Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01011751 | Treatment of Hot Flushes Caused by Leuprorelin 11.25 mg in Prostate Adenocarcinoma | PHASE3 | COMPLETED | 311 | — | — | Apr 1, 2004 | Dec 1, 2007 | Jul 30, 2015 | 1 | France |
The change is calculated as follows: \[(HF score at Week 4 of treatment - HF score at randomization)/HF score at randomization\]\*100. The calculation of the HF score will be done as follows: a coefficient is allocated to each severity grade, it varies from 1 to 4 (1: slight; 2: moderate; 3: severe; 4: very severe), and the calculation of the daily score is equal to the sum of the daily instances of hot flushes multiplied by their severity coefficient. The score calculated at randomization and Week 4 of treatment will be the average of the scores recorded in the preceding week. The score range will depend upon the frequency of hot flushes, and higher score signifies higher severity of hot flushes.
| Arm | Type | Description |
|---|---|---|
| Cyproterone acetate | EXPERIMENTAL | Leuprorelin 11.25 mg, injection, subcutaneously at Months 0, 3, and 6, and flutamide 250 mg, tablet, orally, thrice daily for first 30 days from first leuprorelin administration. From Month 6, cyproterone acetate 50 mg, tablet-in-capsule, along with cyproterone acetate placebo-matching capsule, orally, once daily in the morning and cyproterone acetate 50 mg, tablet-in-capsule, orally, once daily in the evening for 8 weeks. Cyproterone acetate placebo-matching capsule, orally, once daily in the morning for the next 2 weeks. |
| Medroxyprogesterone acetate | EXPERIMENTAL | Leuprorelin 11.25 mg, injection, subcutaneously at Months 0, 3, and 6, and flutamide 250 mg, tablet, orally, thrice daily for first 30 days from first leuprorelin administration. From Month 6, medroxyprogesterone acetate 10 mg, tablet-in-capsule, along with medroxyprogesterone acetate placebo-matching capsule, orally, once daily in the morning and medroxyprogesterone acetate 10 mg, tablet-in-capsule, orally, once daily in the evening for 8 weeks. Medroxyprogesterone acetate placebo-matching capsule, orally, once daily in the morning for the next 2 weeks. |
| Venlafaxine | EXPERIMENTAL | Leuprorelin 11.25 mg, injection, subcutaneously at Months 0, 3, and 6, and flutamide 250 mg, tablet, orally, thrice daily for first 30 days from first leuprorelin administration. From Month 6, venlafaxine 75 mg, capsule, orally, once daily in the morning and venlafaxine placebo-matching capsule, orally, once daily in the evening for 8 weeks. Venlafaxine 37.5 mg, capsule, orally, once daily in the evening for the next 2 weeks. |
| Name | Type | Description |
|---|---|---|
| Cyproterone acetate | DRUG | Cyproterone acetate tablet-in-capsule. |
| Medroxyprogesterone acetate | DRUG | Medroxyprogesterone acetate tablet-in-capsule. |
| Venlafaxine | DRUG | Venlafaxine capsule. |
| Leuprorelin | DRUG | Leuprorelin injection. |
| Flutamide | DRUG | Flutamide tablet |
| Placebo | DRUG | Cyproterone acetate, medroxyprogesterone acetate or venlafaxine placebo-matching capsule. |
Inclusion Criteria: - Patient has a histologically proven prostatic adenocarcinoma. * Patient has been on a gonadotropin releasing hormone (GnRH) agonist treatment for a duration of at least 1 year. * Karnofsky index greater than or equal to (\>=) 70 %. * Patient who, after having been clearly info...