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)(TERMINATED) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00651807

Purpose

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.

Condition	Intervention	Phase
Benign Prostatic Hyperplasia (BPH)	Drug: etonogestrel Drug: Placebo	Phase II

Drug Information available for: Etonogestrel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Organon:

Primary Outcome Measures:

The effect of Org 3236 on prostate volume compared to placebo [ Time Frame: Screening (days -30 to -1), weeks 8, 12 and 24 ] [ Designated as safety issue: No ]
The effect of Org 3236 on LUTS compared to placebo [ Time Frame: Screening up to and including week 24 ] [ Designated as safety issue: No ]
The effect of Org 3236 on urinary flow and postvoid residual volume compared to placebo [ Time Frame: Screening and weeks 2 - 24 ] [ Designated as safety issue: No ]
The effect on progression of LUTS [ Time Frame: Screening up to and including week 24 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
The safety of Org 3236 [ Time Frame: Screening up to and including week 24 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]

Enrollment:	16
Study Start Date:	March 2008
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Active Comparator etonogestrel	Drug: etonogestrel 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
Arm 2: Placebo Comparator Placebo	Drug: Placebo Every day one tablet up to 8 weeks

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications:

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.

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. Review. No abstract available.

Responsible Party:	NV Organon, a part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	304001
Study First Received:	March 31, 2008
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00651807 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Germany: Federal Institute for Drugs and Medical Devices; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Hypertrophy
Hyperplasia
Desogestrel
Prostatic Diseases
Prostatic Hyperplasia

Contraceptive Agents
Contraceptive Agents, Female
3-keto-desogestrel
Genital Diseases, Male

Additional relevant MeSH terms:

Hyperplasia
Pathologic Processes
Prostatic Diseases
Prostatic Hyperplasia
Contraceptive Agents
Therapeutic Uses

Physiological Effects of Drugs
Contraceptive Agents, Female
Reproductive Control Agents
3-keto-desogestrel
Genital Diseases, Male
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009