Prevention of Chemotherapy-Induced Ovarian Failure With Goserelin in Premenopausal Lymphoma Patients

FWA 00015574

To Prevent Chemotherapy Induced Ovarian Failure with the gonadotropin-releasing hormone Agonist Goserelin in Young female Lymphoma Cancer patients Receiving Chemotherapy

2019-03-01

2020-12-01

2024-11-01

Early phase I

80

Inclusion Criteria: Female lymphoma patients will be included in the study if they meet the following criteria: 1. Confirmed lymphoma cancer radiological and pathological or by clinical evaluation receiving chemotherapy treatment 2. Normal FSH-level , estradiol level (FSH levels less than 10IU/L at the time of random assignment) 3. Female Age between 17- 40 years 4. Written informed consent Exclusion criteria: The patients will be excluded from the study if they have the following criteria: 1. Known hypersensitivity reaction to the investigational compounds or incorporated substances 2. Primary ovarian dysfunction, previous history of amenorrhea \>3 months 3. Age \> 40 4. Pregnant or lactating patients, prior use of hormonal contraceptives has to be discontinued before first Goserelin injection 5. patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism, Vaginitis, vaginal bleeding, cardiac arrhythmia)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Arm 1: Goserelin plus standard chemotherapy Arm 2 (control Arm): Standard chemotherapy', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

2024-03-19