Dehydroepiandrosterone (DHEA) is a hormone that your body naturally produces in the adrenal gland. DHEA helps produce other hormones, including testosterone and estrogen. DHEA concentration decreases with age, therefore, DHEA has been considered a hormone that reduces the symptoms associated with aging.

Estrogens are female hormones naturally produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle during the childbearing years. The ovaries begin to produce less estrogen after menopause (the change of life). Estrogen replacement medicine is often prescribed to make up for the lower amount of estrogen.

Vitamin E, a fat-soluble vitamin, has been shown to increase lubrication and soothe the vaginal lining.

One size doesn’t fit all and every patient is unique. Drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of a patient by a pharmacist as the result of a practitioner’s prescription drug order. While compounded medications are not FDA-approved, they serve an important patient need—especially when FDA-approved medication is not available for treatment. Our formulations are made to order in small batches to ensure freshness. The specific ingredients in your compounded formula will depend on your specific concerns and goals. It should be understood that your personal healthcare practitioner will make the final decision.

Yes! All of our compounded formulations, regardless of ingredients, are eligible for Flexible Spending Accounts (FSA) and Health Saving Accounts (HSA).

Vaginal tissues are sensitive to estrogen, and the loss of estrogen that occurs during menopausal transition can render these tissues fragile and cause thinning, drying and inflammation. Researchers say nearly 50% of women develop symptoms related to vaginal atrophy within a few years of menopause. Although menopause is the most common cause, vaginal atrophy may result from anything that lowers estrogen production including; chemotherapy, radiation, certain medications and surgical hysterectomy. Unlike vasomotor symptoms, vaginal atrophy does not improve over time without treatment.

Signs and symptoms may include:

• Vaginal dryness

• Vaginal burning

• Vaginal discharge

• Genital itching

• Burning with urination

• Urgency with urination

• Frequent urination

• Recurrent urinary tract infections

• Urinary incontinence

• Light bleeding after intercourse

• Discomfort with intercourse

• Decreased vaginal lubrication during sexual activity

• Shortening and tightening of the vaginal canal

Vaginal dryness

Multiple studies confirm that about 27% to 60% of women report moderate to severe symptoms of vaginal dryness in association with menopause. Furthermore, the urinary tract contains estrogen receptors in the urethra and bladder, and as the loss of estrogen becomes evident, patients may experience urinary tract infections.

Dyspareunia

Dyspareunia, painful intercourse, is one of the most common symptoms of postmenopause. According to the American College of Obstetricians and Gynecologists around 75% of women experience painful intercourse at some time.

Yes, the Vaginal Atrophy Formula is a once daily vaginal cream that may contain a customized blend of estriol and dehydroepiandrosterone (DHEA). The hormones used in the Vaginal Atrophy Formula are structurally identical to the hormones your body produces naturally. HRT is a regimen aimed at relieving the symptoms that some women experience during menopause. HRT works by replacing the hormones that your body stops producing when you go through menopause or when you have had surgery to remove your ovaries.

What is estriol?

Estriol is the main estrogen in pregnancy. Emerging evidence indicates that estriol has potential benefits that include improved control of menopausal symptoms and better urogenital health.

What is dehydroepiandrosterone (DHEA)?

DHEA is the most abundant circulating steroid hormone in humans. Low levels of DHEA have been associated with age-related changes. The daily intravaginal administration of DHEA has shown to significantly improve symptoms of moderate to severe vaginal dryness, painful intercourse and libido in postmenopausal women.

Based on research and patient testimonials, it usually takes 2 to 3 weeks before you will feel the initial benefits; however, each patient is unique and time frames may differ. It may also take your body time to get used to it.

• The Vaginal Atrophy Formula is for vaginal use only. If this medicine gets in your eyes or mouth, rinse with water.

• Follow all directions on your prescription label and read all medication guides or instruction sheets.

• The Vaginal Atrophy Formula may be applied at any time of day, but should be applied at or around the same time each day.

• Empty your bladder and wash your hands with soap and water before and after applying the medicine. Do not allow other people to get this medicine on their skin. If this happens, wash the area thoroughly with soap and water.

• Insert your dose roughly 2 inches into the vaginal canal and apply to your vulvar area (clitoris, along the labia) once daily for 3 weeks, then twice weekly thereafter (for example, Monday and Thursday).

• Avoid exposing your sexual partner to your vaginal cream by not having sexual intercourse right after using the Vaginal Atrophy Formula. Your partner might absorb the medicine through his penis if it comes in contact with the medicine.

• The Vaginal Atrophy Formula is not edible.

• You should not shower or swim for at least 2 hours after applying the Vaginal Atrophy Formula.

• Your doctor should check your progress on a regular basis to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms while using estrogen therapy.

• If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short term. Any doctor or surgeon who treats you should know that you are using estrogens.

Do not start using the Vaginal Atrophy Formula if you:

• Have unusual vaginal bleeding

  • Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. Report any unusual vaginal bleeding right away.

• Currently have or have had certain cancers

  • Estrogens may increase the chance of getting certain types of cancer, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use the Vaginal Atrophy Formula.

• Had a stroke or heart attack

  • Estrogens should not be used to prevent heart disease, stroke, or dementia.

• Currently have or have had blood clots

• Have been diagnosed with a bleeding disorder

• Have a history of hypersensitivity to any of the ingredients prescribed

• Think you may be pregnant

  • The Vaginal Atrophy Formula is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not use the Vaginal Atrophy Formula if the test is positive and talk to your healthcare provider.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two does at one time.

Store at room temperature away from moisture and heat between 68°F to 77°F (20°C to 25°C).

Research has shown, topically applied medications are less likely to cause the same systemic side effects or drug-to-drug interactions as oral medications; however, there is never an absolute zero chance that side effects or drug interactions will not occur. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

What should I avoid while using the Vaginal Atrophy Formula?

• Avoid getting this medicine in your eyes. If this does happen, rinse with water.

• Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using estradiol.

• Avoid using other vaginal products that may contain estriol or dehydroepiandrosterone (DHEA).

• Grapefruit may interact with estrogen and lead to unwanted side effects. Avoid the use of grapefruit products.

• Avoid using other products that may contain estriol or dehydroepiandrosterone (DHEA) unless discussed with your doctor.

What are the common side effects of the Vaginal Atrophy Formula?

Less serious, but common side effects include:

• Headache

• Breast pain

• Stomach or abdominal cramps, bloating

• Nausea and vomiting

• Hair loss

• Fluid retention

• Vaginal yeast infection

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

• New breast lumps

• Unusual vaginal bleeding

• Changes in vision or speech

• Sudden new severe headaches

• Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue

Serious, but less common side effects include:

• Heart attack

• Stroke

• Blood clots

• Dementia

• Breast cancer

• Cancer of the lining of the uterus (womb)

• Cancer of the ovary

• High blood pressure

• High blood glucose

• Gallbladder disease

• Liver problems

• Changes in your thyroid hormone levels

• Enlargement of benign tumors (“fibroids”)

These are not all of the possible side effects of the Vaginal Atrophy Formula. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects that bother you or do not go away.

What happens if I overdose?

An overdose is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

• Santoro N, Epperson CN, Mathews SB. Menopausal Symptoms and Their Management. Endocrinol Metab Clin North Am. 2015 Sep;44(3):497-515. doi: 10.1016/j.ecl.2015.05.001. PMID: 26316239; PMCID: PMC4890704.

• Rahn DD, Carberry C, Sanses TV, Mamik MM, Ward RM, Meriwether KV, Olivera CK, Abed H, Balk EM, Murphy M; Society of Gynecologic Surgeons Systematic Review Group. Vaginal estrogen for genitourinary syndrome of menopause: a systematic review. Obstet Gynecol. 2014 Dec;124(6):1147-1156. doi: 10.1097/AOG.0000000000000526. PMID: 25415166; PMCID: PMC4855283.

• Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2. PMID: 23985562.

• Crandall CJ, Hovey KM, Andrews CA, Chlebowski RT, Stefanick ML, Lane DS, Shifren J, Chen C, Kaunitz AM, Cauley JA, Manson JE. Breast cancer, endometrial cancer, and cardiovascular events in participants who used vaginal estrogen in the Women's Health Initiative Observational Study. Menopause. 2018 Jan;25(1):11-20. doi: 10.1097/GME.0000000000000956. PMID: 28816933; PMCID: PMC5734988.

• Labrie F, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Côté I, Parent J, Lavoie L, BSc AB, Martel C, Vaillancourt M, Balser J, Moyneur É; members of the VVA Prasterone Research Group. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Menopause. 2018 Nov;25(11):1339-1353. doi: 10.1097/GME.0000000000001238. PMID: 30358731.

• Bhupathiraju SN, Grodstein F, Stampfer MJ, Willett WC, Crandall CJ, Shifren JL, Manson JE. Vaginal estrogen use and chronic disease risk in the Nurses' Health Study. Menopause. 2018 Dec 17;26(6):603-610. doi: 10.1097/GME.0000000000001284. PMID: 30562320; PMCID: PMC6538478.

• Krause M, Wheeler TL 2nd, Snyder TE, Richter HE. Local Effects of Vaginally Administered Estrogen Therapy: A Review. J Pelvic Med Surg. 2009 May;15(3):105-114. doi: 10.1097/SPV.0b013e3181ab4804. PMID: 22229022; PMCID: PMC3252029.

• Hirschberg AL, Sánchez-Rovira P, Presa-Lorite J, Campos-Delgado M, Gil-Gil M, Lidbrink E, Suárez-Almarza J, Nieto-Magro C. Efficacy and safety of ultra-low dose 0.005% estriol vaginal gel for the treatment of vulvovaginal atrophy in postmenopausal women with early breast cancer treated with nonsteroidal aromatase inhibitors: a phase II, randomized, double-blind, placebo-controlled trial. Menopause. 2020 May;27(5):526-534. doi: 10.1097/GME.0000000000001497. PMID: 32049923; PMCID: PMC7188038.

• Cano A, Estévez J, Usandizaga R, Gallo JL, Guinot M, Delgado JL, Castellanos E, Moral E, Nieto C, del Prado JM, Ferrer J. The therapeutic effect of a new ultra low concentration estriol gel formulation (0.005% estriol vaginal gel) on symptoms and signs of postmenopausal vaginal atrophy: results from a pivotal phase III study. Menopause. 2012 Oct;19(10):1130-9. doi: 10.1097/gme.0b013e3182518e9a. PMID: 22914208.

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