Clinical Studies

Flomentum®is made withUSPlus® (Valensa), a clinically studied saw palmetto extract. Belowyou’llfind published research spanning benign prostatic hyperplasia (BPH) and urinary symptom support, along with studies exploring sexual health outcomes andadditionalareas of interest, including topical applications. Together, these clinical and comparative studies help show whereUSPlus® has been evaluated and how it relates to the European reference extract (Permixon®) used in many published trials.

Clinical Studies

Human Clinical Studies (HESr)

Canadian Journal of Urology (Can J Urol)

Measuring the efficacy of Serenoa repens (USPlus) extract with mobile uroflowmetry

Journal of Clinical & Investigative Dermatology (J Clin Investigat Dermatol)

Clinical Outcome of the Topical Application of a Novel Hair Growth Ingredient, USPlus DERM, in Men and Women

 

Mechanism / Comparability to the European Reference HESr

Uro (MDPI)

Lipid Profile and 5α-Reductase Inhibition Activity of Proprietary Ultrahigh-Pressure Supercritical CO₂ and Hexane Saw Palmetto Extracts

Nutraceutical Business Review

Valensa International announces newly published prostate health study

Nutraceuticals World

Preclinical study establishes mechanism of action of novel saw palmetto extract

 

Hexanic Extract of Serenoa repens (HESr)

Prostate

Permixon vs finasteride in BPH: randomized international study (n=1,098), 2 years

European Urology

Permixon vs tamsulosin: 1-year randomized international trial (equivalence)

European Urology

PERMAL subset (severe LUTS): Permixon slightly superior to tamsulosin at 3–12 months

Clinical Drug Investigation

Permixon vs placebo after exclusion of placebo responders; double-blind

British Journal of Clinical Pharmacology

Double-blind trial of S. repens extract in BPH (early randomized controlled pilot)

 

Combination/Adjunct Trials & Head-to-Head (Useful for Safety/Sexual AEs)

European Urology

Evaluation of male sexual function in the 1-year tamsulosin vs Permixon RCT cohort (n=704)

Journal of Clinical Medicine (MDPI)

Tamsulosin + HESr vs tamsulosin alone (paired-matched, 6 months)

Therapeutic Advances in Urology (PMC)

Real-world: TAM + HESr vs TAM + 5-ARI

 

Human Tissue / Mechanistic Clinical Studies

National Library of Medicine

3-month treatment: intraprostatic DHT↓, T↑ with Permixon (biopsy-verified 5α-reductase inhibition in vivo)

European Urology

Healthy volunteers, finasteride vs Permixon vs placebo: serum DHT effects over 1 week

 

Systematic Reviews & Meta-Analyses Focused on Permixon/HESr

BJU International

HESr (Permixon) for LUTS/BPH: systematic review & meta-analysis of RCTs + observational

European Urology Focus (ScienceDirect)

Efficacy and Safety of Hexanic Lipidosterolic Extract of Serenoa repens

Urology (Gold Journal)

Meta-analysis of Permixon clinical trials

Clinical Drug Investigation (PMC)

Hexanic Extract of S. repens (Permixon): Review in LUTS/BPH

 

EMA Basis for “Clinical Strength = 320 mg” and EU Recognition

EMA/HMPC

“Well-Established Use” Monograph – Serenoa repens fructus, hexane soft extract (DER 7–11:1)

European Medicines Agency (EMA)

Sabalis serrulatae fructus (herbal medicine page)

 

Support for “Sexual Side-Effects Similar to Placebo”

European Urology

Permixon vs tamsulosin: 1-year randomized international trial (equivalence)

European Urology

Evaluation of Male Sexual Function in Patients with Lower Urinary Tract Symptoms

ScienceDirect

Meta-analyses focused on HESr (Permixon) note minimal impact on sexual function compared with α-blockers/5-ARIs