Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria

Be over 18 years of age;
Be able to communicate effectively with the study personnel;
Have histologically confirmed prostate cancer;
Have been treated with an LHRH agonist or LHRH antagonist for at least the 3 months prior to randomization;
Be continued on an LHRH agonist or LHRH antagonist throughout this study;
Have experienced hot flashes for at least one month prior to study entry;
Have moderate or severe vasomotor symptoms (hot flashes) (defined as a minimum of 4 moderate to severe hot flashes per day or 12 per week at baseline);
ECOG performance status of 0 to 2

Be willing to uses electronic data capture for the relevant medical events

• Must be at least 80% compliant during the screening period

Subjects must agree to use acceptable methods of contraception:

If their female partners are pregnant or lactating, acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication must be used. Acceptable methods are: Condom used with spermicidal foam/gel/film/cream/suppository. If the subject has undergone surgical sterilization (vasectomy with documentation of azospermia), a condom with spermicidal foam/gel/film/cream/suppository should be used.
If the male subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/film/cream/suppository [i.e., barrier method of contraception], surgical sterilization (vasectomy with documentation of azospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository).
If the female partner has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used.
If the female partner has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used.
Subject is willing to comply with the requirements of the protocol through the end of the study.

Exclusion Criteria

Have a serum total testosterone concentration > 50 ng/dL at screening;
Known hypersensitivity or allergy to estrogen or estrogen like drugs;
Any disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk;
Subjects with a personal history of abnormal blood clotting or thrombotic disease, including venous or arterial thrombotic events such as a history of stroke, deep vein thrombosis (DVT), and/or pulmonary embolus (PE);

Any subjects, as determined by a central laboratory, that have a:

Factor V Leiden gene mutation
Prothrombin gene mutation
Uncontrolled symptomatic congestive heart failure (NYHA Class III - IV), unstable angina pectoris, cardiac arrhythmia, or uncontrolled atrial fibrillation;
History of MI
The presence of consistently abnormal laboratory values which are considered clinically significant. In addition, any subject with liver enzymes (ALT or AST) above 2 times the upper limit of normal, total bilirubin above 2 times the upper limit of normal, or serum creatinine above 1.5 times the upper limit of normal will NOT be admitted to the study;
Received an investigational drug within a period of 90 days prior to enrollment in the study;
Received the study medication (VERU-944) previously;
Have previously taken within 6 months prior to screening or are currently taking diethylstilbestrol, other estrogens;
Currently taking gabapentin, estrogen, diethylstilbestrol, medroxyprogesterone acetate, clomiphene, selective serotonin reuptake inhibitors (SSRIs), other treatments for hot flashes
Recent hospitalization for more than 24 hours (within 30 days of screening);
Recent surgery (within 30 days of screening);
Have been previously diagnosed or treated for active cancer (other than prostate cancer or non-melanoma skin cancer) within the previous five years;
Have a BMI >40.