Leuprorelin

PBAC score was used to measure volume of menstrual blood loss. Participants used sanitary products designated by sponsor and recorded the numbers of tampons or towels used, clots and flooding in patient diary. Three diagrams used which represented a lightly, moderately stained or completely saturated pad/tampon. Following scores assigned: 1) 1, 5, or 20 points for each pad; 2) 1, 5, or 10 points for each tampon; 3) 1 or 5 points for each blood clot of \<1 cm/=1 cm/\>1 in longest diameter; 4) 5 points for each episode of flooding. The total PBAC score (sum of points) ranges from 0 to \>500.

Staging biopsy of at least 12 cores were sampled and analyzed according to a centralized biopsy procedure which confirm the results of the first biopsy \[presence of positive cores, the absence of core with tumor length \> 3 millimeters (mm), and absence Grade 4 cells (Gleason score \< 7)\]. The Gleason score grades prostate cancer tissue, based on its appearance under a microscope. Scores range from 2 to 10, with a higher score meaning that the cancer tissue is more likely to spread.

PFS=time from randomization to first documentation of progression (death, biological progression or clinical progression). PFS at Year 5=probability of participants' PFS at Year 5. Biological progression definition I: halfway point between nadir and first rise with prostate-specific antigen (PSA) ≥1 nanogram per milliliter (ng/mL) signifying progression and date of introduction of prostate treatment for all participants, including those leaving prematurely for reason other than progression/death; definition II: first date when PSA=nadir+2 ng/mL and date of introduction of prostate treatment, for participants leaving prematurely for reason other than progression/death. Clinical progression: local clinical progression-\>50% increase in prostate volume relative to lowest volume, recurrence of palpable prostatic tumor after complete regression, positive biopsy; locoregional progression=pelvic regional lymph node lesion development; metastatic progression=distant lesions identification.

Median Overall survival is defined as the number of days from date of inclusion to the date of death. For subjects who do not die, survival will be censored at the date of last contact.

Median Progression Free Survival=time from date of inclusion to date of first documentation of progressive disease (death, biological progression, clinical progression). Biological progression: date of the first PSA increase after the nadir and greater than or equal to (≥) 4 ng/mL under treatment. Clinical progression: date of appearance of the clinical sign of progression under treatment. Clinical signs of progression are: 1. Appearance of marked increase of bone pain or appearance of symptoms related to disease progression (example: liver, lungs, kidneys); 2. Alteration of general health conditions related to disease progression (decrease of at least 2 degrees in the European Organization for Research and Treatment of Cancer (ECOG) performance status, weight loss of more than 10% since the last visit); 3. Anemia - drop in hemoglobin level of more than 2 gram per deciliter (g/dL) since the last visit (only if disease related).