Intrinsa

What is Intrinsa?

Intrinsa (testosterone patch) is a Procter & Gamble treatment for hypoactive sexual desire disorder (HSDD) or Female Sexual Dysfunbction in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women, receiving concomitant oestrogen therapy.

Pharmacology

In women who have undergone bilateral oophorectomy, serum levels of testosterone decline within days of surgery, and in some women, this fall is accompanied by a loss of sexual desire and coital frequency. Intrinsa delivers a constant low dose of testosterone, with daily levels compatible with those seen in premenopausal women.

Clincal Studies

The efficacy of Intrinsa has been studied in two double-blind, placebo-controlled phase III trials, INTIMATE SM11 and INTIMATE SM22 (Investigation of Natural Testosterone In Menopausal women Also Taking Estrogen in Surgically Menopausal women). Both trials were conducted in oophorectomised and hysterectomised women (SM1 n=562, SM2 n=533), aged 20 to 70 years with HSDD, on concomitant oestrogen (oral or transdermal).

In both trials, patients were randomised to receive either Intrinsa or placebo, twice weekly, for 24 weeks. The primary endpoint was the change from baseline in the four-week frequency of total satisfying sexual episodes during weeks 21 through to 24, measured by the Sexual Activity Log (SAL). The SAL was completed for eight weeks before, and during the 24 weeks of the study. It addressed patient physical health status, partner availability, and the frequency of sexual activity during the preceding seven days.

Secondary endpoints included other aspects of sexual function, assessed using questionnaires, such as sexual desire score and the frequency of satisfying sexual activity, and distress associated with low sexual desire. Blood samples were also collected at baseline and after 24 weeks of treatment to determine hormone levels.

At 24 weeks, results from SM1 showed a significant increase from baseline in the frequency of total satisfying sexual activity of 2.1 episodes per four weeks in the testosterone group, compared with an increase of 0.98 episodes per four weeks in the placebo group. The testosterone group also experienced significant improvements in sexual desire and a decrease in distress at 24 weeks. The decrease in personal distress was also observed at week four and at all subsequent time points throughout the study. Adverse effects, including androgenic effects, occurred with similar frequency in the placebo and testosterone-treated groups. Approximately 30 per cent of women experienced application site reactions; most were described as mild.

At 24 weeks, results from SM2 showed that total satisfying sexual activity increased significantly in the testosetrone group compared with placebo. Patients receiving testosterone had a mean increase of 1.56 satisfying episodes per four weeks (corresponding to a 51 per cent increase over the baseline mean) compared with a mean increase of 0.73 for the placebo group.

The overall incidence of adverse effects and withdrawals were similar between the placebo and treatment groups. The most common adverse effects were application site reactions, upper respiratory infection, facial hair and headache. The overall incidence of androgenic adverse effects was higher in the testosterone group (19.5 per cent) compared with placebo (11.3 per cent); most were reported to be mild.

References

1. Simon J, Braunstein G, Nachtigall L et al. Testosterone patch increases sexual activity and desire in surgically menopausal women with hypoactive sexual desire disorder. J Clin Endocrinol Metab, 2005: 90(9); 5226-33.
2. Buster JE, Kingsberg SA, Aguirre O et al. Testosterone patch for low sexual desire in surgically menopausal women: a randomized trial. Obstet Gynecol 2005:105 (5); 944-52.

Dosage and Administration

Intrinsa is a transdermal testosterone patch that is applied to the abdominal skin. This method of application is more convenient than other methods of testosterone replacement and provides a slow, steady, and consisent dosage rate so that a constant level of testosterone can be maintained.

Testosterone levels affect sexual desire and libido in both men and women but naturally decrease in women as they age. Various medical conditions can also cause a reduction in the level of this hormone and this, in turn, can lead to loss of interest in sexual activities, a reduction in libido, mood changes and memory lapses.

Intrinsa helps to alleviate these symptoms by replacing the 'missing' testosterone. Other possible benefits of Intrinsa include vaginal lubrication and libido, clitoral sensitivity and heightened arousal.

However, before using Intrinsa patches, it is essential that you read all of the Intrinsa information, including the warnings, precautions and contra-indications and understand both the benefits and the side effects of Intrinsa usage.

Application

Intrinsa is a thin, transparent, oval-shaped patch that may worn inconspicuously on the abdomen and under clothing. It is applied in four simple steps;

1. Tear open the sachet containing Intrinsa patch. Do not use scissors as the patch may be damaged accidentally. Remove the Intrinsa patch. Apply the Intrinsa patch immediately after removing it from the sachet.
2. Hold the Intrinsa patch; remove half of the protective liner that covers the sticky part of the Intrinsa patch. Try to avoid touching the adhesive side of the Intrinsa patch.<.li>
3. Apply the sticky side of the Intrinsa patch to the selected area of skin. Press the adhesive side of the patch firmly into place for about 10 seconds.
4. Fold back Intrinsa patch and carefully remove the other half of the liner. Press the entire Intrinsa patch firmly against the skin using the palm of the hand for about 10 seconds. Gently test the edges of the patch to make sure that they stick to the skin. If an area of the patch lifts, apply pressure to that area.

Intrinsa patches should be replaced every 3 to 4 days, which means using two Intrinsa patches each week. For example: If an Intrinsa patch is applied on Sunday, then it should be replaced no later than the following Wednesday.

Side Effects

The following side effects occur commonly at the application site:

• rash
• irritation
• itching
• redness

Other less common but more serious side effects of Intrinsa are;

• increase in the amount of hair on the chin or upper lip
• hair loss
• acne
• migraine
• insomnia/inability to sleep properly
• voice deepening or hoarseness
• breast pain
• weight gain

If any of the above mentioned side effects become persistent, or if you notice any side effects of Intrinsa not listed here, you should consult your doctor.

Precautions

Intrinsa treatment is intended only for women between the ages of 45 and 60 who have been bilaterally oophorectomised and hysterectomised (have surgically induced menopause). Intrinsa may cause harm to an unbord child must not be used by women who are pregnant, planning to become preganant or are breastfeeding.

Storage

Do not store above 30°C (86°F).

Do not refrigerate or freeze.

Keep out of the reach and sight of children.

Do not allow anyone who is or may be pregant to come into contact with Intrinsa