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