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Hormone pill tested for prostate troubles – but trial halted early

NCT ID NCT00651807

Disease control Sponsor: Organon and Co Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested a hormone drug called etonogestrel (Org 3236) in 16 men with moderate to severe urinary symptoms from an enlarged prostate. The goal was to see if the drug could shrink the prostate, improve urine flow, and boost quality of life compared to a placebo. However, the study was terminated early, so the findings are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
etonogestrel (a hormone drug)
What this could lead to
If it works, this could point toward a new hormone-based treatment for enlarged prostate symptoms.
What could go wrong
This was a very small, early-phase trial that was terminated, so results are limited. The drug may not prove effective or safe in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

16 people

The number who actually took part.

Start date

Mar 2008

Finished

Aug 2008

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 80 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Benign prostatic hyperplasia (BPH)

Contacts and locations

Locations

  • Instituto Médico Especializado

    Buenos Aires, Hidalgo, 1405, Argentina

More trials for these conditions

Other studies related to the condition(s) this trial covers.