U.S. FDA approved a new product Intrarosa that contains active ingredient prasterone for the treatment of pain in postmenopausal women during sexual intercourse. This pain intensity might be moderate to severe and condition is known as dyspareunia. Intrarosa is first kind of this category approved by FDA. Prosterone is basically a steroidal hormone that produces naturally inside body ( endogenous Production). It is also know as Dehydroepiandrosterone (DHEA) and circulates in human body in large amounts. Prosterone plays many physiological role in the body like biosynthesis of sex hormones like estrogens and androgens.
Postmenopuasal problems are very common in women like flushing, mood swings, metabolic changes in the body and osteoporosis. According to research major underlying cause of intense pain during sexual intercourse in postmenopausal women is atrophy of internal membrane of vulva and vagina. It is proposed that this atrophy is triggered due to low levels of estrogen circulating in the body and vaginal tissues for a long time and condition is known as vulvar and vaginal atrophy (VVA).
Basic mechanism of Intrarosa (prasterone) is that it decreases the adrenal insufficiency in women but still exact pathway by which it works is not fully understood due to inadequate clinical data. According to FDA its efficacy was established after 12 week clinical trials and women who were taking intrarosa during these trials experienced remarkable decrease in the severity of pain.
Intrarosa/prasterone Side effectsAccording to data obtained from clinical trials all side effects were minor to moderate. During these clinical trials no life threatening or lethal side effect was reported. Detail of these side effects is as follows
Minor Side effects
- Irritation during insertion
- Sense of discomfort in lower abdominal
Moderate Side effects
- Vaginal Discharge
- Abnormal Pap smear
- Vaginal pain
- Vaginal odor
Intrarosa/prasterone Uses or Prescribing Information
Though, prasterone is available in many dietary supplements but FDA approved only vaginal pessaries of prasterone to decrease the intensity of pain during intercourse in postmenopausal women. According to clinical trials intrarosa shows its therapeutic effect when used for specified period of time. Short term usage for few days does not produce significant effect.
Intrarosa is manufacturing in the form of vaginal insert tab or pessary. Each tab or pessary contains 6.5mg of prasterone for the treatment of moderate to severe dyspareunia caused by postmenopausal vulvar/vaginal atrophy. Standard dosage frequency of intrarosa in women is 1 vaginal insert daily at bedtime with the help of applicator.