D004 (Palmex) vs Saw palmetto, Finasteride and Tamsulosin in patients with BPH

Comparative study of medium-term effects of Palmex (D-004), Saw palmetto,Finasteride and Tamsulosin in patients with Benign prostatic hyperplasia - D4SFTHPB

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000373

Enrollment

200

Registered

2021-05-27

Start date

2021-09-01

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia BPH

Interventions

Experimental Group 1, Palmex (320 mg): 1 softgel capsules daily, by oral route, before bedtimefor 6 months. Control Group: Saw palmetto (320 mg): 1 softgel capsule daily, by oral route, before bedtim

Dietary Supplements

Plant Extracts

Sabal serrulatum

Finasteride

Tamsulosin

Capsules

Tablets

Administration, Oral

Palmex

Eligibility

Sex/Gender

Male

Age

40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Those patients who meet the recruitment criteria (men = 40 years of age who have signed the informed consent and with mild or moderate lower urinary tract symptoms (LUTS). IPSS = 1, <19-) and with prostate enlargement verified by digital rectal examination.

Exclusion criteria

Exclusion criteria: Patients with Prostate cancer. Previous history of urological surgery (prostate, bladder or urethral). Urinary retention. Prostate antigen (PSA) values> 4 ng / mL. Presence of the middle lobe when performing transrectal ultrasound History of liver failure. History of chronic kidney failure. Blood pressure> 180/110 mmHg. Other active diagnosed neoplasms. Alcoholism. Psychiatric problems that limit the IPSS response. Treatment with ADR-a1 antagonists, 5 a-reductase inhibitors, androgens, antiandrogens, cholinergics, anticholinergics, steroids and /or phytotherapeutic treatments in the 6 months prior to the study. Usual clinical history of allergy to medications or any other special condition that, in the opinion of the doctor, puts your health and life at risk during the study

Design outcomes

Primary

Measure	Time frame
Maximum urinary flow (mL/s) (Improvement of the values of the maximum urinary flow at the end of the treatment with respect to the initial values, evaluated by uroflowmetry). Measurement time: At baseline and, 6 months.	—

Secondary

Measure	Time frame
1. IPSS scale (Significant reduction of the values of the IPSS scale at the end of the treatment with respect to the initial values). Measurement time: At baseline and, 2, 4 and 6 months of treatment. 2. Size of the prostate (mm) (Reduction of the size of the prostate with respect to the baseline value evaluated by transrectal ultrasound). Measurement time: At baseline and, 6 months of treatment. 3. Residual volume (mL) (Reduction of residual volume with respect to baseline value evaluated by transrectal ultrasonography). Measurement time: At baseline and, 6 months of treatment.	—

Measure

Time frame

1. IPSS scale (Significant reduction of the values of the IPSS scale at the end of the treatment with respect to the initial values). Measurement time: At baseline and, 2, 4 and 6 months of treatment. 2. Size of the prostate (mm) (Reduction of the size of the prostate with respect to the baseline value evaluated by transrectal ultrasound). Measurement time: At baseline and, 6 months of treatment. 3. Residual volume (mL) (Reduction of residual volume with respect to baseline value evaluated by transrectal ultrasonography). Measurement time: At baseline and, 6 months of treatment.

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Countries

Cuba

Contacts

Public ContactJulio Fernandez Travieso

Clinical Trails Unit, National Centre for Scientific Research

julio.fernandez@cnic.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Apr 4, 2026