnRH |
| VisanneAlso: Dienogestvaluate efficacy of Dienogest in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis | Drug | Group use Visanne (dienogest 2mg) oral once daily for 12 weeks |
Primary outcome
number of patients with pain symptoms reduction
Time frame: 12 week
number of patients with endometriosis-associated pain symptoms reduction
1 secondary outcome
assessment change in pain severity
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
alaa mosbah, prosfeesor contact
Alaa Mosbah principal investigator
Mansoura university faculity of medicine , obstetric and gyneclogy department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zoladex and Visanne in people with Endometriosis, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact safaa M ismael, resident (00201281857175, roses_lover_2007@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with pain symptoms reduction (time frame: 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.