Intrarosa Postmenopausal

November 18, 2016 –  Do we really need another steroid hormone to treat women? If yes, does it have to be DHEA? The American Food & Drug Administration (FDA) thinks so.  FDA just approved  Prasterone (Intrarosa) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. imageIntrarosa is the first FDA approved product containing the active ingredient Prasterone, which is also known as dehydroepiandrosterone (DHEA).

During menopause, levels of estrogen decline in vaginal tissues, which may cause a condition known as VVA, leading to symptoms such as pain during sexual intercourse.

“Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women,” said Audrey Gassman, M.D., deputy director of the Division of Bone, Reproductive, and Urologic Products (DBRUP) in the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research (CDER). “Prasterone (Intrarosa) provides an additional treatment option for women seeking relief of dyspareunia caused by VVA.”

Efficacy of Prasterone (Intrarosa), a once-daily vaginal insert, was established in two 12-week placebo-controlled clinical trials of 406 healthy postmenopausal women, 40 to 80 years of age, who identified moderate to severe pain during sexual intercourse as their most bothersome symptom of VVA. Women were randomly assigned to receive Prasterone (Intrarosa) or a placebo vaginal insert. Prasterone (Intrarosa), when compared to placebo, was shown to reduce the severity of pain experienced during sexual intercourse.

The safety of Prasterone (Intrarosa) was established in four 12-week placebo-controlled trials and one 52-week open-label trial. The most common adverse reactions were vaginal discharge and abnormal Pap smear.

Although DHEA is included in some dietary supplements, the efficacy and safety of those products have not been established for diagnosing, curing, mitigating, treating or preventing any disease. Overall, DHEA may not be as begnin as it may appear here. If we consult MedlinePlus for safety information on supplements (i.e, DHEA in this case), it becomes clear that there exists quite an array of adverse effects to go with the use of DHEA. Patients using Prasterone (Intrarosa) might be well advised to be careful. The brand name Intrarose might be misleading.

Share
Tags: , , , , ,
About the Author
thassodotcom

Ph.D.; Professor in Pharmacology and Toxicology.
Senior expert in theragenomic and personalized medicine and individualized drug safety.
Senior expert in pharmaco- and toxicogenetics.
Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.


4 comments on “Intrarosa Postmenopausal
  1. 86Cecila says:

    I see you don’t monetize your site, don’t waste your traffic, you can earn extra cash every month because you’ve got high quality content.
    If you want to know how to make extra $$$, search for:
    best adsense alternative Wrastain’s tools

  2. Considering trying Sildenafil for relief of my vaginal elasticity. As a female, I have a troubling question. Have any of you heard of taking Viagra for postmenopausal symptoms? I purchase it on the web using Bitcoin (which I prefer to use, versus having my credit card number stolen) from https://canadianpharmacy.to/ for my husband’s e.d., but I found out that the active ingredient in Viagra can help with postmenopausal symptoms. I’ve been experiencing dryness and much less sensitivity and elasticity, and it makes having sex with my hubby difficult and not very enjoyable. We’ve tried just using lubrication, but the feeling is still not as wonderful as before. Does anyone have any experience with this? Thanks to anyone who can offer even a small bit of insight – it’s something I don’t even want to talk to my doc about. I guess it’s like feeling less of a woman somehow.

  3. Recently learned about taking Viagra to treat my postmenopausal symptoms. As a female, I have an embarrassing question. Has anyone heard of anyone taking sildenafil citrate for postmenopausal symptoms? I order it on the web using Bitcoin (which I prefer to use, versus having my credit card number stolen) from https://canadianpharmacy.to/ for my spouse’s jet lag, but I found out that the active ingredient in Viagra can help with my symptoms. I’ve been experiencing dryness and much less sensitivity and elasticity, and it makes making love to my husband difficult and not very enjoyable. We’ve tried using things like lubrication, but the sensation is still not as good as before. Does anyone have any experience with this? Thank you to anyone who can offer even a little bit of insight – it’s something I don’t even want to talk to my doc about. I sort of feel like less of a woman somehow.

  4. marip73 marip73 says:

    Intrarosa shall be available in Europe too.

    On 9 November 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Intrarosa, intended for the treatment of vulvar and vaginal atrophy in postmenopausal women.

    http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004138/smops/Positive/human_smop_001218.jsp&mid=WC0b01ac058001d127

Leave a Reply

Optional: Social Subscribe/Login



Your email address will not be published. Required fields are marked *

*

thasso: conditions

thasso post: magazine

View my Flipboard Magazine.

thasso: follow us

thasso: chat

You must be a registered user to participate in this chat.

thasso: tweets

thasso: categories

thasso: archives

Top