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Inability to recruit patients
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| Name | Class |
|---|---|
| H2O Clinical LLC | INDUSTRY |
| Q2 Solutions | INDUSTRY |
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The objective of this clinical study is to evaluate the safety and efficacy of three different doses of BHR-200 (0.36% transdermal estradiol gel) compared to placebo for the maintenance of testosterone (T) suppression in men with advanced androgen-sensitive prostate cancer.
This is a multi-center, randomized, double-blind, placebo-controlled, dose finding study in men with advanced androgen-sensitive prostate cancer. Patients who give informed consent will have screening evaluations, and if fulfilling the entry criteria, will be randomized to one of 4 treatment groups: 1mL, 2mL or 3mL of 0.36% BHR-200 (transdermal estradiol gel) or Placebo. Study drug will be initiated on the day they were scheduled to receive next depot GnRH agonist injection. Patients will be offered low-dose radiation to aid in the prevention of gynecomastia. Patients will apply the study drug once per day. The first dose of study gel will be applied under the supervision of the PI/designee. Subsequent doses will be self-administered daily by the patient until he is no longer chemically castrated (testosterone levels increase above 50 ng/dL), a rise over baseline PSA of > 0.5 ng/mL is observed, or he has completed 52 weeks of study drug administration. At the conclusion of study participation, patients will be advised to resume standard of care treatment under the supervision of their healthcare provider. While on treatment, patients will be evaluated at Day 1 and every 2 weeks, for the first 24 weeks and every 4 weeks thereafter with a final post-treatment follow-up visit 2 weeks (+/- 1 week) post last dose administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BHR-200 Low Dose | Experimental | 3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks. |
|
| BHR-200 Mid Dose | Experimental | 6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks. |
|
| BHR-200 High Dose | Experimental | 9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks. |
|
| Placebo | Placebo Comparator | 1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BHR-200 (0.36% transdermal 17β-estradiol gel) | Drug | An absorptive hydroalcoholic gel preparation containing 17β-estradiol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of Testosterone Suppression at Week 12 | Primary Efficacy Endpoint was the percentage of patients failing to maintain castrate levels of T (T < 50 ng/dL). Testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 4 to 12. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of Testosterone Suppression at Week 24 | Pproportion of patients failing to maintaincastrate levels of T (T < 50 ng/dL). Testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 4 to 24. | Week 24 |
| Number of Patients Reporting Thromboembolic Adverse Events |
| Measure | Description | Time Frame |
|---|---|---|
| Luteinizing Hormone (LH) | Serum concentrations of luteinizing hormone (LH) | Reported for Baseline, Week 12, Week 24, Week 36 and Week 48 |
| Sex Hormone Binding Globulin (SHBG) | Serum concentrations of sex hormone binding globulin (SHBG) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roland Gerritsen van der Hoop, MD, PhD | BHR Pharma, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urological Associates of Southern Arizona | Tucson | Arizona | 85741 | United States | ||
| South Florida Medical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12686820 | Background | Ockrim JL, Lalani EN, Laniado ME, Carter SS, Abel PD. Transdermal estradiol therapy for advanced prostate cancer--forward to the past? J Urol. 2003 May;169(5):1735-7. doi: 10.1097/01.ju.0000061024.75334.40. | |
| 16006886 | Background | Ockrim JL, Lalani el-N, Kakkar AK, Abel PD. Transdermal estradiol therapy for prostate cancer reduces thrombophilic activation and protects against thromboembolism. J Urol. 2005 Aug;174(2):527-33; discussion 532-3. doi: 10.1097/01.ju.0000165567.99142.1f. |
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| ID | Title | Description |
|---|---|---|
| FG000 | BHR-200 Low Dose | 3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks. BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol. |
| FG001 | BHR-200 Mid Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 24-Week Double-Blind Main Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 13, 2016 | Nov 18, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol. |
|
Number of patients and severity of thromboembolic adverse events |
| To Week 52/End of Study: Both 24-Week Main Study and Optional 28-Week Extension Study |
| Reported for Baseline, Week 12, Week 24, Week 36 and Week 48 |
| Prostate Specific Antigen (PSA) | Serum concentrations of prostate specific antigen (PSA) | To Week 52/End of Study: Both 24-Week Main Study and Optional 28-Week Extension Study |
| Follicle-stimulating Hormone (FSH) | Serum concentrations of follicle-stimulating hormone (FSH) | Reported for Baseline, Week 12, Week 24, Week 36 and Week 48 |
| Maintenance of Testosterone Suppression at Week 52/ End of Study | Proportion of patients failing to maintain castrate levels of T (T < 50 ng/dL). Testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 24 to 52/End of Study | Double-blind 28-Week Optional Extension Study from Week 24 to Week 52/End of Study |
| Aventura |
| Florida |
| 33180 |
| United States |
| Advanced Urology Institute | Daytona Beach | Florida | 32114 | United States |
| Adult Pediatric Urology, PC | Council Bluffs | Iowa | 51501 | United States |
| Adult Pediatric Urology, PC | Omaha | Nebraska | 68114 | United States |
| Delaware Valley Urology | Voorhees Township | New Jersey | 08043 | United States |
| AccumetRX Clinical Trials | Albuquerque | New Mexico | 87109 | United States |
| Associated Medical Professionals of NY (AMP of NY) | Syracuse | New York | 13210 | United States |
| Eastern Urological Associates | Greenville | North Carolina | 27834 | United States |
| Urologic Consultants of Southeastern Pennsylvania (UCSEPA) | Bala-Cynwyd | Pennsylvania | 19044 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| Urology Clinics of North Texas | Dallas | Texas | 75231 | United States |
| 18809586 | Background | Ockrim JL, Abel PD. Long term androgen deprivation therapy in prostate cancer. BMJ. 2008 Sep 22;337:a1361. doi: 10.1136/bmj.a1361. No abstract available. |
| 17019433 | Background | Ockrim J, Lalani el-N, Abel P. Therapy Insight: parenteral estrogen treatment for prostate cancer--a new dawn for an old therapy. Nat Clin Pract Oncol. 2006 Oct;3(10):552-63. doi: 10.1038/ncponc0602. |
| 18422771 | Background | Langley RE, Godsland IF, Kynaston H, Clarke NW, Rosen SD, Morgan RC, Pollock P, Kockelbergh R, Lalani el-N, Dearnaley D, Parmar M, Abel PD. Early hormonal data from a multicentre phase II trial using transdermal oestrogen patches as first-line hormonal therapy in patients with locally advanced or metastatic prostate cancer. BJU Int. 2008 Aug;102(4):442-5. doi: 10.1111/j.1464-410X.2008.07583.x. Epub 2008 Apr 16. |
| 23465742 | Background | Langley RE, Cafferty FH, Alhasso AA, Rosen SD, Sundaram SK, Freeman SC, Pollock P, Jinks RC, Godsland IF, Kockelbergh R, Clarke NW, Kynaston HG, Parmar MK, Abel PD. Cardiovascular outcomes in patients with locally advanced and metastatic prostate cancer treated with luteinising-hormone-releasing-hormone agonists or transdermal oestrogen: the randomised, phase 2 MRC PATCH trial (PR09). Lancet Oncol. 2013 Apr;14(4):306-16. doi: 10.1016/S1470-2045(13)70025-1. Epub 2013 Mar 4. |
| 15641029 | Background | Bland LB, Garzotto M, DeLoughery TG, Ryan CW, Schuff KG, Wersinger EM, Lemmon D, Beer TM. Phase II study of transdermal estradiol in androgen-independent prostate carcinoma. Cancer. 2005 Feb 15;103(4):717-23. doi: 10.1002/cncr.20857. |
| 7500443 | Background | Cox RL, Crawford ED. Estrogens in the treatment of prostate cancer. J Urol. 1995 Dec;154(6):1991-8. |
| 17239273 | Background | Lycette JL, Bland LB, Garzotto M, Beer TM. Parenteral estrogens for prostate cancer: can a new route of administration overcome old toxicities? Clin Genitourin Cancer. 2006 Dec;5(3):198-205. doi: 10.3816/CGC.2006.n.037. |
| 14644018 | Background | Sayed Y, Taxel P. The use of estrogen therapy in men. Curr Opin Pharmacol. 2003 Dec;3(6):650-4. doi: 10.1016/j.coph.2003.07.004. |
6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks. BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol. |
| FG002 | BHR-200 High Dose | 9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks. BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol. |
| FG003 | Placebo | 1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks. Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| 28-Week Double-Blind Optional Extension |
|
|
Safety Population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BHR-200 Low Dose | 3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks. BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol. |
| BG001 | BHR-200 Mid Dose | 6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks. BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol. |
| BG002 | BHR-200 High Dose | 9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks. BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol. |
| BG003 | Placebo | 1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks. Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maintenance of Testosterone Suppression at Week 12 | Primary Efficacy Endpoint was the percentage of patients failing to maintain castrate levels of T (T < 50 ng/dL). Testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 4 to 12. | The Intent-to-treat (ITT) population contains all patients who are randomized into the study. All efficacy parameters were analyzed using the ITT population. In the case of a patient who was randomized but did not take the study drug, the analysis was done for this patient using the randomized treatment. | Posted | Count of Participants | Participants | Week 12 |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Maintenance of Testosterone Suppression at Week 24 | Pproportion of patients failing to maintaincastrate levels of T (T < 50 ng/dL). Testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 4 to 24. | The Intent-to-treat (ITT) population contains all patients who are randomized into the study. All efficacy parameters were analyzed using the ITT population. In the case of a patient who was randomized but did not take the study drug, the analysis was done for this patient using the randomized treatment. | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Reporting Thromboembolic Adverse Events | Number of patients and severity of thromboembolic adverse events | Safety Population | Posted | Count of Participants | Participants | To Week 52/End of Study: Both 24-Week Main Study and Optional 28-Week Extension Study |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Luteinizing Hormone (LH) | Serum concentrations of luteinizing hormone (LH) | Safety population: contains all patients who received at least one dose of study drug. | Posted | Mean | Standard Deviation | IU/L | Reported for Baseline, Week 12, Week 24, Week 36 and Week 48 |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Sex Hormone Binding Globulin (SHBG) | Serum concentrations of sex hormone binding globulin (SHBG) | Safety population: contains all patients who received at least one dose of study drug. | Posted | Mean | Standard Deviation | nmol/L | Reported for Baseline, Week 12, Week 24, Week 36 and Week 48 |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Prostate Specific Antigen (PSA) | Serum concentrations of prostate specific antigen (PSA) | Safety population: contains all patients who received at least one dose of study drug. | Posted | Mean | Standard Deviation | ng/ML | To Week 52/End of Study: Both 24-Week Main Study and Optional 28-Week Extension Study |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Follicle-stimulating Hormone (FSH) | Serum concentrations of follicle-stimulating hormone (FSH) | Safety population: contains all patients who received at least one dose of study drug. | Posted | Mean | Standard Deviation | IU/L | Reported for Baseline, Week 12, Week 24, Week 36 and Week 48 |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Maintenance of Testosterone Suppression at Week 52/ End of Study | Proportion of patients failing to maintain castrate levels of T (T < 50 ng/dL). Testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 24 to 52/End of Study | Intent-to-Treat | Posted | Count of Participants | Participants | Double-blind 28-Week Optional Extension Study from Week 24 to Week 52/End of Study |
|
AEs were captured for the duration of the study. The reporting period began with the first dose of Study Drug (Study Day 1) and ends at Week 24 or the End of Study. For participants who opted to enroll in the 28-week open-label extension study, AE collection continued to Week 52 or the End of Study.
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BHR-200 Low Dose | 3 mg estradiol per 1 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks. BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol. | 0 | 9 | 0 | 9 | 7 | 9 |
| EG001 | BHR-200 Mid Dose | 6 mg estradiol per 2 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks. BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG002 | BHR-200 High Dose | 9 mg estradiol per 3 mL 0.36% BHR-200 (transdermal 17β-estradiol gel) applied daily to the skin for up to 52 weeks. BHR-200 (0.36% transdermal 17β-estradiol gel): An absorptive hydroalcoholic gel preparation containing 17β-estradiol. | 0 | 9 | 2 | 9 | 9 | 9 |
| EG003 | Placebo | 1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks. Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol. | 0 | 8 | 0 | 8 | 4 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lymphoid tissue operation | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Application site pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nipple pain | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Breast enlargement | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nipple disorder | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lymphoid tissue operation | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Chief Medical Officer | Besins Healthcare Ireland Ltd | +353 87 1039215 | clinicaldevelopment@besins-healthcare.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 19, 2017 | Nov 18, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| Withdrawal by Subject |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | Placebo | 1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks. Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol. |
|
|
| Placebo |
1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks. Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol. |
|
|
| Placebo |
1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks. Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol. |
|
|
| OG003 |
| Placebo |
1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks. Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol. |
|
|
| OG003 |
| Placebo |
1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks. Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol. |
|
|
| Placebo |
1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks. Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol. |
|
|
| OG003 | Placebo | 1, 2 or 3 mL of Placebo gel containing 0 mg estradiol applied daily for up to 52 weeks. Placebo: An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol. |
|
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