AzTrials
AzTrials

Prostate Cancer MetastaticPhase 2NCT03646162

Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer

A Phase 2 study testing Veru-944 in people with Prostate Cancer Metastatic, run by Veru Inc. at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Randomized, double-blind, placebo controlled, dose finding Phase 2 study comparing oral daily dosing of VERU-944 after a week of loading (daily dosing) with placebo to ameliorate the vasomotor symptoms resulting from androgen deprivation therapy in men with advanced prostate cancer Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer Metastatic
What is being tested?
Veru-944
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
93 participants
Where
24 sitesUnited States
Study dates
14 Sep 2018to 15 Oct 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 16Show fewer
  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Urologic Consultants

    Bala-Cynwyd, Pennsylvania, 19004

  • Coastal Urology

    Brick, New Jersey, 08724

  • North Idaho Urology

    Coeur d'Alene, Idaho, 83814

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

  • Urology Clinics of North Texas

    Dallas, Texas, 75231

  • The Urology Center of Colorado

    Denver, Colorado, 80211

  • Universal Axon Clinical Research

    Doral, Florida, 33166

  • Premier Urology Group

    Edison, New Jersey, 08837

  • Advance Urology

    Elmont, New York, 11003

  • AccuMed Research

    Garden City, New York, 11530

  • Gen1 Research

    Glendale, Arizona, 85308

  • Foothills Urology

    Golden, Colorado, 80401

  • Houston Urology Partners

    Houston, Texas, 77091

  • First Urology

    Jeffersonville, Indiana, 47130

  • Tower Urology

    Los Angeles, California, 90048

  • Medical Research Center

    Miami, Florida, 33144

  • Clinical Research Solutions

    Middleburg Heights, Ohio, 44130

  • Premier Medical Group of the Hudson Valley

    Poughkeepsie, New York, 12601

  • Urology San Antonio

    San Antonio, Texas, 78229

  • Urology of San Bernardino

    San Bernardino, California, 92404

  • Regional Urology LLC

    Shreveport, Louisiana, 71101

  • Associated Medical Professionals

    Syracuse, New York, 13210

  • Chesapeake Urology

    Towson, Maryland, 21204

  • Urology of Virginia

    Virginia Beach, Virginia, 23462

Other trials in United States

About this study

Official title: Randomized, Double-blind, Placebo Controlled, Dose Finding Phase 2 Study Comparing Oral Daily Dosing of VERU-944 to Ameliorate the Vasomotor Symptoms Resulting From ADT in Men With Advanced Prostate Cancer

Randomized, double-blind, placebo controlled, dose finding Phase 2 study comparing oral daily dosing of VERU-944 after a week of loading (daily dosing) with placebo to ameliorate the vasomotor symptoms resulting from androgen deprivation therapy in men with advanced prostate cancer

Read the detailed description

This study is a multicenter, randomized, double-blind, placebo controlled, dose finding study of VERU-944 to treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT. The study will have four arms with 30 subjects per arm. The subjects participating in the study will have advanced prostate cancer and will be undergoing androgen deprivation therapy (ADT) with a luteinizing hormone releasing hormone (LHRH) therapy (agonist or antagonist) for at least the three months prior to randomization and be experiencing regular moderate to severe hot flashes while on ADT. Subjects will all continue to receive ADT and will be randomized to receive, for the first four days, a loading dose followed by daily doses of placebo or VERU-944 (10 mg, 50 mg or 100 mg) orally for a total period of 12 weeks.

Being tested
Veru-944, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Veru-944Drug

    Also called Zuclomiphene citrate

    Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT

  • PlaceboDrug

    Placebo

Study groups in NCT03646162
Study groupRoleWhat they receive
Veru-944 10 mgExperimentalVeru-944 10 mg daily
Receives: Drug: Veru-944
Veru-944 50 mgExperimentalVeru-944 50 mg daily
Receives: Drug: Veru-944
PlaceboPlacebo comparatorPlacebo daily
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Frequency of Moderate to Severe Hot Flashes at 6 Weeks

    Percentage of change in frequency of moderate to severe hot flashes at 6 weeks

    Measured: 6 weeks

Secondary outcomes (5)

  1. Percentage Change in Severity of Moderate to Severe Hot Flashes at 6 Weeks

    Change in severity of moderate to severe hot flashes compared to baseline at 6 weeks

    Measured: 6 weeks

  2. Change of Frequency of Moderate to Severe Hot Flashes at Week 12

    Mean change in frequency of moderate to severe hot flashes compared to baseline at weeks 12

    Measured: Weeks 12

  3. Change in Severity of Moderate to Severe Hot Flashes at Week 12

    Mean change in severity of moderate to severe hot flashes compared to baseline at week 12

    Measured: Week 12

  4. Change in Bone Turnover Markers C-telopeptide (CTX)

    Change in C-telopeptide concentration at day 84 compared to baseline

    Measured: 84 days

  5. Change in Bone Turnover Markers Alkaline Phosphatase

    Change in bone specific alkaline phosphatase at day 84 compared to baseline

    Measured: 84 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2018
  2. Study start14 Sep 2018
  3. Primary completion30 Apr 2020
  4. Study completion15 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03646162
Sponsor's protocol ID
V72203
Status last verified
Dec 2021
First submitted
17 Aug 2018
Last updated
3 Dec 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Veru-944 in people with Prostate Cancer Metastatic, run by Veru Inc. at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Frequency of Moderate to Severe Hot Flashes at 6 Weeks (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03646162.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in