First Medically Licensed Treatment To Help Women Rediscover Their Sexual Desire - Intrinsa Patch Significantly Improves Sexual Desire

Main Category: Menopause
Also Included In: Sexual Health / STDs;  Endocrinology
Article Date: 26 Mar 2007 - 9:00 PDT

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The first medically licensed treatment for women concerned by low sexual desire following surgically induced premature menopause* has been made available today in the UK. The female testosterone patch, called Intrinsa, is indicated for the treatment of low sexual desire associated with distress in women who have experienced an early menopause following hysterectomy involving a bilateral oophorectomy and are receiving concomitant oestrogen therapy.[ii] It is specifically developed for women in this group who are distressed by low sexual desire. Treatments have been made 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 endometriosis, fibrosis and pelvic pain.[iii] This procedure leads to a decrease in testosterone3,[iv],[v],[vi] a naturally occurring hormone in women[vii] that may be a key mediator of sexual desire.[viii]

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.[ix] Among surgically menopausal women who experience a loss of sexual desire, 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 (INTIMATE SM1 and INTIMATE SM2) involving over 1,000 surgically menopausal women with low sexual desire and associated distress on concomitant oestrogen therapy, demonstrated significantly increased sexual desire (p=0.0006 and p<0.001) and satisfying sexual activity from baseline at six months with Intrinsa compared with placebo, as well as significantly decreased personal concern due to low sexual desire.1,2 In studies SM1 and SM2, Intrinsa increased sexual desire by 56% and 49% from baseline, increased satisfying sexual activity by 74% and 51% and reduced distress by 65% and 68%.1,2 In six month studies, Intrinsa is generally well tolerated, with the most common side-effects being considered mild and reversible. Few participants discontinued treatment because of side effects. Of the 79% of patients who completed the studies, 96% elected to continue in a six-month open label study. Further long-term safety studies are ongoing.1,2

Intrinsa is a thin, clear patch worn on the abdomen, applied twice a week, which delivers a low dose of testosterone (300 micrograms/24 hours) and achieves serum testosterone concentrations compatible with premenopausal levels. The testosterone used in the patch is identical to testosterone produced naturally in all women.3

-- Further information for healthcare professionals can be found at:
www.intrinsa.co.uk

-- Patients can find further information about premature menopause at:
www.desireandmenopause.co.uk

-- Contact The Daisy Network at:
www.daisynetwork.org.uk

* 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 [x] for the persistent or recurrent deficiency and/or absence of sexual thoughts/fantasies and/or receptivity to sexual activity which causes distress or interpersonal difficulty.[xi],[xii]

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.[xiii]

In Intrinsa clinical trials, 'sexual desire', 'distress' and 'total satisfying sexual activity' were all measured using robust, validated, patient-based instruments that differentiate between HSDD women versus those with healthy sexual desire. Distress was measured using the Personal Distress Scale (PDS), which measures personal distress associated with patients' lack of sexual interest. Sexual 'activity' was measured using the Sexual Activity Log (SAL) and sexual desire was measured using the Profile of Female Sexual Function (PFSF).[xiv],16,17,18

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References

[ii] Intrinsa Summary of Product Characteristics. August 2006. http://www.emea.europa.eu/humandocs/Humans/EPAR/intrinsa/intrinsa.htm
[iii] Procter and Gamble Pharmaceuticals. Data on File: (EBU-I-004-2006), 2006
[iv] 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.
[v] Vermeulen A. The hormonal activity of the postmenopausal ovary. J Clin Endocrinol Metab. 1976; 2:247-253
[vi] 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.
[vii] Longcope C. C Adrenal and Gonadal Androgen Secretion in Normal Females. Clinics in Endocrinology and Metabolism; Vol 15 (2): 213-228.
[viii] 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
[ix] Dennerstein L et al. Hypoactive Sexual Desire Disorder in Menopausal Women: a Survey of Western European Women. J Sex Med. 2006; 3: 212-222
[x] WHO. International Statistical Classification of Diseases and Related Health Problems. 10th Revision Version for 2006. Available at http://www.who.int/classifications/apps/icd/icd10online/ Last accessed 1 February 2007
[xi] Basson R et al. Report of the international consensus development conference on female sexual dysfunction: definitions and classifications. J Urol. 2000; 163:888-893
[xii] American Psychiatric Association. Sexual and gender identity disorders. Diagnostic and statistical manual of mental disorders, 4th edn, text revision (DSM -IV-TR). Washington, DC: American Psychiatric Association; 2000: 535-582.
[xiii] European Public Assessment Report Summary for Public (EPAR) Intrinsa, Summary for the public http://www.emea.europa.eu/humandocs/Humans/EPAR/intrinsa/intrinsa.htm
[xiv] McHorney CA et al. Profile of female sexual function: a patient-based, international, psychometric instrument for the assessment of hypoactive sexual desire in oophorectomised women. Menopause 2004; 11:474-483
xvi Derogatis L et al. Validation of the profile of female sexual function (PFSF) in surgically and naturally menopausal women. J Sex Marital Ther 2004; 30:25-36.
xvii Derogatis L et al. A patient-based diary to measure sexual activity in menopausal women with HSDD. Abstract presented at: International Society for the Study of Women's Sexual Health (ISSWSH) 2004 Annual Meeting, Atlanta, Georgia, USA, October 28-31, 2004.
xviii Derogatis L et al. A patient-generated, multinational inventory to measure distress associated with low desire. Abstract presented at: International Society for the Study of Women's Sexual Health (ISSWSH) 2004 Annual Meeting, Atlanta, Georgia, USA, October 28-31, 2004.

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