FDA Approved First Drug Containing DHEA

Discussion in 'Scientific Studies' started by haidut, Nov 17, 2016.

  1. haidut

    haidut Member

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    I knew it was coming, the evidence in favor of DHEA is just too strong to ignore and the pharma companies are desperate for something that works. The bad news is that the more drugs based on DHEA that appear the more reason and clout FDA acquires to eventually start controlling sales of DHEA even tough it is specifically exempt from FDA's control. The other bad news, albeit mostly academic, is that the proposed mechanism of action for the newly approved drug is by raising tissue estrogen even though human studies specifically showed that it is androgens like DHT/T and DHEA's conversion into those androgens that are therapeutic for the vulvar and vaginal atrophy (VVA) of menopause. But, at least this will popularize the use of DHEA among the population, which is used judiciously, should have benefits for a host of other conditions.
    I think @Blossom asked recently in another thread about treating VVA with DHEA. Well, it looks like it was very timely :):

    FDA approves Intrarosa for postmenopausal women experiencing pain during sex

    "...The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa 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."
     
  2. Blossom

    Blossom Moderator

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  3. Wagner83

    Wagner83 Member

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    That does not sound too good to keep having access to a few quality supplements!
    I'm curious to see what dose they'll use to raise estrogen and whether treatment works or not.
     
  4. OP
    haidut

    haidut Member

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    The treatment already worked, that is why FDA approved it as a drug. I have also recently seen trials with DHEA for female infertility, female senile dementia, and andropause (in combination with pregnenolone) so don't be surprised to see other off-label usage approvals as well. Like I said, Big Pharma is not doing well these days and they'll throw money at anything that seems to work better than their drugs. And don't think they don't monitor forums like this one for ideas or just to sample public opinion of the so-called "early adopters".
     
  5. Blossom

    Blossom Moderator

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    The name is remarkably similar to pansterone. I wonder if they are copying you.:confused2
     
  6. Wagner83

    Wagner83 Member

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    Mm ok, but was it approved because it did raise estrogens levels and thus agreed with their main idea? You seem to say T and dht are responsible for the efficiency of the treatment.
     
  7. OP
    haidut

    haidut Member

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    The actual clinical trials never found elevated estrogens due to DHEA treatment. Here is the first preliminary study from the same group that did the clinical trial. As you can see neither E2 nor E1S were raised due to estrogen treatment.
    Serum levels of sex steroids and metabolites following 12 weeks of intravaginal 0.50% DHEA administration. - PubMed - NCBI
    "...In agreement with the mechanisms of intracrinology, all serum sex steroids and metabolites concentrations after 12 weeks of daily intravaginal administration of 0.50% DHEA remain well within the limits of normal postmenopausal women. More specifically, the 12-week serum E2 concentration was measured at 22% below the average normal postmenopausal value (3.26 versus 4.17 pg/ml), thus eliminating any fear of E2 exposure outside the vagina. In addition, serum E1-S, a particularly reliable indicator of global estrogenic activity, shows serum levels practically superimposable to the value observed in normal postmenopausal women (219 versus 220 pg/ml). Similarly, serum ADT-G, the major metabolite of androgens, remains within normal postmenopausal values. The present data confirm the intracellular transformation of DHEA in the vagina resulting in local efficacy without any systemic exposure to sex steroids, observations which are in agreement with the physiological mechanisms of menopause."

    There are older studies showing testosterone (in humans) and both T and DHT in rodents reversed vaginal atrophy. DHEA also worked while estrogen did not. So, the clinical trial never found elevations of estrogen or establish that higher estrogen is the reason for the benefit. FDA approved it strictly due to observed benefit. This is very similar to the SSRI drugs where FDA approved since they seemed to work but the officially given reason that the benefit is due to elevated serotonin is bunk.

    The dose of DHEA they used was very Peatarian - 6.5mg daily, delivered intravaginally. Like I said, these people either read this blog or the same studies as us and Peat. In that dose DHEA, especially in women, converts almost entirely into androgens. DHEA is much more androgenic in females than it is in males, so basically this trial used the equivalent of 2mg - 3mg testosterone daily, because that is how DHEA normally metabolized in females.
    Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy. - PubMed - NCBI
    "...METHODS: Placebo was administered daily to 157 women while 325 women received 0.50% (6.5 mg) DHEA daily for 12 weeks. All women were postmenopausal meeting the criteria of vulvovaginal atrophy (VVA), namely moderate to severe dyspareunia as their most bothersome symptom of VVA in addition to having ≤5% of vaginal superficial cells and vaginal pH > 5.0. The FSFI questionnaire was filled at baseline (screening and day 1), 6 weeks and 12 weeks. Comparison between DHEA and placebo of the changes from baseline to 12 weeks was made using the analysis of covariance test, with treatment group as the main factor and baseline value as the covariate."
     
  8. High_Prob

    High_Prob Member

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    Haidut - You are the freaking man...
     
  9. Hollybea

    Hollybea Member

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  10. Wagner83

    Wagner83 Member

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    Interesting haidut.
     
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