TEFINA™

TEFINA™ is a “use as required”, low-dose nasal testosterone gel treatment in development for female sexual dysfunction. It is the first product to show efficacy results in a large Phase II study.


Female Sexual Dysfunction & Testosterone Replacement Therapy

Female sexual dysfunction consists of three recognized disorders: sexual interest/arousal disorder, genito-pelvic pain/penetration disorder (painful sexual intercourse) and female orgasmic disorder. Specifically, female orgasmic disorder (also referred to as ‘anorgasmia’) is characterized by a persistent difficulty experiencing orgasm and/or markedly reduced intensity of orgasmic sensations.1

Reported prevalence rates for female orgasmic problems in women vary widely, from 10% to 42%, depending on multiple factors (e.g., age, culture, duration, and severity of symptoms).2 In a survey of over 1,700 women aged 18 to 59, 43% acknowledged some form of sexual dysfunction. The data suggested that 32% of the women lacked interest in sex and 26% could not experience orgasm.3

Testosterone is the primary circulating androgen in women and is a naturally occurring steroid secreted by the ovaries and the adrenal glands. Contrary to the sudden drop in estrogen during menopause, serum levels of androgens fall gradually as women age primarily due to a decrease in the production of adrenal androgen precursors. Testosterone plays a role in mood, body composition, bone mineral density and has central and peripheral effects on sexual function. Over the two past decades, over 80 studies have been conducted in women with female sexual dysfunction using exogenous testosterone through the oral, transdermal, sublingual or parental (injection) route of administration with or without concomitant estrogen therapy, resulting in an increase in sexual desire, arousal, frequency of satisfactory sexual activity, pleasure and responsiveness. At present, no pharmacologic therapies are approved in the U.S or Canada for the treatment of female orgasmic disorder.

For further information, please click on the link below to access the trial summary (Clinicaltrials.gov):

Efficacy and Safety of TBS-2 Testosterone Gel in Women with Acquired Female Orgasmic Disorder

References:

  1. American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders: DSM-5 (5th ed.). Arlington, VA: American Psychiatric Publishing, pp 430.
  2. Ibid, pp 431.
  3. Laumann et al. Sexual dysfunction in the United States: Prevalence and predictors. Journal of the American Medical Association. April 1999.