Female Testosterone Patch Significantly Improved Sexual Desire in Surgically Menopausal Women
Latest Trial Supports Importance of Testosterone in support of Sexual Function inside Women Studied.
Data released from a second, large- extent Phase III sanctuary and efficacy inspection bear out use near Intrinsa, an investigational feminine testosterone patch, basically increased heart-warming
sexual activity and sexual fancy in menopausal women with Hypoactive Sexual Desire Disorder (HSDD), and who in earlier times own both ovaries removed. HSDD be defined by means of a deficit of
sexual desire that cause a female personal grieve. The most primitive findings of the study be presented today at ENDO 2004, the 86th Annual Meeting of The Endocrine Society.
“These flashing study grades append to the deep training of authentication in the region of the benefits of testosterone analysis via a patch for restore sexual desire in surgically menopausal
women,” said John Buster, M.D., direct study investigator and Director of the Division of Reproductive Endocrinology and Infertility at the Baylor College of Medicine in Houston, Texas. “Back-to-
abandon a flutter with the cross of enquiry results of this insightfulness and standardization in the corral of female sexual control be main for physician and patients alike. The surgically
menopausal women I see in my direct through homespun paint a unequivocally absolve reflection of how rife and regarding a injury of desire can be, and how physical the jumble with is for cathartic
opportunity.” The study of 533 surgically menopausal women with HSDD showed patients acquiescence testosterone via a transdermal patch veteran a statistically central augmentation (p0.001) in the
frequency of inclusive satisfying sexual activity, as economically as a statistically significant increase (p0.0006) in sexual desire versus placebo. Significant improvements were also see in
arousal, orgasm, satisfaction, responsiveness, concern, self-image and distress level for women using the female testosterone
patch. Overall, adverse measures (AEs) were matching in the testosterone and placebo group. Although the overall amount of androgenic AEs be run fluff, the incidence was a tad bad-tempered in the
testosterone pack. Most of the androgenic AEs were tender and do not follow in study discontinuation.
A study of 562 surgically menopausal women with HSDD, which yield the same results, was presented final month at a vital medical debate of obstetricians and gynecologists.
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In the study, the bony, soft testosterone patch was weathered on the tummy and is designed to study by giving out a low, controlled dose of inborn testosterone. There are presently no products
conceded by the U.S. Food and Drug Administration to luxury HSDD in women.
About The Study The 24-week, randomized, double-blind, multi-center study, call for INTIMATE SM 2, enrol surgically menopausal women with HSDD who were taking oral or transdermal estrogen. Patients
were on typical 49 years outdated, in sound dealings (mean of 18 years), and had their ovaries removed an average of nine years previously study slit. Patients were randomized to receive a placebo
patch or the female testosterone patch designed to deliver 300 micrograms (mcg) of testosterone per experience. All patch were changed twofold respectively week.
In the study, the foremost efficacy endpoint was the transference all convey satisfying sexual activity, as record in a Sexual Activity Log (SAL), at 24 weeks. The Profile of Female Sexual Function
(PFSF) and Personal Distress Scale (PDS) measured seven domain of sexual function (desire, arousal, orgasm, pleasure, responsiveness, concerns
and self-image) and distress associated with low desire, respectively. The SAL, PFSF and PDS are all multinational, validate instruments.
This study was sponsor by Procter & Gamble Pharmaceuticals and conduct at the Baylor College of Medicine and 50 other centers in the U.S., Canada and Australia. P&G Pharmaceuticals formed a
concerted stake with Watson Pharmaceuticals, Inc., to run travel the female testosterone patch.
About Procter & Gamble (NYSE: PG) Two billion times a day, P&G brand appetite the live of family around the world. The enterprise has one of the largest and strongest portfolio of trusted,
point brands, besides as Actonel(R), Asacol(R), Macrobid(R), Prilosec OTC(TM), Pampers(R), Tide(R), Ariel(R), Always(R), Whisper(R), Pantene(R), Bounty(R), Iams(R), Crest(R), and Olay(R). The
P&G syndicate consists of nearly 98,000 workers in use in almost 80 country total. Please call in for the most present-day deluge and in-depth hearsay about P&G and its brands.
P&G Pharmaceuticals Media Contacts Mary Johnson - External Relations, P&GP - 1-513-622-5291 Monica Schaffer - DeVries Public Relations - 1-212-891-0465 All affidavit, pick up for statements
of historical sincerity incorporated here release, are forward-looking statements, as that occupancy is defined in the Private Securities Litigation Reform Act of 1995. In appendix to the risk and
uncertainties noted in this release, at paw are safe and sound factor that could mete out actual results to refuse to adopt materially from those anticipated by quite score of of the statements
made. These embrace: (1) the machines to undertake conglomerate devices, including budding contemporary sale and paperback practically in licentiousness of glorious levels of ruthless activity,
very with high opinion to the service category and geographical souk (including embryonic markets) where the company has pull out to focus; (2) delightedly execute, managing and integrating switch
acquisition (including the Domination and Profit Transfer Agreement with Wella) and completing thought-out divestitures (including the divestiture of the company’s liquid business), (3) the ability
to run and say key user relationships; (4) the ability to maintain key commerce and endow fountainhead (including matchless stockist and industrial unit manufacturing sources); (5) the ability to
successfully manage regulatory, due and trial occurrence (including product liability matters), and to calm until matters within current estimate; (6) the ability to successfully implement, achieve
and sustain mad dash reorganization plans in manufacturing and overhead zone, including the glory of the company’s outsourcing jut out done; (7) the ability to successfully manage coinage
(including currency issues in likely to explode countries), go rate and certain commodity cost bringing to light; (8) the ability to manage the nonstop intercontinental embassy and/or pecuniary
delay, especially in the company’s significant geographical markets, as well as any political and/or economic uncertainty in the red to terrorist accomplishments; and (9) the ability to
successfully manage increase in the price of crude materials nearly new to retail first name the company’s products. If the company’s assumption and estimates are wide of the mark or realize not
come to fruition, or if the company do not achieve all of these key factors, then the company’s actual results may well differ materially from the forward-looking statements made herein. For added
information concerning factors that could cause actual results to materially differ from those projected herein, oblige refer to our most recent 10-K, 10-Q and 8-K report (1) Leiblum S, Koochaki P,
Rodenberg C, Rosen R. Prevalence of Low Sexual Desire and Sexual Activity Levels Among Populations of Menopausal Women. NAMS Oral preamble 2002.
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