Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT02712320
Eligibility Criteria:
Inclusion Criteria:
1. Complete 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001. If a subject wishes to enter the Extension study after more than 28 days following his end of study visit for Protocol FP01C-13-001, his serum testosterone level should be repeated at the screening visit to confirm that his castrate-level testosterone has been maintained.
2. Laboratory values
* Absolute neutrophil count ≥ 1,500 cells/µL
* Platelets≥100,000 cells/µL
* Hemoglobin ≥ 10 gm/dL
* Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
* Aspartate Transaminase (AST/SGOT) ≤ 2.5 × ULN
* Alanine Aminotransferase (ALT/SGPT) ≤ 2.5 × ULN
* Serum creatinine ≤ 1.5 mg/dL
* Lipid profile within acceptable range according to investigator's opinion
* Serum glucose within acceptable range according to investigator's opinion
* HgbA1c within acceptable range according to investigator's opinion
* Clinical chemistries (K, Na, Mg, Ca and P) within acceptable range according to investigator's judgment
* Urinalysis within normal range according to the investigator's judgment
3. Agree to use male contraceptive methods during study trial
4. In the Investigator's opinion, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol
5. All aspects of the protocol explained and written informed consent obtained \*If the patient completed 12 months of treatment with LMIS 50 mg more than 28 days prior to entering the Extension study, the Eastern Cooperative Oncology Group (ECOG), Physical Examination (PE), ECG, laboratory and Prostate Specific Antigen (PSA) tests should be repeated.
If the patient has completed 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001 within the last 28 days, they will be allowed to enter the Extension study without repeating the testosterone measurements, ECG, PE, laboratory and the PSA tests
Exclusion Criteria:
1. Receipt of chemotherapy, immunotherapy, cryotherapy, radiotherapy, or anti-androgen therapy other than LMIS 50 mg under Protocol FP01C-13-001 for treatment of carcinoma of the prostate during the subject's participation in Protocol FP01C-13-001. Radiation for pain control will be allowed during the study.
2. Receipt of any Luteinizing Hormone-releasing Hormone (LHRH) suppressive therapy within 6 months of Screening Visit other than LMIS 50 mg under Protocol FP01C-13-001
3. Subject has used prohibited treatments as listed in the Section 8.2 during participation in Protocol FP01C-13-001.
4. Any pathological event, clinical adverse event, or any change in the subject's status at the end of FP01C-13-001 giving indication to the investigator that further participation in the study may not be the best interest of the subject
5. Investigator considers that it is no longer feasible for the subject to be included in a study of LMIS 50 mg
6. Subjects with persistent, non-castrate testosterone levels judged by the investigator
7. Uncontrolled intercurrent illness that would jeopardize the subject's safety, interfere with the objectives of the protocol, or limit the subject's compliance with study requirements, as determined by the Investigator in consultation with the Sponsor
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02712320
Study Brief:
Protocol Section:
NCT02712320