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
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
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.
DHEA has been studied for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.1,2
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.
Clinical studies using intravaginally administered DHEA used strengths varying between 0.5-1% daily at bedtime.1,2
- Vaginal discharge
- Abnormal Pap smear
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.
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.
There is no information on the presence of DHEA in human milk, the effects on the breastfed infant, or the effects on milk production
- Undiagnosed abnormal genital bleeding
- Current or Past History of Breast Cancer
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.
- Keep tightly closed after each use
- Keep out of reach from children.
- Store in a cool and dry place.
- 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.
- 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.
The prescriber’s guide does not provide medical or legal advice. All content found on this drug info sheet, including text, images, audio, or other formats were created for informational purposes only. Viewing this prescriber’s guide, receipt of information contained in this guide, or the transmission of this information from our pharmacy does not constitute a pharmacist-patient relationship.
The medical information on this prescriber’s guide is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay seeking it because of something you have read on this drug monograph.
If you think you may have a medical emergency, call your doctor, go to the emergency department, or call 911 immediately. Harbor Compounding Pharmacy does not recommend or endorse any specific tests, physicians, products, procedures, opinions, or other information that may be mentioned on any of our content.
Medical information changes constantly. Therefore, the information on our prescriber’s guide(s) should not be considered current, complete, or exhaustive, nor should you rely on such information to recommend a course of treatment for you or any other individual. Reliance on any information provided by Harbor Compounding Pharmacy, its employees, contracted writers, or medical professionals presenting content for publication to Harbor Compounding Pharmacy is solely at your own risk.