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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

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

NCT ID

NCT00651807

First Posted

March 31, 2008

Last Updated

February 2, 2022

Sponsor

Organon and Co

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

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

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

Learn more about this trial

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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