Our Commitment to Science
Our treatments at WellMensRX are supported by peer-reviewed clinical research. We believe in complete transparency about the science behind our formulations, providing you with access to the same studies our medical team uses when developing treatment protocols.
Our approach is evidence-based: no hype, just data. The citations provided on this page represent a curated selection of the most relevant research supporting the safety and efficacy of our treatment compounds.
All medications prescribed through WellMensRX are FDA-approved compounds or compounded formulations prepared by state-licensed pharmacies. Our treatment protocols are developed in accordance with current clinical guidelines and peer-reviewed research.
Tadalafil Research
Tadalafil, the active ingredient in Cialis, is one of the most extensively studied medications for erectile dysfunction. Its unique 36-hour duration of action has made it a preferred choice for men seeking spontaneity in their intimate lives.
2.1 Efficacy and Safety Profile
Integrated analyses of clinical trials demonstrate that tadalafil significantly improves erectile function across diverse patient populations, including those with diabetes and post-prostatectomy patients.
| Study | Authors | Journal | Key Finding |
|---|---|---|---|
| Efficacy and safety of tadalafil: integrated analyses | Brock GB et al. | J Urol, 2002 | Significant improvement in erectile function vs placebo |
| Long-term safety of tadalafil 5mg daily | Porst H et al. | Int J Impot Res, 2014 | Well-tolerated over extended treatment periods |
| Tadalafil efficacy update | Carson CC et al. | Urology, 2003 | Consistent efficacy across multiple trials |
| Male Sexual Dysfunction Guidelines | Hatzimouratidis K et al. | Eur Urol, 2010 | First-line treatment recommendation |
| Tadalafil pharmacokinetics | Forgue ST et al. | Br J Clin Pharmacol, 2006 | 17.5-hour half-life enabling 36-hour window |
| Endothelial function improvement | Rosano GM et al. | Eur Heart J, 2005 | Cardiovascular benefits in at-risk patients |
2.2 Cardiovascular Considerations
Research indicates that chronic tadalafil treatment may improve endothelial function in men with increased cardiovascular risk, suggesting potential benefits beyond erectile function alone.
PT-141 (Bremelanotide) Research
PT-141 (Bremelanotide) represents a novel approach to sexual dysfunction treatment. Unlike PDE5 inhibitors that work on blood flow, PT-141 activates melanocortin receptors in the brain to enhance sexual desire at its neurological source.
3.1 Mechanism of Action
Bremelanotide works centrally through the melanocortin system, specifically targeting MC3R and MC4R receptors in the hypothalamus. This unique mechanism addresses the psychological and neurological components of sexual desire.
| Study | Authors | Journal | Key Finding |
|---|---|---|---|
| Bremelanotide for HSDD treatment | Kingsberg SA et al. | Obstet Gynecol, 2019 | Significant increase in sexual desire and arousal |
| Mechanism of action in HSDD | Clayton AH et al. | J Clin Psychiatry, 2022 | Central nervous system pathway activation |
| Effects on desire and arousal | Rosen RC et al. | CNS Spectr, 2019 | Measurable improvements in desire metrics |
| Erectile function trial | Wessells H et al. | Ann Intern Med, 2007 | Efficacy in men with erectile dysfunction |
Bremelanotide (Vyleesi) received FDA approval in 2019 for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women, with ongoing research into applications for male sexual dysfunction.
Note: PT-141 (Bremelanotide) is FDA-approved under the brand name Vyleesi® for hypoactive sexual desire disorder in premenopausal women. Use in men is considered off-label. Off-label prescribing is a legal and common medical practice when a provider determines it may benefit a patient.
Testosterone & Male Vitality Research
Testosterone plays a fundamental role in male sexual function, energy levels, and overall well-being. Research from the Massachusetts Male Aging Study and subsequent investigations has established clear links between testosterone levels and sexual health outcomes.
4.1 Prevalence and Impact
Studies indicate that erectile dysfunction affects approximately 52% of men between ages 40-70, with testosterone deficiency being a significant contributing factor in many cases.
| Study | Authors | Journal | Key Finding |
|---|---|---|---|
| Sexual dysfunction prevalence consensus | McCabe MP et al. | J Sex Med, 2016 | Global prevalence data and risk factors |
| Massachusetts Male Aging Study | Feldman HA et al. | J Urol, 1994 | 52% prevalence in men 40-70 years |
| Libido and testosterone relationship | Travison TG et al. | J Clin Endocrinol Metab, 2006 | Direct correlation between T levels and desire |
| Testosterone and metabolic syndrome | Corona G et al. | Nat Rev Urol, 2011 | Bidirectional relationship established |
| Testosterone treatment in older men | Snyder PJ et al. | N Engl J Med, 2016 | Improvements in sexual function and mood |
4.2 Treatment Outcomes
The Testosterone Trials (TTrials) demonstrated that testosterone treatment in older men with low testosterone improved sexual function, physical function, and vitality compared to placebo.
Combination Therapy Research
Emerging research supports the use of combination therapies for enhanced efficacy in treating erectile dysfunction and related conditions. Multi-modal approaches may address multiple pathways simultaneously.
5.1 Synergistic Effects
A systematic review and meta-analysis published in JAMA Network Open found that combination therapies demonstrated superior outcomes compared to monotherapy in many patient populations.
| Study | Authors | Journal | Key Finding |
|---|---|---|---|
| Combination vs monotherapy meta-analysis | Mykoniatis I et al. | JAMA Netw Open, 2021 | Superior outcomes with combination therapy |
| Shockwave therapy plus tadalafil | Li H et al. | Aging Male, 2020 | Enhanced results in diabetic patients |
| Sublingual apomorphine for ED | Hedon F | Expert Opin Pharmacother, 2002 | Central-acting mechanism complements PDE5i |
| Oxytocin effects on sexual experiences | Behnia B et al. | Horm Behav, 2014 | Enhanced intimacy and satisfaction |
| Intranasal oxytocin safety review | MacDonald E et al. | Psychoneuroendocrinology, 2011 | Favorable safety profile established |
Long-Term Safety Data
Long-term safety studies are essential for treatments used on an ongoing basis. The medications we prescribe have been evaluated in extended trials lasting up to 2 years or more.
6.1 Cardiovascular Safety
Research suggests that PDE5 inhibitors do not significantly increase cardiovascular risk in appropriate patient populations when used as directed, and may potentially support cardiovascular health through improved endothelial function.
| Study | Authors | Journal | Key Finding |
|---|---|---|---|
| Long-term tadalafil safety | Montorsi F et al. | Eur Urol, 2004 | Well-tolerated with consistent efficacy |
| Tadalafil with antihypertensives | Kloner RA et al. | Am J Cardiol, 2003 | No significant drug interactions |
| Vardenafil 2-year tolerability | Hellstrom WJ et al. | Int J Impot Res, 2003 | Sustained efficacy without tolerance |
PDE5 inhibitors are contraindicated in patients taking nitrates. Always disclose all medications to your healthcare provider before starting treatment.
Medical Disclaimer
7.1 Educational Purpose
The citations and research summaries provided on this page are for educational and transparency purposes only. This content does not constitute medical advice and should not replace consultation with a licensed healthcare provider.
7.2 Individual Variation
Clinical data reflects population averages. Your individual response to treatment will depend on your health status, adherence to prescribed protocols, and individual biology. Results may vary.
7.3 Physician Evaluation Required
A licensed physician must evaluate your eligibility for treatment based on:
- Your complete medical history
- Current prescription medications
- Known risk factors and contraindications
- Individual treatment goals
These statements have not been evaluated by the Food and Drug Administration. Compounded medications are not FDA-approved and have not been evaluated for safety and effectiveness by the FDA. Compounded medications are prepared by state-licensed pharmacies in accordance with applicable regulations.
Full References
Complete citations for all studies referenced on this page:
The studies cited may have limitations including sample size, study design, or population studied. Results from clinical trials may not be representative of outcomes in all individuals. We encourage you to discuss research findings with your healthcare provider.
- Brock GB et al. Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses. J Urol. 2002;149(5). doi:10.1016/S0022-5347(05)65751-3
- Porst H et al. Long-term safety and efficacy of tadalafil 5 mg dosed once daily in men with erectile dysfunction. Int J Impot Res. 2014;26(6). doi:10.1038/ijir.2014.14
- Carson CC et al. The efficacy and safety of tadalafil: an update. Urology. 2003;61(2). doi:10.1016/S0090-4295(02)02177-6
- Hatzimouratidis K et al. Guidelines on Male Sexual Dysfunction: Erectile dysfunction and premature ejaculation. Eur Urol. 2010;57(5). doi:10.1016/j.eururo.2010.02.020
- Forgue ST et al. Tadalafil pharmacokinetics in healthy subjects. Br J Clin Pharmacol. 2006;61(3). doi:10.1111/j.1365-2125.2005.02553.x
- Rosano GM et al. Chronic treatment with tadalafil improves endothelial function in men with increased cardiovascular risk. Eur Heart J. 2005;26(17). doi:10.1093/eurheartj/ehi346
- Kingsberg SA et al. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder. Obstet Gynecol. 2019;134(5). doi:10.1097/AOG.0000000000003500
- Clayton AH et al. Mechanism of action of bremelanotide in hypoactive sexual desire disorder. J Clin Psychiatry. 2022;83(2). doi:10.4088/JCP.21r14104
- Rosen RC et al. Effects of bremelanotide on sexual desire and arousal. CNS Spectr. 2019;24(1). doi:10.1017/S1092852917000943
- Wessells H et al. Effect of bremelanotide on erectile function: randomized trial. Ann Intern Med. 2007;146(1). doi:10.7326/0003-4819-146-1-200701020-00004
- McCabe MP et al. Incidence and Prevalence of Sexual Dysfunction in Women and Men: A Consensus Statement. J Sex Med. 2016;13(2). doi:10.1016/j.jsxm.2015.12.034
- Feldman HA et al. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994;151(1). doi:10.1016/S0022-5347(17)34871-1
- Travison TG et al. The relationship between libido and testosterone levels in aging men. J Clin Endocrinol Metab. 2006;91(7). doi:10.1210/jc.2005-2508
- Corona G et al. Testosterone and Metabolic Syndrome: A Meta-Analysis Study. Nat Rev Urol. 2011;8(8). doi:10.1038/nrurol.2011.112
- Snyder PJ et al. Effects of Testosterone Treatment in Older Men. N Engl J Med. 2016;374(7). doi:10.1056/NEJMoa1506119
- Mykoniatis I et al. Assessment of Combination Therapies vs Monotherapy for Erectile Dysfunction: A Systematic Review and Meta-analysis. JAMA Netw Open. 2021;4(2). doi:10.1001/jamanetworkopen.2020.36337
- Li H et al. Low-intensity shockwave therapy plus tadalafil in men with type 2 diabetes and ED. Aging Male. 2020;23(5). doi:10.1080/13685538.2020.1765330
- Hedon F. Sublingual apomorphine for the treatment of erectile dysfunction. Expert Opin Pharmacother. 2002;3(2). doi:10.1517/14656566.3.2.177
- Behnia B et al. Differential effects of intranasal oxytocin on sexual experiences in couples. Horm Behav. 2014;65(3). doi:10.1016/j.yhbeh.2014.01.009
- MacDonald E et al. Safety, side-effects and subjective reactions to intranasal oxytocin: a review. Psychoneuroendocrinology. 2011;36(8). doi:10.1016/j.psyneuen.2011.02.015
- Montorsi F et al. Long-term safety and tolerability of tadalafil in the treatment of erectile dysfunction. Eur Urol. 2004;45(3). doi:10.1016/j.eururo.2003.11.010
- Kloner RA et al. Cardiovascular effects of tadalafil in patients on antihypertensive therapies. Am J Cardiol. 2003;92(9). doi:10.1016/S0002-9149(03)00829-2
- Hellstrom WJ et al. Sustained efficacy and tolerability of vardenafil over 2 years of treatment. Int J Impot Res. 2003;15(4). doi:10.1038/sj.ijir.3901013