Study of the Effect of GTx-758 on Serum PSA and Testosterone in Men With Prostate Cancer
Study Details
Study Description
Brief Summary
Protocol G200712 is a Phase II, exploratory study to assess the effects of GTx-758 on serum prostate specific antigen (PSA) response ans serum PSA progression in men with Metastatic Castration Resistant Prostate Cancer (mCRPC) on Androgen Deprivation Therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, or orchidectomy. This study will also assess the venous thromboembolism (VTE) risk of lower doses of GTx-758.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GTx-758 125mg one GTx-758 tablet orally administered daily |
Drug: GTx-758 125 mg
One 125 mg tablet once a day
|
| Experimental: GTx-758 250 mg two GTx-758 tablets orally administered daily |
Drug: GTx-758 250 mg
two 125 mg tablets once daily
|
Outcome Measures
Primary Outcome Measures
- Decline in Serum PSA [120 days]
The percentage of subjects with a 50% decline from baseline in serum PSA (confirmed by a second serum PSA assessment 30 days later) by Day 90 (with follow up confirmation by Day 120)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Be over age 18 years
-
Be able to Communicate effectively with the study personnel
-
Have histologically confirmed prostate cancer
-
Have castration resistant prostate cancer patients with radiographic evidence of metastatic disease (T any - N any - MI)
-
ECOG performance status of 0 to 2
-
Have been treated with ADT (chemical or surgical) for at least 6 months
-
Have a castrate level of serum total testosterone (< 50ng/dL)
-
Have a history of serum PSA response on ADT. A serum PSA response is an undetectable level of serum PSA (≤ 0.2/mL) or at least a 90% reduction in serum PSA from the serum PSA value prior to the initiation of treatment to < 10ng/mL
-
Have a rising serum PSA on two successive assessments at least 2 weeks apart and serum PSA levels ≥ 2ng/mL or > 2 ng/mL and a 25% increase above the nadir from the ADT.
-
Be continued on ADT throughout this study
-
give written informed consent prior to any study specific procedures
-
subjects must agree, if not already on anticoagulation therapy or aspirin, to take 81 mg aspirin daily throughout the duration of their participation in this study and for 30 days after completion of dosing with GTx-758.
-
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 3 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 3 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/fil/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 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.
Exclusion Criteria:
-
Known hypersensitivity or allergy to estrogen or estrogen like drugs
-
Need for urgent chemotherapy, radiation therapy or surgical intervention for prostate cancer in the opinion of the investigator;
-
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 (venous or arterial thrombotic events such as history of stroke, deep vein thrombosis (DVT), and or pulmonary embolus (PE)).
-
Any subjects, as determined by a central laboratory, with
-
a modified activated protein C reaction ratio ≤ 2.5 and a Factor V Leiden gene mutation,
-
an antithrombin level below the lower limit of the normal range,
-
an antiphospholipid antibody level that is indeterminate, positive, or outside the normal range,
-
or a prothrombin gene mutation
-
Symptomatic congestive heart failure (NYHA Class III - IV), unstable angina pectoris, cardiac arrhythmia, or history of atrial fibrillation
-
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 the enrollment in the study.
-
Received the study medication GTx-758 previously;
-
Currently taking testosterone, testosterone like agents, 5a-reductase inhibitor (finasteride, dutasteride),or antiandrogens (bicalutamide, flutamide or nilutamide). Subjects taking a 5a-reductase inhibitor or one of these antiandrogens may be eligible if the subject undergoes a 6 week washout period after stopping therapy. The subject must have at least two rising serum PSA levels at least 2 weeks apart after therapy with these 5a-reductase inhibitor or these antiandrogens have been stopped (antiandrogen withdrawal)and complete the 6-week washout period to be eligible;
-
Have previously taken or are currently taking diethylstilbestrol, other estrogens, abiraterone or ketoconazole or any other inhibitor of CYP17 (17a-hydroxylase/C17,20-lyase);
-
Currently having radiation therapy to prostate for cancer control (radiation to bone to relieve pain is acceptable)
-
Have previously taken or are currently taking enzalutamide;
-
Have previously received cytotoxic chemotherapy for prostate cancer;
-
Recent hospitalization (within 30 days of screening);
-
Recent surgery (within 30 days of screening);
-
Have taken body building or fertility supplements within 4 weeks of admission into the study;
-
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 > 35.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Urology Associates Medical Group | Burbank | California | United States | 91505 |
| 2 | VA of Greater Los Angeles | Los Angeles | California | United States | 90073 |
| 3 | Tower Urology | Los Angeles | California | United States | 90078 |
| 4 | San Bernardino Urological Assoc. | San Bernardino | California | United States | 92404 |
| 5 | Genesis Healthcare Partners | San Diego | California | United States | 92123 |
| 6 | Urology Specialists of So. California | Torrance | California | United States | 90505 |
| 7 | Univ. of Colorado Cancer Center | Aurora | Colorado | United States | 80045 |
| 8 | Connecticut Clinical Research Center | Middlebury | Connecticut | United States | 06762 |
| 9 | So. Florida Medical Research | Aventura | Florida | United States | 33180 |
| 10 | AMPM Research | Miami | Florida | United States | 33145 |
| 11 | GTx Investigative Site | Saint Petersburg | Florida | United States | 33710 |
| 12 | Pinellas Urology | Saint Petersburg | Florida | United States | 33710 |
| 13 | Coastal Medical Center | Sarasota | Florida | United States | 34237 |
| 14 | Urology of Indiana | Greenwood | Indiana | United States | 46143 |
| 15 | First Urology PSC | Jeffersonville | Indiana | United States | 47130 |
| 16 | Chesapeake Urology Research Assoc. | Towson | Maryland | United States | 21204 |
| 17 | Five Valleys Urology | Missoula | Montana | United States | 59808 |
| 18 | Urological Institute of NE New York | Albany | New York | United States | 12208 |
| 19 | AMP of NY | Oneida | New York | United States | 13421 |
| 20 | AMP of NY | Syracuse | New York | United States | 13210 |
| 21 | Carolina Clinical Trials | Concord | North Carolina | United States | 28025 |
| 22 | The Urology Group | Cincinnati | Ohio | United States | 45212 |
| 23 | UCSEPA | Bala-Cynwyd | Pennsylvania | United States | 19004 |
| 24 | West Clinic | Memphis | Tennessee | United States | 38119 |
| 25 | Urology of Virginia | Virginia Beach | Virginia | United States | 23462 |
| 26 | Seattle Cancer Care Alliance, Univ. of Washington | Seattle | Washington | United States | 98195 |
Sponsors and Collaborators
- GTx
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- G200712
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | GTx-758 125mg | GTx-758 250 mg |
|---|---|---|
| Arm/Group Description | one GTx-758 tablet orally administered daily GTx-758 125 mg: One 125 mg tablet once a day | two GTx-758 tablets orally administered daily GTx-758 250 mg: two 125 mg tablets once daily |
| Period Title: Overall Study | ||
| STARTED | 38 | 39 |
| COMPLETED | 23 | 19 |
| NOT COMPLETED | 15 | 20 |
Baseline Characteristics
| Arm/Group Title | GTx-758 125mg | GTx-758 250 mg | Total |
|---|---|---|---|
| Arm/Group Description | one GTx-758 tablet orally administered daily GTx-758 125 mg: One 125 mg tablet once a day | two GTx-758 tablets orally administered daily GTx-758 250 mg: two 125 mg tablets once daily | Total of all reporting groups |
| Overall Participants | 38 | 39 | 77 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
71
|
69
|
70
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
0
0%
|
0
0%
|
| Male |
38
100%
|
39
100%
|
77
100%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
5
13.2%
|
5
12.8%
|
10
13%
|
| White |
33
86.8%
|
34
87.2%
|
67
87%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
33
86.8%
|
21
53.8%
|
54
70.1%
|
| Hungary |
5
13.2%
|
18
46.2%
|
23
29.9%
|
Outcome Measures
| Title | Decline in Serum PSA |
|---|---|
| Description | The percentage of subjects with a 50% decline from baseline in serum PSA (confirmed by a second serum PSA assessment 30 days later) by Day 90 (with follow up confirmation by Day 120) |
| Time Frame | 120 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | GTx-758 125mg | GTx-758 250 mg |
|---|---|---|
| Arm/Group Description | one GTx-758 tablet orally administered daily GTx-758 125 mg: One 125 mg tablet once a day | two GTx-758 tablets orally administered daily GTx-758 250 mg: two 125 mg tablets once daily |
| Measure Participants | 38 | 39 |
| Number [participants] |
4
10.5%
|
10
25.6%
|
Adverse Events
| Time Frame | From time of screening to end of study, up to 4 years | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | GTx-758 125mg | GTx-758 250 mg | ||
| Arm/Group Description | one GTx-758 tablet orally administered daily GTx-758 125 mg: One 125 mg tablet once a day | two GTx-758 tablets orally administered daily GTx-758 250 mg: two 125 mg tablets once daily | ||
All Cause Mortality |
||||
| GTx-758 125mg | GTx-758 250 mg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/38 (2.6%) | 1/39 (2.6%) | ||
Serious Adverse Events |
||||
| GTx-758 125mg | GTx-758 250 mg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/38 (2.6%) | 10/39 (25.6%) | ||
| Cardiac disorders | ||||
| pulmonary embolism | 0/38 (0%) | 3/39 (7.7%) | ||
| acute myocardial infarction | 0/38 (0%) | 3/39 (7.7%) | ||
| venous thrombosis | 0/38 (0%) | 3/39 (7.7%) | ||
| pulmonary artery stenosis | 0/38 (0%) | 5/39 (12.8%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| paraplegia | 0/38 (0%) | 5/39 (12.8%) | ||
| Renal and urinary disorders | ||||
| Acute pyelonephritis | 1/38 (2.6%) | 0/39 (0%) | ||
| Urinary Tract Infection | 1/38 (2.6%) | 0/39 (0%) | ||
| acute renal failure | 1/38 (2.6%) | 5/39 (12.8%) | ||
| dehydration | 0/38 (0%) | 5/39 (12.8%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| pneumonia | 1/38 (2.6%) | 0/39 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| GTx-758 125mg | GTx-758 250 mg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 31/38 (81.6%) | 33/39 (84.6%) | ||
| Blood and lymphatic system disorders | ||||
| anemia | 3/38 (7.9%) | 3/39 (7.7%) | ||
| bruising | 1/38 (2.6%) | 0/39 (0%) | ||
| leukocytosis | 0/38 (0%) | 1/39 (2.6%) | ||
| lymph node calcification | 1/38 (2.6%) | 0/39 (0%) | ||
| Cardiac disorders | ||||
| acute coronary syndrome | 0/38 (0%) | 1/39 (2.6%) | ||
| angina | 2/38 (5.3%) | 1/39 (2.6%) | ||
| AV block, first degree | 2/38 (5.3%) | 1/39 (2.6%) | ||
| bradycardia | 1/38 (2.6%) | 0/39 (0%) | ||
| bundle branch block, right | 0/38 (0%) | 1/39 (2.6%) | ||
| cardiac aneurysm | 1/38 (2.6%) | 0/39 (0%) | ||
| congestive heart failure | 1/38 (2.6%) | 0/39 (0%) | ||
| cardiomegaly | 1/38 (2.6%) | 0/39 (0%) | ||
| coronary artery disease | 3/38 (7.9%) | 2/39 (5.1%) | ||
| left ventricular hypertrophy | 1/38 (2.6%) | 0/39 (0%) | ||
| myocardial infarction | 1/38 (2.6%) | 0/39 (0%) | ||
| ventricular extrasystoles | 1/38 (2.6%) | 0/39 (0%) | ||
| Congenital, familial and genetic disorders | ||||
| adenomatous polyposis coli | 0/38 (0%) | 1/39 (2.6%) | ||
| asplenia | 0/38 (0%) | 1/39 (2.6%) | ||
| Ear and labyrinth disorders | ||||
| deafness, bilateral | 0/38 (0%) | 1/39 (2.6%) | ||
| deafness, neurosensory | 0/38 (0%) | 1/39 (2.6%) | ||
| tinnitus | 1/38 (2.6%) | 2/39 (5.1%) | ||
| vertigo | 1/38 (2.6%) | 0/39 (0%) | ||
| Endocrine disorders | ||||
| adrenal mass | 1/38 (2.6%) | 0/39 (0%) | ||
| goiter | 0/38 (0%) | 1/39 (2.6%) | ||
| hyperthyroidism | 0/38 (0%) | 2/39 (5.1%) | ||
| hypogonadism | 0/38 (0%) | 1/39 (2.6%) | ||
| hypothyroidism | 4/38 (10.5%) | 1/39 (2.6%) | ||
| Eye disorders | ||||
| cataracts | 1/38 (2.6%) | 1/39 (2.6%) | ||
| glaucoma | 2/38 (5.3%) | 3/39 (7.7%) | ||
| lacrimation increased | 1/38 (2.6%) | 0/39 (0%) | ||
| visual impairment | 1/38 (2.6%) | 0/39 (0%) | ||
| strabismus | 0/38 (0%) | 1/39 (2.6%) | ||
| Gastrointestinal disorders | ||||
| abdominal discomfort | 0/38 (0%) | 1/39 (2.6%) | ||
| abdominal hernia | 1/38 (2.6%) | 0/39 (0%) | ||
| abdominal pain | 2/38 (5.3%) | 0/39 (0%) | ||
| anal fissure | 1/38 (2.6%) | 0/39 (0%) | ||
| barrett's oesophagus | 1/38 (2.6%) | 0/39 (0%) | ||
| constipation | 6/38 (15.8%) | 0/39 (0%) | ||
| diverticulum | 2/38 (5.3%) | 1/39 (2.6%) | ||
| dysphagia | 1/38 (2.6%) | 0/39 (0%) | ||
| gastric ulcer | 1/38 (2.6%) | 0/39 (0%) | ||
| gastroesophageal reflux | 8/38 (21.1%) | 8/39 (20.5%) | ||
| haematochezia | 0/38 (0%) | 1/39 (2.6%) | ||
| hemorrhoids | 1/38 (2.6%) | 2/39 (5.1%) | ||
| hiatus hernia | 1/38 (2.6%) | 0/39 (0%) | ||
| inguinal hernia | 4/38 (10.5%) | 0/39 (0%) | ||
| intestinal cyst | 1/38 (2.6%) | 0/39 (0%) | ||
| irritable bowl syndrome | 0/38 (0%) | 29/39 (74.4%) | ||
| large intestine polyp | 0/38 (0%) | 1/39 (2.6%) | ||
| nausea | 2/38 (5.3%) | 0/39 (0%) | ||
| peptic ulcer | 0/38 (0%) | 1/39 (2.6%) | ||
| rectal stenosis | 1/38 (2.6%) | 0/39 (0%) | ||
| poor dental condition | 1/38 (2.6%) | 0/39 (0%) | ||
| vomiting | 1/38 (2.6%) | 1/39 (2.6%) | ||
| General disorders | ||||
| asthenia | 0/38 (0%) | 1/39 (2.6%) | ||
| chest pain | 0/38 (0%) | 1/39 (2.6%) | ||
| chills | 0/38 (0%) | 1/39 (2.6%) | ||
| fatigue | 7/38 (18.4%) | 4/39 (10.3%) | ||
| foaming at mouth | 1/38 (2.6%) | 0/39 (0%) | ||
| oedema peripheral | 1/38 (2.6%) | 2/39 (5.1%) | ||
| pain | 1/38 (2.6%) | 1/39 (2.6%) | ||
| polyp | 1/38 (2.6%) | 0/39 (0%) | ||
| xerosis | 0/38 (0%) | 1/39 (2.6%) | ||
| Hepatobiliary disorders | ||||
| cholelelithiasis | 1/38 (2.6%) | 0/39 (0%) | ||
| hepatic cyst | 1/38 (2.6%) | 0/39 (0%) | ||
| hepatic steatosis | 1/38 (2.6%) | 0/39 (0%) | ||
| Immune system disorders | ||||
| allergy to venom | 0/38 (0%) | 1/39 (2.6%) | ||
| drug hypersensitivity | 1/38 (2.6%) | 0/39 (0%) | ||
| seasonal allergy | 3/38 (7.9%) | 1/39 (2.6%) | ||
| Infections and infestations | ||||
| acarodermatitis | 1/38 (2.6%) | 0/39 (0%) | ||
| acute sinusitis | 0/38 (0%) | 1/39 (2.6%) | ||
| cystitis | 0/38 (0%) | 1/39 (2.6%) | ||
| diverticulitis | 2/38 (5.3%) | 0/39 (0%) | ||
| echinococciasis | 0/38 (0%) | 1/39 (2.6%) | ||
| fungal skin infection | 1/38 (2.6%) | 0/39 (0%) | ||
| herpes virus infection | 1/38 (2.6%) | 0/39 (0%) | ||
| herpes zoster | 0/38 (0%) | 1/39 (2.6%) | ||
| labyrinthitis | 0/38 (0%) | 1/39 (2.6%) | ||
| nasopharyngitis | 0/38 (0%) | 1/39 (2.6%) | ||
| sinusitis | 1/38 (2.6%) | 1/39 (2.6%) | ||
| upper respiratory tract infection | 1/38 (2.6%) | 1/39 (2.6%) | ||
| urinary tract infection | 2/38 (5.3%) | 2/39 (5.1%) | ||
| Injury, poisoning and procedural complications | ||||
| ankle fracture | 0/38 (0%) | 1/39 (2.6%) | ||
| back injury | 1/38 (2.6%) | 0/39 (0%) | ||
| clavicle fracture | 1/38 (2.6%) | 0/39 (0%) | ||
| facial bones fracture | 1/38 (2.6%) | 0/39 (0%) | ||
| forearm fracture | 0/38 (0%) | 1/39 (2.6%) | ||
| hip fracture | 1/38 (2.6%) | 0/39 (0%) | ||
| humerus fracture | 2/38 (5.3%) | 1/39 (2.6%) | ||
| infection related reaction | 1/38 (2.6%) | 0/39 (0%) | ||
| jaw fracture | 1/38 (2.6%) | 0/39 (0%) | ||
| joint injury | 1/38 (2.6%) | 0/39 (0%) | ||
| limb injury | 0/38 (0%) | 2/39 (5.1%) | ||
| Lower limb fracture | 0/38 (0%) | 1/39 (2.6%) | ||
| pelvic fracture | 1/38 (2.6%) | 0/39 (0%) | ||
| rib fracture | 1/38 (2.6%) | 1/39 (2.6%) | ||
| road traffic accident | 1/38 (2.6%) | 0/39 (0%) | ||
| skeletal injury | 0/38 (0%) | 1/39 (2.6%) | ||
| spinal compression fracture | 0/38 (0%) | 1/39 (2.6%) | ||
| tendon rupture | 2/38 (5.3%) | 0/39 (0%) | ||
| wrist fracture | 1/38 (2.6%) | 1/39 (2.6%) | ||
| Investigations | ||||
| ARTHROSCOPY | 1/38 (2.6%) | 0/39 (0%) | ||
| BLOOD CREATININE INCREASED | 0/38 (0%) | 1/39 (2.6%) | ||
| BLOOD GLUCOSE INCREASED | 1/38 (2.6%) | 0/39 (0%) | ||
| cardiac murmur | 1/38 (2.6%) | 0/39 (0%) | ||
| COMPUTERISED TOMOGRAM ABNORMAL | 1/38 (2.6%) | 0/39 (0%) | ||
| ELECTROCARDIOGRAM QT PROLONGED | 1/38 (2.6%) | 0/39 (0%) | ||
| GLUCOSE URINE PRESENT | 1/38 (2.6%) | 0/39 (0%) | ||
| HEART RATE IRREGULAR | 1/38 (2.6%) | 0/39 (0%) | ||
| PROSTATE EXAMINATION ABNORMAL | 1/38 (2.6%) | 0/39 (0%) | ||
| URINE KETONE BODY PRESENT | 1/38 (2.6%) | 0/39 (0%) | ||
| VISUAL TRACKING TEST ABNORMAL | 1/38 (2.6%) | 0/39 (0%) | ||
| WEIGHT DECREASED | 1/38 (2.6%) | 0/39 (0%) | ||
| WEIGHT INCREASED | 0/38 (0%) | 2/39 (5.1%) | ||
| Metabolism and nutrition disorders | ||||
| DECREASED APPETITE | 1/38 (2.6%) | 2/39 (5.1%) | ||
| DIABETES MELLITUS | 2/38 (5.3%) | 4/39 (10.3%) | ||
| HYPERCHOLESTEROLAEMIA | 11/38 (28.9%) | 6/39 (15.4%) | ||
| HYPERGLYCAEMIA | 0/38 (0%) | 1/39 (2.6%) | ||
| HYPERLIPIDAEMIA | 5/38 (13.2%) | 5/39 (12.8%) | ||
| HYPOGLYCAEMIA | 1/38 (2.6%) | 0/39 (0%) | ||
| IMPAIRED FASTING GLUCOSE | 0/38 (0%) | 1/39 (2.6%) | ||
| TYPE 2 DIABETES MELLITUS | 5/38 (13.2%) | 4/39 (10.3%) | ||
| VITAMIN B12 DEFICIENCY | 1/38 (2.6%) | 0/39 (0%) | ||
| VITAMIN D DEFICIENCY | 1/38 (2.6%) | 3/39 (7.7%) | ||
| BACK PAIN | 6/38 (15.8%) | 5/39 (12.8%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| ARTHRALGIA | 3/38 (7.9%) | 4/39 (10.3%) | ||
| ARTHRITIS | 7/38 (18.4%) | 4/39 (10.3%) | ||
| BONE PAIN | 1/38 (2.6%) | 1/39 (2.6%) | ||
| BURSITIS | 1/38 (2.6%) | 0/39 (0%) | ||
| EXOSTOSIS | 0/38 (0%) | 1/39 (2.6%) | ||
| GROIN PAIN | 0/38 (0%) | 1/39 (2.6%) | ||
| INTERVERTEBRAL DISC DEGENERATION | 1/38 (2.6%) | 2/39 (5.1%) | ||
| INTERVERTEBRAL DISC DISORDER | 0/38 (0%) | 1/39 (2.6%) | ||
| JOINT RANGE OF MOTION DECREASED | 1/38 (2.6%) | 0/39 (0%) | ||
| JOINT SWELLING | 1/38 (2.6%) | 0/39 (0%) | ||
| JUVENILE IDIOPATHIC ARTHRITIS | 1/38 (2.6%) | 0/39 (0%) | ||
| KYPHOSCOLIOSIS | 1/38 (2.6%) | 0/39 (0%) | ||
| MOBILITY DECREASED | 1/38 (2.6%) | 0/39 (0%) | ||
| MUSCLE SPASMS | 2/38 (5.3%) | 0/39 (0%) | ||
| MUSCULAR WEAKNESS | 2/38 (5.3%) | 0/39 (0%) | ||
| MUSCULOSKELETAL CHEST PAIN | 1/38 (2.6%) | 1/39 (2.6%) | ||
| MUSCULOSKELETAL PAIN | 0/38 (0%) | 1/39 (2.6%) | ||
| MUSCULOSKELETAL STIFFNESS | 1/38 (2.6%) | 0/39 (0%) | ||
| MYALGIA | 3/38 (7.9%) | 0/39 (0%) | ||
| NECK PAIN | 1/38 (2.6%) | 1/39 (2.6%) | ||
| OSTEITIS DEFORMANS | 1/38 (2.6%) | 1/39 (2.6%) | ||
| OSTEOARTHRITIS | 7/38 (18.4%) | 2/39 (5.1%) | ||
| OSTEOPENIA | 1/38 (2.6%) | 2/39 (5.1%) | ||
| OSTEOPOROSIS | 4/38 (10.5%) | 0/39 (0%) | ||
| OSTEOSCLEROSIS | 1/38 (2.6%) | 0/39 (0%) | ||
| PAIN IN EXTREMITY | 2/38 (5.3%) | 1/39 (2.6%) | ||
| PATHOLOGICAL FRACTURE | 1/38 (2.6%) | 0/39 (0%) | ||
| RHEUMATOID ARTHRITIS | 0/38 (0%) | 1/39 (2.6%) | ||
| ROTATOR CUFF SYNDROME | 0/38 (0%) | 1/39 (2.6%) | ||
| SPINAL DISORDER | 1/38 (2.6%) | 0/39 (0%) | ||
| SPINAL OSTEOARTHRITIS | 1/38 (2.6%) | 1/39 (2.6%) | ||
| SPONDYLITIS | 2/38 (5.3%) | 0/39 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| BASAL CELL CARCINOMA | 1/38 (2.6%) | 0/39 (0%) | ||
| LIPOMA | 0/38 (0%) | 1/39 (2.6%) | ||
| MALIGNANT MELANOMA IN SITU | 0/38 (0%) | 1/39 (2.6%) | ||
| MESOTHELIOMA | 1/38 (2.6%) | 0/39 (0%) | ||
| METASTASES TO BONE | 2/38 (5.3%) | 1/39 (2.6%) | ||
| RENAL CANCER | 0/38 (0%) | 1/39 (2.6%) | ||
| SQUAMOUS CELL CARCINOMA OF SKIN | 1/38 (2.6%) | 0/39 (0%) | ||
| THYROID CANCER | 1/38 (2.6%) | 0/39 (0%) | ||
| TUMOUR PAIN | 0/38 (0%) | 1/39 (2.6%) | ||
| Nervous system disorders | ||||
| DEMENTIA | 1/38 (2.6%) | 0/39 (0%) | ||
| DIABETIC NEUROPATHY | 1/38 (2.6%) | 0/39 (0%) | ||
| DIZZINESS | 1/38 (2.6%) | 0/39 (0%) | ||
| DYSGEUSIA | 1/38 (2.6%) | 0/39 (0%) | ||
| EPILEPSY | 0/38 (0%) | 1/39 (2.6%) | ||
| ESSENTIAL TREMOR | 1/38 (2.6%) | 0/39 (0%) | ||
| GUILLAIN-BARRE SYNDROME | 0/38 (0%) | 1/39 (2.6%) | ||
| HEADACHE | 3/38 (7.9%) | 2/39 (5.1%) | ||
| LETHARGY | 0/38 (0%) | 1/39 (2.6%) | ||
| MIGRAINE | 1/38 (2.6%) | 1/39 (2.6%) | ||
| NEUROPATHY PERIPHERAL | 1/38 (2.6%) | 5/39 (12.8%) | ||
| PARAESTHESIA | 1/38 (2.6%) | 0/39 (0%) | ||
| PIRIFORMIS SYNDROME | 0/38 (0%) | 1/39 (2.6%) | ||
| RADICULOPATHY | 0/38 (0%) | 1/39 (2.6%) | ||
| RESTLESS LEGS SYNDROME | 1/38 (2.6%) | 0/39 (0%) | ||
| TRANSIENT ISCHAEMIC ATTACK | 0/38 (0%) | 1/39 (2.6%) | ||
| VERTEBROBASILAR INSUFFICIENCY | 0/38 (0%) | 1/39 (2.6%) | ||
| Psychiatric disorders | ||||
| ALCOHOL ABUSE | 0/38 (0%) | 1/39 (2.6%) | ||
| ANXIETY | 3/38 (7.9%) | 3/39 (7.7%) | ||
| CLAUSTROPHOBIA | 0/38 (0%) | 1/39 (2.6%) | ||
| DEPRESSION | 6/38 (15.8%) | 4/39 (10.3%) | ||
| DRUG ABUSE | 0/38 (0%) | 1/39 (2.6%) | ||
| INSOMNIA | 6/38 (15.8%) | 5/39 (12.8%) | ||
| LIBIDO DECREASED | 1/38 (2.6%) | 0/39 (0%) | ||
| MENTAL STATUS CHANGES | 1/38 (2.6%) | 0/39 (0%) | ||
| MIDDLE INSOMNIA | 0/38 (0%) | 1/39 (2.6%) | ||
| PSYCHOTIC DISORDER DUE TO GENERA MEDICAL CONDITION | 1/38 (2.6%) | 0/39 (0%) | ||
| Renal and urinary disorders | ||||
| BLADDER DIVERTICULUM | 1/38 (2.6%) | 0/39 (0%) | ||
| BLADDER NECK OBSTRUCTION | 0/38 (0%) | 1/39 (2.6%) | ||
| CHROMATURIA | 1/38 (2.6%) | 0/39 (0%) | ||
| DYSURIA | 2/38 (5.3%) | 0/39 (0%) | ||
| HAEMATURIA | 4/38 (10.5%) | 2/39 (5.1%) | ||
| HYPERTONIC BLADDER | 2/38 (5.3%) | 0/39 (0%) | ||
| HYDRONEPHROSIS | 2/38 (5.3%) | 0/39 (0%) | ||
| LOWER URINARY TRACT SYMPTOMS | 0/38 (0%) | 2/39 (5.1%) | ||
| MICTURITION URGENCY | 3/38 (7.9%) | 2/39 (5.1%) | ||
| NEPHROLITHIASIS | 1/38 (2.6%) | 2/39 (5.1%) | ||
| NOCTURIA | 14/38 (36.8%) | 3/39 (7.7%) | ||
| POLLAKIURIA | 8/38 (21.1%) | 4/39 (10.3%) | ||
| STRESS URINARY INCONTINENCE | 1/38 (2.6%) | 1/39 (2.6%) | ||
| TERMINAL DRIBBLING | 2/38 (5.3%) | 0/39 (0%) | ||
| URINARY HESITATION | 1/38 (2.6%) | 1/39 (2.6%) | ||
| URINARY INCONTINENCE | 4/38 (10.5%) | 1/39 (2.6%) | ||
| URINARY RETENTION | 2/38 (5.3%) | 1/39 (2.6%) | ||
| URINE FLOW DECREASED | 1/38 (2.6%) | 1/39 (2.6%) | ||
| URINE ODOUR ABNORMAL | 1/38 (2.6%) | 0/39 (0%) | ||
| URETHRAL STENOSIS | 2/38 (5.3%) | 0/39 (0%) | ||
| Reproductive system and breast disorders | ||||
| BALANITIS | 1/38 (2.6%) | 0/39 (0%) | ||
| BENIGN PROSTATIC HYPERPLASIA | 5/38 (13.2%) | 5/39 (12.8%) | ||
| BREAST PAIN | 1/38 (2.6%) | 1/39 (2.6%) | ||
| ERECTILE DYSFUNCTION | 17/38 (44.7%) | 5/39 (12.8%) | ||
| GYNAECOMASTIA | 3/38 (7.9%) | 1/39 (2.6%) | ||
| PELVIC PAIN | 2/38 (5.3%) | 0/39 (0%) | ||
| PROSTATE INDURATION | 0/38 (0%) | 1/39 (2.6%) | ||
| PROSTATOMEGALY | 0/38 (0%) | 1/39 (2.6%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| ASTHMA | 1/38 (2.6%) | 1/39 (2.6%) | ||
| ATELECTASIS | 1/38 (2.6%) | 0/39 (0%) | ||
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 1/38 (2.6%) | 2/39 (5.1%) | ||
| COUGH | 1/38 (2.6%) | 1/39 (2.6%) | ||
| DYSPNOEA | 1/38 (2.6%) | 0/39 (0%) | ||
| PHARYNGEAL CYST | 0/38 (0%) | 1/39 (2.6%) | ||
| PULMONARY FIBROSIS | 0/38 (0%) | 1/39 (2.6%) | ||
| PULMONARY GRANULOMA | 1/38 (2.6%) | 0/39 (0%) | ||
| RHINITIS ALLERGIC | 3/38 (7.9%) | 1/39 (2.6%) | ||
| RHINORRHOEA | 2/38 (5.3%) | 0/39 (0%) | ||
| SLEEP APNOEA SYNDROME | 3/38 (7.9%) | 1/39 (2.6%) | ||
| UPPER-AIRWAY COUGH SYNDROME | 0/38 (0%) | 1/39 (2.6%) | ||
| Skin and subcutaneous tissue disorders | ||||
| ACTINIC KERATOSIS | 1/38 (2.6%) | 0/39 (0%) | ||
| NIGHT SWEATS | 1/38 (2.6%) | 2/39 (5.1%) | ||
| SKIN HYPERPIGMENTATION | 1/38 (2.6%) | 0/39 (0%) | ||
| SOLAR DERMATITIS | 1/38 (2.6%) | 0/39 (0%) | ||
| Surgical and medical procedures | ||||
| ABDOMINAL HERNIA REPAIR | 0/38 (0%) | 2/39 (5.1%) | ||
| APPENDICECTOMY | 3/38 (7.9%) | 0/39 (0%) | ||
| ARTIFICIAL URINARY SPHINCTER IMPLANT | 1/38 (2.6%) | 0/39 (0%) | ||
| BLADDER CALCULUS REMOVAL | 1/38 (2.6%) | 0/39 (0%) | ||
| BLADDER NEOPLASM SURGERY | 1/38 (2.6%) | 0/39 (0%) | ||
| CATARACT OPERATION | 2/38 (5.3%) | 1/39 (2.6%) | ||
| CHOLECYSTECTOMY | 4/38 (10.5%) | 2/39 (5.1%) | ||
| CIRCUMCISION | 1/38 (2.6%) | 0/39 (0%) | ||
| COLECTOMY | 1/38 (2.6%) | 0/39 (0%) | ||
| CYST REMOVAL | 1/38 (2.6%) | 0/39 (0%) | ||
| DEBRIDEMENT | 1/38 (2.6%) | 0/39 (0%) | ||
| DUODENAL ULCER REPAIR | 1/38 (2.6%) | 0/39 (0%) | ||
| FRACTURE TREATMENT | 1/38 (2.6%) | 1/39 (2.6%) | ||
| GASTRIC ULCER SURGERY | 1/38 (2.6%) | 0/39 (0%) | ||
| HAEMORRHOID OPERATION | 2/38 (5.3%) | 1/39 (2.6%) | ||
| HERNIA REPAIR | 1/38 (2.6%) | 1/39 (2.6%) | 1 | |
| HIP SURGERY | 1/38 (2.6%) | 0/39 (0%) | ||
| INGUINAL HERNIA REPAIR | 1/38 (2.6%) | 0/39 (0%) | ||
| JOINT DISLOCATION REDUCTION | 0/38 (0%) | 1/39 (2.6%) | ||
| KNEE OPERATION | 1/38 (2.6%) | 0/39 (0%) | ||
| OPEN REDUCTION OF FRACTURE | 1/38 (2.6%) | 0/39 (0%) | ||
| RETINAL OPERATION | 0/38 (0%) | 2/39 (5.1%) | ||
| CHONDROPLASTY | 1/38 (2.6%) | 0/39 (0%) | ||
| SKIN NEOPLASM EXCISION | 2/38 (5.3%) | 0/39 (0%) | ||
| SPINAL FUSION SURGERY | 0/38 (0%) | 1/39 (2.6%) | ||
| SPINAL LAMINECTOMY | 1/38 (2.6%) | 0/39 (0%) | ||
| STENT PLACEMENT | 1/38 (2.6%) | 0/39 (0%) | ||
| TENDON OPERATION | 1/38 (2.6%) | 0/39 (0%) | ||
| THYROIDECTOMY | 0/38 (0%) | 2/39 (5.1%) | ||
| TONSILLECTOMY | 3/38 (7.9%) | 3/39 (7.7%) | ||
| TYMPANOPLASTY | 0/38 (0%) | 1/39 (2.6%) | ||
| URETHROTOMY | 1/38 (2.6%) | 0/39 (0%) | ||
| VARICOSE VEIN OPERATION | 0/38 (0%) | 1/39 (2.6%) | ||
| VASECTOMY | 2/38 (5.3%) | 2/39 (5.1%) | ||
| WISDOM TEETH REMOVAL | 1/38 (2.6%) | 0/39 (0%) | ||
| AORTIC ANEURYSM | 2/38 (5.3%) | 0/39 (0%) | ||
| AORTIC DISSECTION | 1/38 (2.6%) | 0/39 (0%) | ||
| Vascular disorders | ||||
| ARTERIOSCLEROSIS | 1/38 (2.6%) | 1/39 (2.6%) | ||
| EMBOLISM | 1/38 (2.6%) | 0/39 (0%) | ||
| HOT FLUSH | 10/38 (26.3%) | 11/39 (28.2%) | ||
| HYPERTENSION | 24/38 (63.2%) | 23/39 (59%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Mary Breitmeyer |
|---|---|
| Organization | Oncternal |
| Phone | 858-434-1113 |
| MBreitmeyer@oncternal.com |
- G200712