Treatment of Hot Flushes Caused by Leuprorelin [amount hidden] in Prostate Adenocarcinoma

What Was Tested

In this phase 3 trial, researchers set out to test Leuprolide.

It had three arms (groups): Cyproterone acetate (experimental), Medroxyprogesterone acetate (experimental) and Venlafaxine (experimental).

The registry classes the interventions as drug.

More on the Plan

Three drugs will be tested in this study: cyproterone acetate, medroxyprogesterone acetate and venlafaxine.

Cyproterone acetate, medroxyprogesterone acetate and venlafaxine are being tested to treat men who suffer from hot flushes due to androgen suppression treatment for prostate cancer.

This study will look at the frequency and severity of hot flushes caused by leuprorelin in participants who will take cyproterone acetate, medroxyprogesterone acetate or venlafaxine.

The study will randomize approximately 311 participants.

Who Took Part

Enrollment: 311 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patient has been on a gonadotropin releasing hormone (GnRH) agonist treatment for a duration of at least 1 year. Patient who, after having been clearly informed, has given his written consent to participate in the study.

The full record lists 3 inclusion and 14 exclusion criteria; among the exclusions: patient included in a therapeutic trial in the 3 months preceding the inclusion visit; prescription of agonist planned in the context of neo-adjuvant hormonotherapy; patient has symptomatic bone metastases.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Leuprolide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2004-04 with completion listed for 2007-12.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent Change from Randomization in Hot Flushes (HF) Score at Week 4 of Treatment (time frame: Randomization (Month 6) and Week 4 of treatment (Month 7)).

It also tracked 11 secondary outcomes, for example Percent Change from Randomization in HF Frequency at Weeks 4, 8 of Treatment and Last Available Value, Percentage of Participants with Complete Regression of hot flushes, Percent Change in HF Score from Randomization at Week 8 of Treatment and Last Available Value, Percent Change from Week 4 of treatment in HF Score at Week 8 of Treatment, Percent Change from Week 4 of treatment in HF Frequency at Week 8 of Treatment and Percentage of Participants Who Wish to Continue the Treatment at the End of Week 10.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 311 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.