MensHealthSolutions.wikiThe Men’s Health Solutions Reference

Treatments and FDA labeling

From MensHealthSolutions.wiki, a sourced reference on Men’s Health Solutions in Indianapolis

By the Men's Health Solutions Wiki editorial team · Published · Last updated

Short answer: Testosterone products are FDA-approved only for men with low testosterone caused by a diagnosed medical condition, and they are Schedule III controlled substances.[1][2] Sildenafil and tadalafil are FDA-approved for erectile dysfunction and must not be used with nitrates.[3][4] Compounded drugs, including compounded peptides, are not FDA-approved.[5] This page summarizes labeling; it is not medical advice.

Disclosure: MensHealthSolutions.wiki is a reference compiled from public records. It is not the official website of Men’s Health Solutions; it is produced by a marketing agency that works for Men’s Health Solutions. It is not written or reviewed by the Medical Licensing Board of Indiana, the Indiana Professional Licensing Agency, the U.S. Food and Drug Administration or any other regulator. Facts are cited to government records, FDA drug labeling and the clinic’s own website; verify anything important, such as a clinician’s license, the services offered or costs, directly with the clinic and the state. This site does not give medical advice; talk to a licensed clinician about any treatment, and in an emergency call 911. See the editorial policy.

Why does this page exist?

Men’s Health Solutions names testosterone therapy, sildenafil, tadalafil, vardenafil, injectable ED medicines and peptides on its website.[6][7][8] This page sets out what official U.S. drug labeling and FDA guidance say about those kinds of products, so readers can compare. It does not say what the clinic prescribes, which product suits anyone, or how well any of them work. Only a licensed clinician who knows your medical history can advise on treatment.

What does FDA labeling say about testosterone?

  • Approved use. The FDA says testosterone is “approved solely for use in men who lack or have low testosterone levels in conjunction with an associated medical condition”.[1] The Depo-Testosterone (testosterone cypionate) label lists primary hypogonadism and hypogonadotropic hypogonadism, and says safety and efficacy in “age-related hypogonadism” have not been established.[2]
  • Controlled substance. The label identifies testosterone as a Schedule III controlled substance and describes abuse and misuse risks.[2]
  • Contraindications. The label lists men with breast cancer or known or suspected prostate cancer, women who are pregnant, and patients with serious heart, liver or kidney disease.[2]
  • Blood pressure and heart. In February 2025 the FDA told makers to add results of the TRAVERSE trial, which it said found no increase in adverse cardiovascular outcomes in men using testosterone for hypogonadism; to remove boxed-warning language about cardiovascular risk; to keep the limitation of use for age-related hypogonadism; and to add or update warnings on increased blood pressure.[1] The cypionate label says testosterone “can increase blood pressure which can increase cardiovascular (CV) risk over time”.[2]
  • Monitoring and other warnings. The label says hemoglobin and hematocrit should be checked periodically during long-term use, reports venous blood clots (deep vein thrombosis and pulmonary embolism), and says that at large doses sperm production may be suppressed.[2]

What does FDA labeling say about ED pills?

Sildenafil (Viagra) and tadalafil (Cialis) are phosphodiesterase-5 (PDE5) inhibitors approved to treat erectile dysfunction; tadalafil is also approved for symptoms of benign prostatic hyperplasia.[3][4] Both labels say:

  • they must not be taken with nitrates in any form, or with guanylate cyclase stimulators such as riociguat;[3][4]
  • an erection lasting more than four hours needs emergency treatment;[3]
  • patients should stop and seek care for sudden loss of vision (a possible sign of NAION) or sudden loss of hearing.[3]

What about injected ED medicines?

Alprostadil injected into the penis (Caverject) is FDA-approved for erectile dysfunction. Its label says the first injections should be given in a health care provider’s office, and lists contraindications including conditions that predispose to priapism, such as sickle cell disease, and penile implants.[9] Mixed injections such as “trimix” (alprostadil, phentolamine and papaverine), which a clinic blog post describes,[10] are compounded products. The FDA says compounded drugs “are not FDA-approved”, meaning it does not verify their safety, effectiveness or quality before they are marketed.[5]

What does the FDA say about compounded peptides?

The clinic’s peptide page does not name the peptides it uses.[8] In general, the FDA says compounded drugs are not FDA-approved and should only be used for patients whose needs cannot be met by an approved drug.[5] The FDA also keeps a list of bulk substances it says “may present significant safety risks” in compounding; it includes several growth-hormone-releasing peptides, such as GHRP-2, GHRP-6 and ipamorelin acetate, and lists others, such as BPC-157 and CJC-1295, whose nominations were withdrawn.[11] This site has no information that the clinic uses any of these substances; the list is included so readers can ask informed questions.

Frequently asked questions

Is testosterone FDA-approved for low testosterone due to aging?

FDA labeling says safety and efficacy in age-related hypogonadism have not been established, and the FDA kept that limitation of use in its 2025 labeling changes.

Is testosterone a controlled substance?

Yes. FDA labeling identifies testosterone as a Schedule III controlled substance.

Can sildenafil or tadalafil be taken with nitrates?

No. Both labels list use with nitrates in any form as a contraindication.

Are compounded peptides FDA-approved?

No. The FDA says compounded drugs are not FDA-approved and that it does not verify their safety, effectiveness or quality before marketing.

See also

References

  1. ^ a b c "FDA issues class-wide labeling changes for testosterone products" (28 February 2025). U.S. Food and Drug Administration. Retrieved 2 October 2026.
  2. ^ a b c d e f "Depo-Testosterone (testosterone cypionate) injection", prescribing information (DailyMed version published 20 August 2026). Pharmacia & Upjohn Company LLC, via DailyMed (U.S. National Library of Medicine). Retrieved 2 October 2026.
  3. ^ a b c d e "Viagra (sildenafil citrate) tablets", prescribing information (DailyMed version published 13 February 2026). Pfizer, via DailyMed (U.S. National Library of Medicine). Retrieved 2 October 2026.
  4. ^ a b c "Cialis (tadalafil) tablets", prescribing information (DailyMed version published 10 June 2026). Eli Lilly and Company, via DailyMed (U.S. National Library of Medicine). Retrieved 2 October 2026.
  5. ^ a b c "Compounding and the FDA: Questions and Answers". U.S. Food and Drug Administration. Retrieved 2 October 2026.
  6. ^ "Testosterone Therapy (TRT) Indianapolis". Men's Health Solutions (menshealthsolutions.us). Retrieved 2 October 2026.
  7. ^ "Erectile Dysfunction Treatment in Indianapolis, IN". Men's Health Solutions (menshealthsolutions.us). Retrieved 2 October 2026.
  8. ^ a b "Peptide Therapy in Indianapolis". Men's Health Solutions (menshealthsolutions.us). Retrieved 2 October 2026.
  9. ^ "Caverject (alprostadil) injection", prescribing information (DailyMed version published 17 May 2024). Pharmacia & Upjohn Company LLC, via DailyMed (U.S. National Library of Medicine). Retrieved 2 October 2026.
  10. ^ "Modern Treatment Options for ED: Beyond the Blue Pill" (blog, December 2024). Men's Health Solutions (menshealthsolutions.us). Retrieved 2 October 2026.
  11. ^ "Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks". U.S. Food and Drug Administration. Retrieved 2 October 2026.