Premature Ovarian FailurePhase 2NCT04536467
Prevention of Chemotherapy-Induced Ovarian Failure With Goserelin in Premenopausal Lymphoma Patients
A Phase 2 study testing Goserelin and Chemotherapy in people with Premature Ovarian Failure, run by Beni-Suef University at 1 site in Egypt.
Trial summary
To Prevent Chemotherapy Induced Ovarian Failure with the gonadotropin-releasing hormone Agonist Goserelin in Young female Lymphoma Cancer patients Receiving Chemotherapy Read more about this study
- Who is it for?
- Ages 17 to 40 years, women only
- Conditions the study is for
- Premature Ovarian Failure
- What is being tested?
- Goserelin and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 1 Nov 2024
- Phase
- Phase 2
- 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 17 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female lymphoma patients will be included in the study if they meet the following criteria:
- Confirmed lymphoma cancer radiological and pathological or by clinical evaluation receiving chemotherapy treatment
- Normal FSH-level , estradiol level (FSH levels less than 10IU/L at the time of random assignment)
- Female Age between 17- 40 years
- Written informed consent
Who cannot join
- The patients will be excluded from the study if they have the following criteria:
- Known hypersensitivity reaction to the investigational compounds or incorporated substances
- Primary ovarian dysfunction, previous history of amenorrhea >3 months
- Age > 40
- Pregnant or lactating patients, prior use of hormonal contraceptives has to be discontinued before first Goserelin injection
- patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism, Vaginitis, vaginal bleeding, cardiac arrhythmia)
Trial locations and contacts
1 site in 1 country.
About this study
To Prevent Chemotherapy Induced Ovarian Failure with the gonadotropin-releasing hormone Agonist Goserelin in Young female Lymphoma Cancer patients Receiving Chemotherapy
Read the detailed description
Design:
Study will be prospective interventional simple randomized control parallel open label Arms and Interventions Arm 1: Goserelin plus standard chemotherapy Goserelin will be given as a 3.6 mg subcutaneous injection in the abdominal wall every 4 weeks (28 ± 3 days) plus standard chemotherapy at start of regimen for 3 months (26) Arm 2 (control Arm): Standard chemotherapy Patients will take only standard chemotherapy for 3 months Setting: oncology department Beni Suef university hospital Sample size: 80 patients (based on the results from the literature and to ensure a power of 80% and a type I error probability of 5%. we calculate Effect size Primary Outcome Measures
Evaluating ovarian function by: at the start of treatment and after 3 cycles chemotherapy treatment and at end of 6 cycles chemotherapy through:
- FSH level (follicle-stimulating hormone (FSH))
- Estradiol level
- AMH level follow up time time frame 1 year follow up after chemotherapy
Secondary Outcome Measures:
- Overall All Response determined by tumor assessments from radiological tests including one of the following (computed tomography scan, Magnetic resonance imaging Positron-emission tomography or physical examinations according RECIL 2017 criteria.
- Adverse events (Sweating, Hot flushes, vaginal bleeding, vaginal dryness. Headaches)
- Conditions
- Premature Ovarian Failure
- Being tested
- Goserelin, Chemotherapy
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoserelinDrug
Also called zoladex
chemotherapy+goserelin
ChemotherapyDrug
Also called chemotherapy protocols
standard chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Goserelin arm | Other | 3.6 mg subcutaneous injection in the abdominal wall every 4 weeks (28 ± 3 days) plus standard chemotherapy at start of regimen for 3 months Receives: Drug: Goserelin |
| control Arm | Other | Standard chemotherapy Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention premature ovarian failure
Evaluating ovarian function by FSH,E2 levels
Measured: 6 month from start of chemotherapy
Secondary outcomes (2)
overall response in lymphoma patients
Overall response rate determined by tumor assessments from radiological tests including one of the following (computed tomography scan, Magnetic resonance imaging Positron-emission tomography or physical examinations , ( RECIL 2017) The overall response evaluation criteria in lymphoma, criteria categorized patients stable disease,progressive disease ,minor response,partial response,complete response at end of 6 months.
Measured: 6 month
ADVERSE EFFECTS
Adverse events (Sweating, Hot flushes, vaginal bleeding, vaginal dryness. Headaches)
Measured: 6 MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start1 Mar 2019
- Primary completion1 Dec 2020
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian FailureStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: Goserelin plus standard chemotherapy Arm 2 (control Arm): Standard chemotherapy
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALshaimaa Ibrahim Rabie, Beni-Suef University
- Investigators
- Ahmed Abdullah Elberry Elberry, MD, Study director, Assistant Professor of Clinical Pharmacology, Beni-Suef UniversityRaghda Roshdy Sayed Hussein, MD, Study director, Lecturer of Clinical pharmacy, Beni-Suef Universityahmed hassan shaaban, Study director, Lecturer of Clinical Oncology, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536467
- Sponsor's protocol ID
- FWA 00015574
- Status last verified
- Mar 2024
- First submitted
- 27 Aug 2020
- Last updated
- 19 Mar 2024
- 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 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Chemotherapy-Induced Ovarian Failure With Goserelin in Premenopausal Lymphoma Patients
- ClinicalTrials.gov ID
- NCT04536467
- Acronym / sponsor ID
- FWA 00015574
- Conditions
- Premature Ovarian Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 2 Sep 2020 (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.
To Prevent Chemotherapy Induced Ovarian Failure with the gonadotropin-releasing hormone Agonist Goserelin in Young female Lymphoma Cancer patients Receiving Chemotherapy
Detailed description
Design:
Study will be prospective interventional simple randomized control parallel open label Arms and Interventions Arm 1: Goserelin plus standard chemotherapy Goserelin will be given as a 3.6 mg subcutaneous injection in the abdominal wall every 4 weeks (28 ± 3 days) plus standard chemotherapy at start of regimen for 3 months (26) Arm 2 (control Arm): Standard chemotherapy Patients will take only standard chemotherapy for 3 months Setting: oncology department Beni Suef university hospital Sample size: 80 patients (based on the results from the literature and to ensure a power of 80% and a type I error probability of 5%. we calculate Effect size Primary Outcome Measures
Evaluating ovarian function by: at the start of treatment and after 3 cycles chemotherapy treatment and at end of 6 cycles chemotherapy through:
- FSH level (follicle-stimulating hormone (FSH))
- Estradiol level
- AMH level follow up time time frame 1 year follow up after chemotherapy
Secondary Outcome Measures:
- Overall All Response determined by tumor assessments from radiological tests including one of the following (computed tomography scan, Magnetic resonance imaging Positron-emission tomography or physical examinations according RECIL 2017 criteria.
- Adverse events (Sweating, Hot flushes, vaginal bleeding, vaginal dryness. Headaches)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm 1: Goserelin plus standard chemotherapy Arm 2 (control Arm): Standard chemotherapy
| Arm | Type | Receives |
|---|---|---|
| Goserelin arm | Other | Drug: Goserelin3.6 mg subcutaneous injection in the abdominal wall every 4 weeks (28 ± 3 days) plus standard chemotherapy at start of regimen for 3 months |
| control Arm | Other | Drug: ChemotherapyStandard chemotherapy |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Female lymphoma patients will be included in the study if they meet the following criteria:
- Confirmed lymphoma cancer radiological and pathological or by clinical evaluation receiving chemotherapy treatment
- Normal FSH-level , estradiol level (FSH levels less than 10IU/L at the time of random assignment)
- Female Age between 17- 40 years
- Written informed consent
Key exclusion criteria (6 listed)
- Known hypersensitivity reaction to the investigational compounds or incorporated substances
- Primary ovarian dysfunction, previous history of amenorrhea >3 months
- Age > 40
- Pregnant or lactating patients, prior use of hormonal contraceptives has to be discontinued before first Goserelin injection
- patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism, Vaginitis, vaginal bleeding, cardiac arrhythmia)
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 |
|---|---|---|
| GoserelinAlso: zoladexchemotherapy+goserelin | Drug | Goserelin arm |
| ChemotherapyAlso: chemotherapy protocolsstandard chemotherapy | Drug | control Arm |
Primary outcome
prevention premature ovarian failure
Time frame: 6 month from start of chemotherapy
Evaluating ovarian function by FSH,E2 levels
2 secondary outcomes
overall response in lymphoma patients
Time frame: 6 month
ADVERSE EFFECTS
Time frame: 6 MONTH
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- 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.
Ahmed Abdullah Elberry Elberry, MD study director
Assistant Professor of Clinical Pharmacology, Beni-Suef University
Raghda Roshdy Sayed Hussein, MD study director
Lecturer of Clinical pharmacy, Beni-Suef University
ahmed hassan shaaban study director
Lecturer of Clinical Oncology, Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Goserelin and Chemotherapy in people with Premature Ovarian Failure, run by Beni-Suef 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 5 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 19 Mar 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevention premature ovarian failure (time frame: 6 month from start of chemotherapy). 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 19 Mar 2024.