Benign prostatic hyperplasia MedDRA version: 9.1 Level: LLT Classification code 10004446 Term: Benign prostatic hyperplasia
Conditions
Interventions
Product Name: etonogestrel
Product Code: Org 3236
Pharmaceutical Form: Tablet
INN or Proposed INN: etonogestrel
CAS Number: 54048-10-1
Current Sponsor code: Org 3236
Concentration unit: µg microgram(s
Sponsors
NV Organon
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent, obtained before screening evaluations; 2. Men diagnosed with LUTS suggestive of BPH: 2.1. Baseline IPSS score of = 12 (moderate to severe); 2.2. Prostate volume of = 40 mL and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 5. A postvoid residual volume >250 mL; 6. Use of anti-androgens, androgens, Gonadotropin Releasing Hormone (GnRH) antagonists, or 5a-reductase inhibitors within six months prior to start trial medication; 7. Use of a-blockers, phytotherapy (for LUTS) or drugs interfering with bladder function within two weeks prior to start trial medication; 8. Presence of hypogonadism as judged by the (sub)investigator; 9. Acute urinary retention within the past 12 months; 10. History of surgery for BPH, including other minimally invasive procedures; 11. Presence of urinary tract infection; 12. Presence or history of (subclinical) prostate cancer, bladder cancer, urethral stricture, or pelvic irradiation; 13. Presence or history (within the past 12 months) of depression or other psychiatric disease of moderate or severe intensity; 14. Cardiac or cerebrovascular event within the past six months; 15. Presence or history of any neurological disease associated with primary bladder dysfunction; 16. Presence or history of liver disease or disturbance of liver function that failed to return to normal; 17. Presence or history of renal disease or disturbance of renal function that failed to return to normal; 18. Present use or use within two months prior to screening of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, hydantoins, rifampicin, ritonavir, nelfinavir, and griseofulvin; 19. Presence or history (within the past 12 months) of alcohol or drug abuse as judged by the (sub)investigator; 20. Clinically relevant abnormal laboratory result as judged by the (sub)investigator; 21. Known hypersensitivity to any of the components of trial medication; 22. Administration of investigational drugs and/or participation in another clinical trial within two months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • 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 Objective: ;Primary end point(s): - Prostate volume - Effect on lower urinary tract symptoms - Urinary flow rate - Postvoid residual volume - Progression of lower urinary tract symptoms - Sexual functioning, well-being and Quality of life - Pharmacokinetics and pharmacodynamics of Org 3236 - Safety of Org 3236 | — |
Countries
Netherlands, Poland, United Kingdom
Outcome results
None listed