DHEA Vaginal Cream with Vitamin E and Hyaluronic Acid

Overview

Dehydroepiandrosterone (DHEA) and its metabolite dehydroepiandrosterone sulfate (DHEAS) are the most abundant circulating human adrenal steroids. Considered as the “mother hormone,” DHEA is a steroid precursor to androstenedione, testosterone, and estradiol. It is made in the adrenal glands, skin, and brain. DHEA is thought to be important in several endocrine processes, but current medical use of DHEA is mostly limited to controlled clinical trials. Over 500 scientific articles investigating DHEA have been published since the early 1990’s. Many of the clinical trials of DHEA to date have been short-term studies and have lacked a powerful study design and statistical significance needed to support therapeutic claims. The following actions are a small sampling of the various effects that DHEA appears to have on the body:

  • DHEA may be made by the central nervous system. Concentrations of DHEA are higher in the brain than in other organs and it appears to have excitatory activity at both GABA and NMDA receptors.1
  • Animal studies have shown that DHEA expedites the re-epithelialization of donor skin-graft sites after a burn injury.2
  • DHEA can be converted to androstenedione, testosterone, and estradiol by peripheral tissues.1
  • DHEA has demonstrated an inhibition of platelet aggregation after 14 days of administration. The degree of inhibition appears to be time and dose dependent.3
  • DHEA’s effect on the immune system is not clear, however DHEA has been shown to increase the numbers of natural killer cells in aging women.1
  • Lower levels of DHEA have been noted in patients with systemic lupus erythematosus (SLE) at the time of diagnosis. Chronic corticosteroid treatment may cause adrenal atrophy, contributing to lowered DHEA levels in these patients. Supplementation of DHEA in SLE may augment immune system activity and potentially offset the undesired effects of chronic corticosteroid use in these patients.4

Indications

Symptoms of painful intercourse and vaginal atrophy may be a result of menopause. Vaginal DHEA formulations have been studied to alleviate these symptoms.

How Supplied

Commercially-Available DHEA Options

DHEA is widely available as an over-the-counter nutritional supplement. In November 2016, DHEA was also approved by the FDA under the brand name IntrarosaTM to treat women experiencing moderate to severe pain during sexual intercourse, a symptom of vulvar and vaginal atrophy (VVA), due to menopause.5

Compounded DHEA Options

As determined by a prescriber, DHEA may be compounded for patients that would benefit clinically from a higher dosage of DHEA delivered vaginally and with hyaluronic acid and vitamin E added as excipients. The most popular formulation compounded at Galleria Medical Pharmacy is DHEA 10 mg/gm Vaginal Cream. It is dispensed in a 30 gram tube and comes with a vaginal applicator, though other strengths and versions are also available upon request. The formulation also contains hyaluronic acid 2.5 mg/gm and vitamin E 200 IU/gm to aid in lubrication of the local area. Found naturally throughout the body, each molecule of hyaluronic acid attracts and retains up to 1,000 times its weight in moisture, which may aid in reducing painful sex and improving vaginal dryness, itching, burning, and thinning.6

Storage

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Reference

  1. Kroboth PD, Slalek FS, Pittenger AL et al. DHEA and DHEA-S: a review. J Clin Pharmacol 1999;39:327-348.
  2. Araneo BA, Ryu SY, Barton S, et al. Dehydroepiandrosterone reduces progressive dermal ischemia caused by thermal injury. J Surg Res 1995;59:250-262.
  3. Jesse Rl, Loesser K, Eich DM, et al. Dehydroepiandrosterone inhibits human platelet aggregation in vitro and in vivo. Ann N Y Acad Sci 1995;774:281-290.
  4. Sawalha AH, Kovats S. Dehydroepiandrosterone in systemic lupus erythematosus. Curr Rheumatol Rep. 2008 Aug; 10(4): 286–291.
  5. Intrarosa (prasterone) vaginal insert package insert. Quebec City, Canada: Endoceutics, Inc.; 2018 Feb.
  6. Chen J, et al. “Evaluation of the efficacy and safety of hyaluronic acid vaginal gel to ease vaginal dryness: a multicenter, randomized, controlled, open-label, parallel-group, clinical trial.” J Sex Med. 2013;10:1575-1584.

Compounding Pharmacy Statement

DHEA vaginal cream is compounded with drug components whose suppliers are registered with the FDA. While Galleria Medical Pharmacy adheres to USP <795> guidelines and applicable state and federal regulations to meet the required quality standards, the statements made regarding compounded DHEA vaginal cream have not been evaluated by the FDA for safety or clinical effectiveness. As such, this preparation is not intended to diagnose, treat, cure, or prevent any disease. For inquiries concerning this preparation, please contact (504) 267-9876.