Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Cyclopentanohydrophenanthrene ring system doai
Reexamination Certificate
2001-01-09
2002-05-21
Spivack, Phyllis G. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Cyclopentanohydrophenanthrene ring system doai
Reexamination Certificate
active
06391868
ABSTRACT:
FIELD OF THE INVENTION
This invention involves the administration of the natural androgen metabolite 5alpha-androst-1-en-3,17-dione(1-androstenedione) to produce an androgenic and anabolic response in humans. 1-androstenedione behaves as a prohormone in vivo, and converts to the active hormone 17beta-hydroxy-5alpha-androst-1-en-3-one.
DESCRIPTION OF THE PRIOR ART
U.S. Pat. No. 5,880,117 to Arnold discloses a method of effectively increasing testosterone levels in humans by the administration of the testosterone precursor 4-androstenediol. Similarly, U.S. Pat. No. 6,011,027 to Arnold discloses a method for increasing nortestosterone levels in humans by administration of the nortestosterone metabolic precursor 19-nor-4-androstenediol. In addition to these two patents, U.S. Pat. No. 5,578,588 to Mattern and Hacker also discloses the usage of 4-androstenedione as a metabolic precursor to increase levels of testosterone in humans. The pharmacokinetics of the oral administration of such metabolic precursors is such that a peak in hormone levels in the blood is seen at approximately 90 minutes with a subsequent decline to baseline levels within 3-4 hours. This fact permits one to more closely simulate the natural endogenous pulsatile release of testosterone through multiple daily dosing of androgenic precursors. This should result in a more normal physiological response with a minimization of side effects and HPTA shutdown. Furthermore, since these precursors are not 17alpha alkylated compounds, their hepatotoxicity is minimal.
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Berns Michael
LPT Research, Inc.
Maloney Parkinson & Berns
Spivack Phyllis G.
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