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Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer

Sponsor
Camurus AB (Industry)
Overall Status
Completed
CT.gov ID
NCT02212197
Collaborator
(none)
51
Enrollment
7
Locations
3
Arms
18
Duration (Months)
7.3
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and safety of CAM2032 versus Eligard, in patients with prostate cancer. All patients will receive leuprolide acetate administered subcutaneously once monthly during 3 months.

Condition or Disease Intervention/Treatment Phase
  • Drug: leuprolide acetate FluidCrystal® injection depot
  • Drug: leuprolide acetate
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II, Open Label, Active Control, Multi-National, Multi-Centre, Randomized, Parallel Group Study Assessing Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of CAM2032 (Leuprolide Acetate FluidCrystal® Injection Depot Once Monthly) After Repeat Doses of 3.75 mg and 7.5 mg of Leuprolide Acetate vs. Eligard® 7.5 mg in Patients With Prostate Cancer
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: CAM2032 3.75 mg

Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.

Drug: leuprolide acetate FluidCrystal® injection depot
Other Names:
  • CAM2032

    		•
    Experimental: CAM2032 7.5 mg

    Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.

    Drug: leuprolide acetate FluidCrystal® injection depot
    Other Names:
  • CAM2032

    		•
    Active Comparator: Eligard 7.5 mg

    Single subcutaneous buttock injections of Eligard® (leuprolide acetate) 7.5 mg on Days 0, 28 and 56.

    Drug: leuprolide acetate
    Other Names:
  • Eligard

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3 [84 days]

      Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, Cmax was derived for Doses 1 and 3 of the investigational medicinal product (IMP).

    2. Apparent Terminal Half-life (t½) for Dose 1 and Dose 3 [Days 0-28 and Days 56-84]

      Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, t1/2 was derived for Doses 1 and 3 of the IMP.

    3. Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3 [Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3)]

      Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, AUCtau was derived for Doses 1 and 3 of the IMP.

    Secondary Outcome Measures

    1. Time (Days) to Testosterone Recovery After Dose 3 [Days 56-126]

      The pharmacodynamic (PD) effects of leuprolide were assessed by measuring serum testosterone during the trial. Time to testosterone recovery after last dose of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.

    2. Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP) [Days 0-126]

      The PD effects of leuprolide were assessed by measuring serum testosterone concentrations during the trial. The following PD variable was analyzed: The profiles of testosterone concentration (ng/dL) following injections of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.

    3. Mean Prostate Specific Antigen (PSA) Concentration [Days 0-126]

      The PD effects of leuprolide were assessed by measuring serum PSA concentrations during the trial. The following PD variable was analyzed: PSA (ng/mL) response to IMP. Blood samples for analyses of plasma PSA concentrations were collected at Screening and on Days 0 to 126.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 85 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Men ≥40 and ≤85 years of age

    • Histological or cytological proven adenocarcinoma of the prostate requiring hormone therapy

    • Life expectancy over 12 months

    • World Health Organisation/ The Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0, 1 or 2

    • Adequate and stable renal function

    • Adequate and stable hepatic function

    Exclusion Criteria:

    • Evidence of brain metastasis, spinal cord compression, or urinary tract obstruction

    • Serum Testosterone levels below 150 ng/dL at Screening visit

    • Medical or radiological prostate cancer treatments within 2 months prior to the Screening visit

    • Surgical treatment of prostate cancer within 2 weeks prior to the Screening visit

    • Prior orchiectomy, hypophysectomy, or adrenalectomy

    • Prior use of LHRH agonists within 12 months prior to the Screening visit and during the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Docrates Cancer Center Helsinki Finland
    2 University Hospital of Helsinki, Department of Urology Helsinki Finland
    3 Tampere University Hospital, Department of Urology Tampere Finland
    4 University Hospital of Turku, Department of Urology Turku Finland
    5 Semmelweis University Hospital Department of Urology Budapest Hungary
    6 Szent Imre Teaching Hospital Budapest Hungary
    7 University of Debrecen, Medical Health Sciences Center, Department of Urology Debrecen Hungary

    Sponsors and Collaborators

    • Camurus AB

    Investigators

    • Principal Investigator: Teuvo Tammela, Prof, Tampere University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Camurus AB
    ClinicalTrials.gov Identifier:
    NCT02212197
    Other Study ID Numbers:
    • HS-12-460
    First Posted:
    Aug 8, 2014
    Last Update Posted:
    Apr 25, 2017
    Last Verified:
    Mar 1, 2017
    Keywords provided by Camurus AB
    prostate cancer
    leuprolide
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Leuprolide

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg
    Arm/Group Description Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56. Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56. Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
    Period Title: Overall Study
    STARTED 19 15 17
    COMPLETED 18 15 17
    NOT COMPLETED 1 0 0

    Baseline Characteristics

    Arm/Group Title CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg Total
    Arm/Group Description Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56. Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56. Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56. Total of all reporting groups
    Overall Participants 19 15 17 51
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    6
    31.6%
    1
    6.7%
    2
    11.8%
    9
    17.6%
    >=65 years
    13
    68.4%
    14
    93.3%
    15
    88.2%
    42
    82.4%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    69.7
    (9.5)
    71.9
    (6.3)
    70.9
    (7)
    70.8
    (7.8)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Male
    19
    100%
    15
    100%
    17
    100%
    51
    100%
    Region of Enrollment (participants) [Number]
    Hungary
    6
    31.6%
    5
    33.3%
    9
    52.9%
    20
    39.2%
    Finland
    13
    68.4%
    10
    66.7%
    8
    47.1%
    31
    60.8%

    Outcome Measures

    1. Primary Outcome
    Title Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3
    Description Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, Cmax was derived for Doses 1 and 3 of the investigational medicinal product (IMP).
    Time Frame 84 days

    Outcome Measure Data

    Analysis Population Description
    The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.
    Arm/Group Title CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg
    Arm/Group Description Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56. Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56. Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
    Measure Participants 15 15 17
    Dose 1
    6.14
    (41.1)
    9.66
    (31.5)
    13.6
    (54.7)
    Dose 3
    5.36
    (33.3)
    11.3
    (36.8)
    12.1
    (47.3)
    2. Primary Outcome
    Title Apparent Terminal Half-life (t½) for Dose 1 and Dose 3
    Description Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, t1/2 was derived for Doses 1 and 3 of the IMP.
    Time Frame Days 0-28 and Days 56-84

    Outcome Measure Data

    Analysis Population Description
    The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.
    Arm/Group Title CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg
    Arm/Group Description Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56. Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56. Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
    Measure Participants 15 15 17
    Dose 1
    205
    (113)
    231
    (142)
    743
    (1677)
    Dose 3
    299
    (277)
    434
    (867)
    378
    (570)
    3. Primary Outcome
    Title Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3
    Description Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, AUCtau was derived for Doses 1 and 3 of the IMP.
    Time Frame Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3)

    Outcome Measure Data

    Analysis Population Description
    The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.
    Arm/Group Title CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg
    Arm/Group Description Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56. Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56. Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
    Measure Participants 15 15 17
    Dose 1
    329
    (37.6)
    622
    (45.2)
    397
    (45.3)
    Dose 3
    343
    (24.7)
    757
    (53.4)
    460
    (62.2)
    4. Secondary Outcome
    Title Time (Days) to Testosterone Recovery After Dose 3
    Description The pharmacodynamic (PD) effects of leuprolide were assessed by measuring serum testosterone during the trial. Time to testosterone recovery after last dose of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.
    Time Frame Days 56-126

    Outcome Measure Data

    Analysis Population Description
    The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.
    Arm/Group Title CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg
    Arm/Group Description Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56. Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56. Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
    Measure Participants 15 15 17
    Mean (Standard Deviation) [days]
    46.2
    (13.6)
    52.3
    (20.6)
    65
    (5.7)
    5. Secondary Outcome
    Title Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)
    Description The PD effects of leuprolide were assessed by measuring serum testosterone concentrations during the trial. The following PD variable was analyzed: The profiles of testosterone concentration (ng/dL) following injections of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.
    Time Frame Days 0-126

    Outcome Measure Data

    Analysis Population Description
    The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.
    Arm/Group Title CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg
    Arm/Group Description Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56. Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56. Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
    Measure Participants 15 15 17
    Day 0 (predose)
    443
    321
    350
    Day 28 (predose)
    20.9
    24.5
    18.1
    Day 56 (predose)
    14.6
    13.8
    12
    Day 84
    14.8
    10.6
    12.4
    Day 126
    423
    278
    85.8
    6. Secondary Outcome
    Title Mean Prostate Specific Antigen (PSA) Concentration
    Description The PD effects of leuprolide were assessed by measuring serum PSA concentrations during the trial. The following PD variable was analyzed: PSA (ng/mL) response to IMP. Blood samples for analyses of plasma PSA concentrations were collected at Screening and on Days 0 to 126.
    Time Frame Days 0-126

    Outcome Measure Data

    Analysis Population Description
    The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.
    Arm/Group Title CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg
    Arm/Group Description Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56. Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56. Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
    Measure Participants 15 15 17
    Day 0 (predose)
    14.9
    18.8
    14.6
    Day 28 (predose)
    9
    8.3
    4.6
    Day 56 (predose)
    3.6
    5.8
    2.1
    Day 84
    2.3
    2.6
    1.6
    Day 126
    4.7
    3.1
    1.6

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg
    Arm/Group Description Single subcutaneous buttock injections of CAM2032 3.75 mg on Days 0, 28 and 56. Single subcutaneous buttock injections of CAM2032 7.5 mg on Days 0, 28 and 56. Single subcutaneous buttock injections of Eligard 7.5 mg on Days 0, 28 and 56.
    All Cause Mortality
    CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/19 (0%) 1/15 (6.7%) 0/17 (0%)
    Infections and infestations
    Urinary tract infection 0/19 (0%) 0 1/15 (6.7%) 1 0/17 (0%) 0
    Psychiatric disorders
    Disorientation 0/19 (0%) 0 1/15 (6.7%) 1 0/17 (0%) 0
    Renal and urinary disorders
    Calculus urinary 0/19 (0%) 0 1/15 (6.7%) 1 0/17 (0%) 0
    Other (Not Including Serious) Adverse Events
    CAM2032 3.75 mg CAM2032 7.5 mg Eligard 7.5 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 14/19 (73.7%) 12/15 (80%) 10/17 (58.8%)
    Cardiac disorders
    Angina pectoris 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Arrhytmia 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Eye disorders
    Vision blurred 0/19 (0%) 0 1/15 (6.7%) 1 1/17 (5.9%) 1
    Conjunctival haemorrhage 0/19 (0%) 0 0/15 (0%) 0 1/17 (5.9%) 1
    Eye pain 0/19 (0%) 0 1/15 (6.7%) 1 0/17 (0%) 0
    Gastrointestinal disorders
    Nausea 4/19 (21.1%) 5 0/15 (0%) 0 0/17 (0%) 0
    Diarrhoea 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Inguinal hernia 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Dry mouth 0/19 (0%) 0 1/15 (6.7%) 1 0/17 (0%) 0
    General disorders
    Pyrexia 0/19 (0%) 0 0/15 (0%) 0 2/17 (11.8%) 3
    Injection site erythema 0/19 (0%) 0 1/15 (6.7%) 2 0/17 (0%) 0
    Fatigue 0/19 (0%) 0 0/15 (0%) 0 1/17 (5.9%) 1
    Injection site nodule 0/19 (0%) 0 1/15 (6.7%) 1 0/17 (0%) 0
    Oedema peripheral 0/19 (0%) 0 0/15 (0%) 0 1/17 (5.9%) 1
    Pain 0/19 (0%) 0 1/15 (6.7%) 1 0/17 (0%) 0
    Infections and infestations
    Influenza 3/19 (15.8%) 6 3/15 (20%) 3 1/17 (5.9%) 1
    Abscess 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Bronchitis 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Gastroenteritis 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Localised infection 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Nasopharyngitis 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Sinusitis 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Gastroenteritis viral 0/19 (0%) 0 0/15 (0%) 0 1/17 (5.9%) 1
    Herpes zoster 0/19 (0%) 0 0/15 (0%) 0 1/17 (5.9%) 1
    Upper respiratory tract infection 0/19 (0%) 0 1/15 (6.7%) 1 0/17 (0%) 0
    Injury, poisoning and procedural complications
    Fall 3/19 (15.8%) 3 0/15 (0%) 0 1/17 (5.9%) 1
    Ligament sprain 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Muscle strain 0/19 (0%) 0 1/15 (6.7%) 1 0/17 (0%) 0
    Investigations
    Blood creatine phosphokinase increased 1/19 (5.3%) 1 0/15 (0%) 0 1/17 (5.9%) 1
    Gamma-glutamyltransferase increased 1/19 (5.3%) 1 0/15 (0%) 0 1/17 (5.9%) 1
    Alanine aminotransferase increased 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Blood glucose increased 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    C-reactive protein increased 0/19 (0%) 0 0/15 (0%) 0 1/17 (5.9%) 1
    Blood urine 0/19 (0%) 0 0/15 (0%) 0 1/17 (5.9%) 1
    Metabolism and nutrition disorders
    Hypercholesterolaemia 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 0/19 (0%) 0 3/15 (20%) 4 1/17 (5.9%) 1
    Pain in extremity 1/19 (5.3%) 1 1/15 (6.7%) 1 2/17 (11.8%) 2
    Musculoskeletal pain 1/19 (5.3%) 2 0/15 (0%) 0 1/17 (5.9%) 1
    Arthralgia 0/19 (0%) 0 2/15 (13.3%) 2 1/17 (5.9%) 1
    Muscle spasm 0/19 (0%) 0 1/15 (6.7%) 1 1/17 (5.9%) 1
    Intervertebral disc disorder 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Myalgia 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Neck pain 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Bone pain 0/19 (0%) 0 0/15 (0%) 0 1/17 (5.9%) 1
    Bursitis 0/19 (0%) 0 0/15 (0%) 0 1/17 (5.9%) 1
    Groin pain 0/19 (0%) 0 1/15 (6.7%) 1 0/17 (0%) 0
    Musculoskeletal chest pain 0/19 (0%) 0 0/15 (0%) 0 1/17 (5.9%) 1
    Nervous system disorders
    Headache 0/19 (0%) 0 1/15 (6.7%) 2 3/17 (17.6%) 6
    Sciatica 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Syncope 0/19 (0%) 0 0/15 (0%) 0 1/17 (5.9%) 1
    Psychiatric disorders
    Insomnia 0/19 (0%) 0 0/15 (0%) 0 2/17 (11.8%) 2
    Depressed mood 0/19 (0%) 0 1/15 (6.7%) 1 0/17 (0%) 0
    Renal and urinary disorders
    Urinary retention 0/19 (0%) 0 2/15 (13.3%) 2 2/17 (11.8%) 2
    Haematuria 1/19 (5.3%) 1 1/15 (6.7%) 1 0/17 (0%) 0
    Nocturia 0/19 (0%) 0 2/15 (13.3%) 2 0/17 (0%) 0
    Haemorrhage urinary tract 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Micturition 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Bladder pain 0/19 (0%) 0 0/15 (0%) 0 1/17 (5.9%) 1
    Incontinence 0/19 (0%) 0 0/15 (0%) 0 1/17 (5.9%) 1
    Urethral pain 0/19 (0%) 0 1/15 (6.7%) 1 0/17 (0%) 0
    Reproductive system and breast disorders
    Prostatic pain 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Erectile dysfunction 0/19 (0%) 0 1/15 (6.7%) 1 0/17 (0%) 0
    Genital pain 0/19 (0%) 0 0/15 (0%) 0 1/17 (5.9%) 1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis 0/19 (0%) 0 1/15 (6.7%) 2 0/17 (0%) 0
    Rhinitis allergic 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0
    Dyspnea 0/19 (0%) 0 0/15 (0%) 0 1/17 (5.9%) 1
    Skin and subcutaneous tissue disorders
    Eczema 1/19 (5.3%) 1 1/15 (6.7%) 1 0/17 (0%) 0
    Vascular disorders
    Hot flush 8/19 (42.1%) 8 4/15 (26.7%) 4 5/17 (29.4%) 5
    Hypertension 3/19 (15.8%) 3 1/15 (6.7%) 1 0/17 (0%) 0
    Haematoma 1/19 (5.3%) 1 0/15 (0%) 0 0/17 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Clinical Trial Manager
    Organization Camurus AB
    Phone
    Email info@camurus.com
    Responsible Party:
    Camurus AB
    ClinicalTrials.gov Identifier:
    NCT02212197
    Other Study ID Numbers:
    • HS-12-460
    First Posted:
    Aug 8, 2014
    Last Update Posted:
    Apr 25, 2017
    Last Verified:
    Mar 1, 2017