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A Trial to Investigate the Effectiveness and Safety of Org 3236 (Etonogestrel) Tablets in Men With Urinary Complaints Suggestive of a Benign Enlargement of the Prostate (304001)(P05806)

Primary Purpose

Benign Prostatic Hyperplasia (BPH)

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
etonogestrel
Placebo
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH)

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed written informed consent, obtained before screening evaluations;
  • Men diagnosed with LUTS suggestive of BPH: Baseline IPSS score of = 12 (moderate to severe); Prostate volume of = 40 mL and < 100 mL (based on TRUS); Peak urinary flow rate = 15 mL/s with a voided volume of =125 mL
  • Age at least 50 but not older than 80 years at screening
  • PSA < 10 ng/mL and exclusion of prostate cancer to the satisfaction of the investigator (e.g. by biopsy)

Exclusion Criteria:

  • A post void residual volume >250 mL
  • Use of drugs interfering with efficacy assessments within two weeks or six months prior to start treatment (depending on drug)
  • Acute urinary retention within the past 12 months
  • History of surgery for BPH, including other minimally invasive procedures
  • Presence of urinary tract infection
  • Presence or history of (subclinical) prostate cancer, bladder cancer, urethral stricture, or pelvic irradiation
  • Cardiac or cerebrovascular event within the past six months
  • Presence or history of any neurological disease associated with primary bladder dysfunction
  • Presence or history of liver/renal disease or disturbance of liver/renal function that failed to return to normal
  • Clinically relevant abnormal laboratory result as judged by the (sub)investigator

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Arm 1

    Arm 2

    Arm Description

    etonogestrel

    Placebo

    Outcomes

    Primary Outcome Measures

    The effect of Org 3236 on prostate volume compared to placebo
    The effect of Org 3236 on LUTS compared to placebo
    The effect of Org 3236 on urinary flow and postvoid residual volume compared to placebo
    The effect on progression of LUTS
    The effect of Org 3236 on sexual function; well-being and LUTS-related Quality of Life compared to placebo
    The safety of Org 3236
    The pharmacokinetic (Org 3236) and pharmacodynamic (T, DHT, LH, FSH, E2, SHBG) properties

    Secondary Outcome Measures

    Full Information

    First Posted
    March 31, 2008
    Last Updated
    February 2, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00651807
    Brief Title
    A Trial to Investigate the Effectiveness and Safety of Org 3236 (Etonogestrel) Tablets in Men With Urinary Complaints Suggestive of a Benign Enlargement of the Prostate (304001)(P05806)
    Official Title
    Phase II, Randomized, Double-Blind, Placebo-Controlled Trial Investigating the Efficacy and Safety of Org 3236 Tablets in Men With Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia (BPH)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Terminated
    Why Stopped
    Business Reasons
    Study Start Date
    March 2008 (undefined)
    Primary Completion Date
    August 2008 (Actual)
    Study Completion Date
    August 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This trial is conducted to evaluate the effect of etonogestrel in comparison to placebo on: the prostate volume and the urinary complaints; the urinary flow and the urinary volume in the bladder after voiding; the progression of the disease; the sexual function, well-being and urinary complaints-related Quality of Life. In addition the safety and the way the drug is absorbed and excreted by the body will be analyzed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Benign Prostatic Hyperplasia (BPH)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Active Comparator
    Arm Description
    etonogestrel
    Arm Title
    Arm 2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    etonogestrel
    Other Intervention Name(s)
    Org 3236
    Intervention Description
    Lowest dose of Org 3236 per two days, lowest dose of Org 3236 per day, highest dose of Org 3236 per day for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Every day one tablet up to 8 weeks
    Primary Outcome Measure Information:
    Title
    The effect of Org 3236 on prostate volume compared to placebo
    Time Frame
    Screening (days -30 to -1), weeks 8, 12 and 24
    Title
    The effect of Org 3236 on LUTS compared to placebo
    Time Frame
    Screening up to and including week 24
    Title
    The effect of Org 3236 on urinary flow and postvoid residual volume compared to placebo
    Time Frame
    Screening and weeks 2 - 24
    Title
    The effect on progression of LUTS
    Time Frame
    Screening up to and including week 24
    Title
    The effect of Org 3236 on sexual function; well-being and LUTS-related Quality of Life compared to placebo
    Time Frame
    Screening and weeks 4 - 24; screening and weeks 2 - 24, respectively
    Title
    The safety of Org 3236
    Time Frame
    Screening up to and including week 24
    Title
    The pharmacokinetic (Org 3236) and pharmacodynamic (T, DHT, LH, FSH, E2, SHBG) properties
    Time Frame
    Randomization and weeks 2 - 8; randomization and weeks 2 - 12 and 24, respectively

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed written informed consent, obtained before screening evaluations; Men diagnosed with LUTS suggestive of BPH: Baseline IPSS score of = 12 (moderate to severe); Prostate volume of = 40 mL and < 100 mL (based on TRUS); Peak urinary flow rate = 15 mL/s with a voided volume of =125 mL Age at least 50 but not older than 80 years at screening PSA < 10 ng/mL and exclusion of prostate cancer to the satisfaction of the investigator (e.g. by biopsy) Exclusion Criteria: A post void residual volume >250 mL Use of drugs interfering with efficacy assessments within two weeks or six months prior to start treatment (depending on drug) Acute urinary retention within the past 12 months History of surgery for BPH, including other minimally invasive procedures Presence of urinary tract infection Presence or history of (subclinical) prostate cancer, bladder cancer, urethral stricture, or pelvic irradiation Cardiac or cerebrovascular event within the past six months Presence or history of any neurological disease associated with primary bladder dysfunction Presence or history of liver/renal disease or disturbance of liver/renal function that failed to return to normal Clinically relevant abnormal laboratory result as judged by the (sub)investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15474261
    Citation
    Madersbacher S, Alivizatos G, Nordling J, Sanz CR, Emberton M, de la Rosette JJ. EAU 2004 guidelines on assessment, therapy and follow-up of men with lower urinary tract symptoms suggestive of benign prostatic obstruction (BPH guidelines). Eur Urol. 2004 Nov;46(5):547-54. doi: 10.1016/j.eururo.2004.07.016.
    Results Reference
    background
    PubMed Identifier
    12882718
    Citation
    Gonzalez CM, McVary KT. The role of combination therapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia. Curr Urol Rep. 2003 Aug;4(4):276-81. doi: 10.1007/s11934-003-0084-1. No abstract available.
    Results Reference
    background
    Citation
    McConnell J, Abrams P, Denis L, Khoury S, Roehrborn C (eds). Male Lower Urinary Tract Dysfunction - Evaluation and Management. Edition 2006 Paris, France: Editions 21, ISBN 0-9546956-6-6.
    Results Reference
    background

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    A Trial to Investigate the Effectiveness and Safety of Org 3236 (Etonogestrel) Tablets in Men With Urinary Complaints Suggestive of a Benign Enlargement of the Prostate (304001)(P05806)

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