DHEA and SERM Combination for Male Androgen Deficiency
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Solution Overview
Problem
Current treatments for male hypogonadism and low testosterone levels are inadequate, as they often fail to address the underlying issue of low peripheral androgen formation, leading to persistent symptoms and potential adverse effects such as cardiovascular events and infertility.
Innovation Solution
Administering a sex steroid precursor, such as dehydroepiandrosterone (DHEA), in combination with a selective estrogen receptor modulator (SERM) like acolbifene, to stimulate local androgen production and increase testosterone levels, thereby addressing the root cause of hypogonadism symptoms while minimizing side effects.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If traditional testosterone therapy is used to treat male hypogonadism, then testosterone levels are increased, but adverse effects on prostate volume and cardiovascular risk occur
Solution Approach 1:
The patent changes the chemical parameters by using DHEA (dehydroepiandrosterone) instead of traditional testosterone replacement. DHEA is a precursor that converts to androstenedione and testosterone locally in peripheral tissues, achieving the desired testosterone increase while avoiding the harmful effects of exogenous testosterone on the prostate and cardiovascular system
Solution Approach 2:
The patent introduces DHEA as an intermediary substance that acts as a precursor to testosterone. Rather than directly administering testosterone, DHEA serves as a mediator that converts to active androgens locally in target tissues, thereby achieving therapeutic effects without the direct adverse effects of testosterone replacement
2Reliability
If testosterone replacement therapy is administered, then hypogonadism symptoms are improved, but infertility occurs
Solution Approach 1:
The patent changes the approach from exogenous testosterone replacement to DHEA supplementation. This parameter change allows the body to maintain its own testosterone production through local conversion in peripheral tissues, thereby improving hypogonadism symptoms while preserving fertility by avoiding suppression of endogenous testicular function
3Reliability
If peripheral androgen formation is low, then hypogonadism symptoms occur, but traditional therapy does not address the root cause
Solution Approach 1:
The patent extracts the root cause of hypogonadism by identifying low peripheral androgen formation from DHEA as the underlying problem. Instead of merely replacing testosterone, the treatment extracts and addresses the precursor deficiency, thereby resolving the root cause rather than just the symptoms
Solution Approach 2:
The patent applies preliminary action by supplementing DHEA, the precursor substance, before it can be converted to testosterone in peripheral tissues. This preliminary supplementation ensures adequate substrate availability for local androgen formation, thereby addressing the root cause of reduced peripheral androgen production
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach effectively reduces or eliminates symptoms of hypogonadism, improves muscle mass and strength, bone density, and metabolic parameters, while avoiding the adverse effects on prostate volume and cardiovascular risk associated with traditional testosterone therapy.
Implementation Method 1
a sex steroid precursor, such as dehydroepiandrosterone (DHEA), in combination with a selective estrogen receptor modulator (SERM) like acolbifene, to stimulate local androgen production
Implementation Method 2
selective estrogen receptor modulator (SERM) like acolbifene, to stimulate local androgen production
Data Source
AI summary
Novel methods for prevention, reduction or elimination of the incidence of male androgen deficiency symptoms or diseases including male hypogonadism-associated symptoms and diseases associated with low serum testosterone and/or low DHEA or low total androgens in susceptible warm-blooded animals including humans involving administration of an amount of a sex steroid precursor, particularly dehydroepiandrosterone (DHEA) and a selective estrogen receptor modulator (SERM) (particularly acolbifene), an antiestrogen or a prodrug of the two. The symptoms or diseases are loss of libido, erectile dysfunction, tiredness, loss of energy, depression, bone loss, muscle loss, muscle weakness, fat accumulation, memory loss, cognition loss, Alzheimer's disease, dementia, loss of body hair, fertility problems, insomnia, gynecomastia, anemia, hot flushes, sweats, decreased sense of well-being, obesity, osteoporosis, hypercholesterolemia, hyperlipidemia, atherosclerosis, hypertension, insulin resistance, cardiovascular disease and type 2 diabetes. Pharmaceutical compositions for delivery of active ingredient(s) and kit(s) useful to the invention are also disclosed.