Intrinsa
Encyclopedia
Intrinsa is a testosterone
patch by Procter & Gamble
designed to treat Female Sexual Dysfunction (FSD).
in women. Doctors have used a range of other treatments for women, including various hormones, antidepressants, and male impotence drugs like Viagra, Levitra, and Cialis. According to a P&G survey on female health 30 million women are naturally menopausal, 3 million are distressed by their lack of sexual desire, and 20% of 25 million women who are surgically menopausal are distressed.
through the skin into the bloodstream. In women, testosterone is naturally produced by the ovaries and the adrenal gland. However, levels of the hormone decline with age, sometimes dramatically so after the menopause
or after a hysterectomy
. Testosterone therapy is systemic and needs to be applied over a period of weeks or months to have a noticeable effect. P&G licensed the treatment to Watson Pharmaceuticals.
The amount of testosterone in the patch, 300 µg/24hrs, is significantly lower than in testosterone patches for men. The patch is virtually transparent and about the size of an egg and is worn just below the navel and changed twice weekly.
The patch was granted a license from the European Medicines Agency
in July, and is available on Britain
's National Health Service
from March 2007. It will initially only be available on prescription for post-menopausal women with diagnosed sexual problems.
However, in December 2004 the United States
the 14-member Food and Drug Administration (FDA) advisory committee, plus voting consultants, for Reproductive Health Drugs unanimously rejected Procter and Gamble's fast-track request for Intrinsa citing concerns about off-label use. In Canada, post-menopausal women have been able to obtain government-approved testosterone treatment since 2002. In Australia, post-menopausal women can use Organon
testosterone implants which have to be surgically inserted and last from three to six months.
Testosterone
Testosterone is a steroid hormone from the androgen group and is found in mammals, reptiles, birds, and other vertebrates. In mammals, testosterone is primarily secreted in the testes of males and the ovaries of females, although small amounts are also secreted by the adrenal glands...
patch by Procter & Gamble
Procter & Gamble
Procter & Gamble is a Fortune 500 American multinational corporation headquartered in downtown Cincinnati, Ohio and manufactures a wide range of consumer goods....
designed to treat Female Sexual Dysfunction (FSD).
Background
FSD covers at least four different conditions: problems with desire, arousal, achieving orgasm, and genital pain. The patch aims to increase libidoLibido
Libido refers to a person's sex drive or desire for sexual activity. The desire for sex is an aspect of a person's sexuality, but varies enormously from one person to another, and it also varies depending on circumstances at a particular time. A person who has extremely frequent or a suddenly...
in women. Doctors have used a range of other treatments for women, including various hormones, antidepressants, and male impotence drugs like Viagra, Levitra, and Cialis. According to a P&G survey on female health 30 million women are naturally menopausal, 3 million are distressed by their lack of sexual desire, and 20% of 25 million women who are surgically menopausal are distressed.
Method
Intrinsa works by releasing the hormone testosteroneTestosterone
Testosterone is a steroid hormone from the androgen group and is found in mammals, reptiles, birds, and other vertebrates. In mammals, testosterone is primarily secreted in the testes of males and the ovaries of females, although small amounts are also secreted by the adrenal glands...
through the skin into the bloodstream. In women, testosterone is naturally produced by the ovaries and the adrenal gland. However, levels of the hormone decline with age, sometimes dramatically so after the menopause
Menopause
Menopause is a term used to describe the permanent cessation of the primary functions of the human ovaries: the ripening and release of ova and the release of hormones that cause both the creation of the uterine lining and the subsequent shedding of the uterine lining...
or after a hysterectomy
Hysterectomy
A hysterectomy is the surgical removal of the uterus, usually performed by a gynecologist. Hysterectomy may be total or partial...
. Testosterone therapy is systemic and needs to be applied over a period of weeks or months to have a noticeable effect. P&G licensed the treatment to Watson Pharmaceuticals.
The amount of testosterone in the patch, 300 µg/24hrs, is significantly lower than in testosterone patches for men. The patch is virtually transparent and about the size of an egg and is worn just below the navel and changed twice weekly.
Testing and release to market
In P&G's studies over six months of surgically menopausal women, those who received a placebo said satisfying sexual activity increased by an average of 19%, vs. a 73% increase for Intrinsa patch users. In the placebo group, women had an average increase in satisfying sexual episodes of 0.5 per month, while those with patches had an average increase of 1.9 episodes per month.The patch was granted a license from the European Medicines Agency
European Medicines Agency
The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
in July, and is available on Britain
United Kingdom
The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...
's National Health Service
National Health Service
The National Health Service is the shared name of three of the four publicly funded healthcare systems in the United Kingdom. They provide a comprehensive range of health services, the vast majority of which are free at the point of use to residents of the United Kingdom...
from March 2007. It will initially only be available on prescription for post-menopausal women with diagnosed sexual problems.
However, in December 2004 the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
the 14-member Food and Drug Administration (FDA) advisory committee, plus voting consultants, for Reproductive Health Drugs unanimously rejected Procter and Gamble's fast-track request for Intrinsa citing concerns about off-label use. In Canada, post-menopausal women have been able to obtain government-approved testosterone treatment since 2002. In Australia, post-menopausal women can use Organon
Organon International
Organon is a human pharmaceutical company headquartered in Oss, Netherlands. In November 2007 the company became a part of Schering-Plough Corporation, acquired Organon, active pharmaceutical ingredient producer Diosynth , and its veterinary pharmaceutical sister company Intervet from Akzo Nobel. ...
testosterone implants which have to be surgically inserted and last from three to six months.