Benign Prostatic Hyperplasia (BPH)Phase 2NCT00651807
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)
A Phase 2 study testing etonogestrel in people with Benign Prostatic Hyperplasia (BPH), run by Organon and Co at 1 site in Argentina.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- etonogestrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteArgentina
- Study dates
- Mar 2008to Aug 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this 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)
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.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- etonogestrel, Placebo
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etonogestrelDrug
Also called Org 3236
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
PlaceboDrug
Every day one tablet up to 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | etonogestrel Receives: Drug: etonogestrel |
| Arm 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of Org 3236 on prostate volume compared to placebo
Measured: Screening (days -30 to -1), weeks 8, 12 and 24
The effect of Org 3236 on LUTS compared to placebo
Measured: Screening up to and including week 24
The effect of Org 3236 on urinary flow and postvoid residual volume compared to placebo
Measured: Screening and weeks 2 - 24
The effect on progression of LUTS
Measured: Screening up to and including week 24
The effect of Org 3236 on sexual function; well-being and LUTS-related Quality of Life compared to placebo
Measured: Screening and weeks 4 - 24; screening and weeks 2 - 24, respectively
The safety of Org 3236
Measured: Screening up to and including week 24
The pharmacokinetic (Org 3236) and pharmacodynamic (T, DHT, LH, FSH, E2, SHBG) properties
Measured: Randomization and weeks 2 - 8; randomization and weeks 2 - 12 and 24, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: Business Reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651807
- Sponsor's protocol ID
- P05806
- Other IDs
- 304001
- Status last verified
- Feb 2022
- First submitted
- 31 Mar 2008
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1016/j.eururo.2004.07.016.
PubMed 15474261Gonzalez 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.
PubMed 12882718McConnell 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00651807
- Acronym / sponsor ID
- P05806
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Reasons
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 3 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: etonogestreletonogestrel |
| Arm 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etonogestrelAlso: Org 3236Lowest dose of Org 3236 per two days, lowest dose of Org 3236 per day, highest dose of Org 3236 per day for 8 weeks | Drug | Arm 1 |
| PlaceboEvery day one tablet up to 8 weeks | Drug | Arm 2 |
Primary outcome
The effect of Org 3236 on prostate volume compared to placebo
Time frame: Screening (days -30 to -1), weeks 8, 12 and 24
The effect of Org 3236 on LUTS compared to placebo
Time frame: Screening up to and including week 24
The effect of Org 3236 on urinary flow and postvoid residual volume compared to placebo
Time frame: Screening and weeks 2 - 24
The effect on progression of LUTS
Time frame: Screening up to and including week 24
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
The safety of Org 3236
Time frame: Screening up to and including week 24
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
Results and safety
The study was stopped early (reason given: Business Reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 15474261Madersbacher 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.
- Background: PubMed 12882718Gonzalez 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.
- BackgroundMcConnell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing etonogestrel in people with Benign Prostatic Hyperplasia (BPH), run by Organon and Co at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business Reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of Org 3236 on prostate volume compared to placebo (time frame: Screening (days -30 to -1), weeks 8, 12 and 24). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00651807, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.