home > Procter & Gamble > news   First medically licensed treatment to help women rediscover their sexual desire Intrinsa▼ patch significantly improves sexual desire1,2 in women concerned by loss of sexual desire following early menopause induced by surgery   3 Apr 2007 , London : The first ever medically licensed treatment for women concerned by low sexual desire following early menopause induced by surgery* has been made available today in the UK. The female testosterone patch, called Intrinsa, is indicated for the treatment of low sexual desire which causes distress in women who have experienced an early menopause following hysterectomy involving the removal of their ovaries and are receiving oestrogen therapy. 3 It is specifically developed for women in this group who are distressed by low sexual desire. Treatments have been available for many years to men who experience sexual difficulties. Approximately one million women in the UK have been pushed into premature menopause as a direct result of surgery to remove their ovaries during hysterectomy for serious conditions such as heavy bleeding, fibrosis and pelvic pain. 4 This procedure leads to a decrease in testosterone 3,5,6,7 a naturally occurring hormone in women 8 that may be a key mediator of sexual desire. 9 Professor Janice Rymer from the Royal College of Obstetrics and Gynaecology comments "Following removal of the ovaries, levels of testosterone drop dramatically by around 50% causing a potentially distressing decrease in sexual desire for many women." Some women who have undergone the trauma of surgical menopause experience low sexual desire. Among surgically menopausal women who experience a loss of sexual desire, 10 approximately one third are distressed and are classified as having hypoactive sexual desire disorder (HSDD)**10 "It is very rarely mentioned that in young women testosterone levels are actually higher than oestrogen. Many of my surgical menopause patients tell me they feel sexually numb and are really concerned about their relationship", comments Mr Nick Panay, consultant gynaecologist and patron of The Daisy Network, a nationwide support group for women with premature menopause. "Intrinsa offers real medical hope to these women as studies showed that the patch increases sexual desire and satisfying sexual activity, while reducing associated distress." Clinical trials involving over 1,000 surgically menopausal women with low sexual desire and associated distress on concomitant oestrogen therapy, reported significantly increased sexual desire and satisfying sexual activity at six months with Intrinsa compared with placebo, as well as significantly decreased personal concern due to low sexual desire.1,2 Studies up to one year show Intrinsa is generally well tolerated; further long-term studies are ongoing. Intrinsa is a clear patch worn on the abdomen, applied twice a week, which delivers a low dose of testosterone (300 mcg/24 hours) and achieves serum testosterone concentrations compatible with premenopausal levels. The testosterone used in the patch is identical to the testosterone produced naturally in all women.3 Patients can find further information about premature menopause at www.desireandmenopause.co.uk or contact The Daisy Network at www.daisynetwork.org.uk For further information please contact: Jemima Warrack / Gareth Field Ketchum +44 (0) 20 7611 3635 / +44 (0) 20 7611 3668 Dr Mark Chakravarty Procter & Gamble Pharmaceuticals +41 (22) 709 66 78 Notes to Editor: * Intrinsa is indicated for the treatment of hypoactive sexual desire disorder in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant oestrogen therapy. Oestrogen treatment is a standard therapy for surgically menopausal women.3 Current product information recommends Intrinsa for women up to the age of 60, as there are limited treatment data in women with surgical menopause over this age. Intrinsa is not recommended for women using oral conjugated equine oestrogen (CEE), as efficacy has not been demonstrated. Intrinsa treatment response should be evaluated within 3-6 months of initiation, to determine if continued therapy is appropriate. Continued use of Intrinsa is only recommended while concomitant use of estrogen is considered appropriate. ** Hypoactive sexual desire disorder is the medical term referred to by professional guidelines and the World Health Organisation classification for the persistent or recurrent deficiency and/or absence of sexual thoughts/fantasies, thoughts and/or receptivity to sexual activity which causes distress or interpersonal difficulty. 12, 13 Intrinsa (transdermal testosterone patch 300mcg/24 hours) was granted a marketing authorization valid throughout the European Union on 28 July 2006 by the European Commission.14 About Procter & Gamble Pharmaceuticals: Procter & Gamble has a rich heritage in health care that extends back more than 150 years. Then and now, P&G is driven by our mission to improve the lives of people around the world every day. P&G's health care products include prescription medicines, over-the-counter medications and oral care products. P&G began developing and marketing prescription products in the late-1960s. Three billion times a day, P&G brands touch the lives of people around the world. The company has one of the strongest portfolios of trusted, quality, leadership brands, including Actonel®, Asacol®, Vicks®, Pepto-bismol®, Metamucil®, Thermacare®, Crest®, Oral-B®, Tampax®, Always®, Pampers®, Ariel®, Fairy®, Iams®, Eukanuba®, Olay®, Head & Shoulders®, Wella and Gillette®. The P&G community consists of over 135,000 employees working in over 80 countries worldwide. Please visit www.pg.com for the latest news and in-depth information about P&G and its brands. For more information about P&G Pharmaceuticals, please visit www.pgpharma.com References 1 Simon J et al. Testosterone patch increases sexual activity and desire in surgically menopausal women with hypoactive sexual desire disorder. J Clin Endocrinol Metab. 2005; 90: 5226-5233 2 Buster JE et al . Testosterone patch for low sexual desire in surgically menopausal women: a randomised trial. Obstet Gynecol. 2005; 105: 944-95 3 Intrinsa Summary of Product Characteristics. August 2006. www.emea.europa.eu/humandocs/Humans/EPAR/intrinsa/intrinsa.htm 4 Procter and Gamble Pharmaceuticals . Data on File: (EBU-I-004-2006), 2006 5 Judd HL et al. Effect of oophorectomy on circulating testosterone and androstenedione levels in patients with endometrial cancer. Am J Obstet Gynecol 1974; 118(6):793-798. 6 Vermeulen A. The hormonal activity of the postmenopausal ovary. J Clin Endocrinol Metab. 1976; 2:247-253 7 Laughlin GA et al . Hysterectomy, oophorectomy, and endogenous sex hormone levels in older women: the Rancho Bernardo study. J Clin Endocrinol Metab. 2000; 85:645-651. 8 Longcope C. C Adrenal and Gonadal Androgen Secretion in Normal Females. Clinics in Endocrinology and Metabolism; Vol 15 (2): 213-228. 9 Shifren JL et al. Position Statement The role of testosterone therapy in postmenopausal women: position statement of the North American Menopause Society. Menopause 2005; 12(5): 497-511 10 Dennerstein L et al . Hypoactive Sexual Desire Disorder in Menopausal Women: a Survey of Western European Women. J Sex Med. 2006; 3: 212-222 11 WHO. International Statistical Classification of Diseases and Related Health Problems. 10th Revision Version for 2006. Available at www.who.int/classifications/apps/icd/icd10online/ Last accessed 1 February 2007 12 Basson R et al. Report of the international consensus development conference on female sexual dysfunction: definitions and classifications. J Urol. 2000; 163:888-893. 13 American Psychiatric Association. Sexual and gender identity disorders. Diagnostic and statistical manual of mental disorders, 4 th edn, text revision (DSM -IV-TR). Washington , DC : American Psychiatric Association; 2000: 535-582. 14 European Public Assessment Report Summary for Public (EPAR) Intrinsa, Summary for the public www.emea.europa.eu/humandocs/Humans/EPAR/intrinsa/intrinsa.htm   home > Procter & Gamble > news     Legal Policy | Copyright © 2005-2006 The Information Company Private Limited. All rights reserved.