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Prescriber's Guide

DHEA

Vaginal Cream

DHEA Vaginal Cream
WHAT IS DHEA VAGINAL CREAM?

DHEA (dehydroepiandosterone) is a hormone that’s naturally produced by the adrenal glands and has been clinically studied for the treatment of dyspareunia (painful intercourse), a symptom of vaginal dryness and atrophy which may occur during menopause.1,2

HOW IS DHEA VAGINAL CREAM COMPOUNDED?

DHEA vaginal cream is commonly compounded in a hypoallergenic cream base in the following strengths for vaginal application:

DHEA Vaginal Cream 2.5mg/ml, 5mg/ml, 10mg/ml

HOW DOES DHEA WORK IN THE HUMAN BODY?

DHEA (Dehydroepiandosterone) is a naturally occurring steroid produced by the adrenal glands. It is a precursor of steroid hormones like testosterone and estradiol. DHEA has weak androgenic activity, weak estrogenic activity and neurosteroid activity, and acts as a prohormone of androgens and estrogens depending on its dosage and route of administration. Levels of these steroids decrease throughout life and are 70-80% lower in the elderly relative to levels in young adults.

As a medication, DHEA may be used to restore or increase DHEA levels in deficiency or old age, for menopausal women as a weak androgen or to treat vaginal atrophy and sexual dysfunction, and in its sulfate form, for cervical dilation during childbirth.

WHICH CONDITIONS HAS DHEA BEEN STUDIED FOR?

DHEA has been studied for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.1,2

WHAT ARE THE RESULTS OF THE CLINICAL STUDIES?

Clinical studies indicate that DHEA has been shown to increase sexual desire, sexual arousal, sexual lubrication, orgasm, and vaginal dryness when treating women suffering from severe dyspareunia.1,2

In 2009, Labrie et al conducted a randomized, double-blind, and placebo-controlled phase III clinical trial which was published in the journal Menopause. The study included 216 participants. Inclusion criteria included post-menopausal women between the ages of 40 and 75 years of age who were experiencing either vaginal dryness, vaginal or vulvar irritation, or dyspareunia.

After 12 weeks of the study, the group administered a 1% DHEA vaginal dose nightly at bedtime showed a 49% improvement in sexual desire according to the MENQOL questionnaire and a 23% improvement in sexual desire according to the ASF questionnaire. The 1% DHEA group showed an improvement in sexual arousal by 68%, sexual lubrication by 39 %, ability to achieve orgasm by 75%, and vaginal dryness by 57 % according to the ASF questionnaire when compared to the placebo.

Another Phase III, open-label study published in the Journal of Hormone Molecular Biology and Clinical Investigations, Bouchard took a closer look at the use of intravaginal DHEA as a treatment for sexual function. The study took place over the course of a year, and 154 post-menopausal women with vaginal atrophy were administered intravaginal 0.5% DHEA on a daily basis.

When the study concluded, the women showed marked improvements in multiple parameters of sexual function examined by the questionnaire, including increased desire by 28%, arousal by 49%, lubrication by 115%, ability to orgasm by 51%, satisfaction by 41% and improvements in pain by 108%.

In both studies, the application of intravaginal DHEA demonstrated benefits for the sexual function of post-menopausal women. At the doses of DHEA 0.5% and 1%, the levels of DHEA metabolites, estradiol and testosterone, in the serum remained well within safe limits.

AT WHICH DOSES HAS DHEA BEEN STUDIED AND HOW SHOULD IT BE USED?

Clinical studies using intravaginally administered DHEA used strengths varying between 0.5-1% daily at bedtime.1,2

WHAT SIDE EFFECTS MAY BE CAUSED BY DHEA VAGINAL PREPARATIONS?
  • Vaginal discharge
  • Abnormal Pap smear
WHAT PRECAUTIONS SHOULD BE KEPT IN MIND WHEN PRESCRIBING DHEA VAGINAL CREAM?

Current or Past History of Breast Cancer. Estrogen is a metabolite of DHEA. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. DHEA Suppositories have not been studied in women with a history of breast cancer.

IS DHEA SAFE DURING PREGNANCY AND CAN I USE IT WHEN BREASTFEEDING?
Pregnancy and Lactation

There is no data with DHEA vaginal cream use in pregnant women regarding any drug-associated risks. Animal reproduction studies have not been conducted with DHEA.

Lactation

There is no information on the presence of DHEA in human milk, the effects on the breastfed infant, or the effects on milk production

WHEN SHOULD DHEA VAGINAL CREAM NOT BE PRESCRIBED?
  • Undiagnosed abnormal genital bleeding
  • Pregnancy
  • Lactation
  • Current or Past History of Breast Cancer
HOW DOES DHEA AFFECT HORMONE LEVELS IN THE HUMAN BODY?

In a study conducted in postmenopausal women, administration of the DHEA vaginal
suppository once daily for 7 days resulted in a mean DHEA Cmax of 4.4 ng/mL and mean DHEA AUC of 56.2 ng/mL, which were significantly higher than those in the group treated with placebo. The Cmax and AUC0-24 of the metabolites testosterone and estradiol were also slightly higher in women treated with the DHEA vaginal suppository compared to those receiving placebo.

In two primary efficacy trials, daily administration of DHEA vaginal suppositories for 12 weeks

increased mean serum Ctrough of DHEA and its metabolites testosterone and estradiol by 47%, 21% and 19% from baseline, respectively. This comparison based on Ctrough may underestimate the magnitude of increase in DHEA and metabolites’ exposure because it does not take into account the overall concentration-time profile following administration of DHEA Vaginal Suppositories.

HOW SHOULD DHEA VAGINAL CREAM BE STORED?
  • Keep tightly closed after each use
  • Keep out of reach from children.
  • Store in a cool and dry place.
REFERENCES
  1. Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berger L, Gilbert L, Martel C, Balser J. Effect of intravaginal dehydroepiandrosterone (Prasterone) on libido and sexual dysfunction in postmenopausal women. Menopause. 2009 Sep-Oct;16(5):923-31.
  2. Bouchard C, Labrie F, Derogatis L, Girard G, Ayotte N, Gallagher J, Cusan L, Archer DF, Portman D, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Group.. Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC-230 open-label study. Horm Mol Biol Clin Investig. 2016 Mar;25(3):181-90.
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Costa Mesa, CA 92627

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