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Article: Compounded HRT for Women's Health

Compounded HRT for Women's Health

 

Women's health is a complex and multi-faceted subject that encompasses a wide range of matters. One area that support women's health is hormone replacement therapy (HRT), which can be used to alleviate symptoms associated with menopause and other hormonal imbalances.

HRT involves replacing natural hormones in the body, such as estrogen and progesterone, in order to alleviate symptoms such as hot flashes, night sweats, vulvovaginal atrophy, including vaginal dryness and dyspareunia, now collectively termed: genitourinary syndrome of menopause (GSM).¹ Other symptoms associated with perimenopause and menopause that respond to estrogen include sleep disturbances, mood swings/depression, and, in some cases, joint aches and pains.  HRT can also help to prevent osteoporosis characterized by a loss of bone density.²

Women undergoing treatment for menopausal symptoms such as hot flashes require systemic estrogen therapy in which hormones are made to enter and circulate the bloodstream to reach all parts of the body³, while women being treated for menopausal genitourinary syndrome (GSM) alone should receive low-dose vaginal estrogen instead of systemic estrogen. All types of estrogen are effective in relieving hot flashes and thankfully available in many forms, including topical, oral, transdermal gels and lotions, and vaginal rings.¹ Although the potency, and thus the dosage, of these estrogen supplements vary, their ability to relieve hot flashes remains largely similar while the compound and dose selection is based on patient preference, drug availability, and cost.¹

 

Side effects

While HRT can be highly effective in managing these symptoms, there are also potential risks associated with the therapy. For example, HRT has been linked to an increased risk of breast cancer, heart disease, and stroke.  As a result, many women are hesitant to take HRT, and are instead looking for alternative options.

One such alternative is pharmaceutical compounding, which involves the creation of custom-made medications that are tailored to the specific needs of an individual patient. Compounded HRT is typically made using bio-identical hormones, molecules that are chemically identical to the hormones naturally occurring in the body. The hormones most commonly compounded are estradiol, estrone, estriol, progesterone, testosterone, and dehydroepiandrosterone (DHEA) and these can reduce the risk of side effects, as the body is able to recognize and process the hormones more easily.

Pharmaceutical compounding also allows for a greater degree of flexibility in terms of dosing, as the hormones can be tailored to the individual needs of each patient. Compounding pharmacies can also offer a wide range of other forms of the medication that is catered per the customers needs, such as creams and suppositories for vaginal dryness and pain, as well as oral tablets, capsules, and pills

 

While hormone replacement therapy can be highly effective in managing symptoms associated with menopause and other hormonal imbalances, there are also potential risks associated with the therapy. Pharmaceutical compounding offers an alternative that can be tailored to the specific needs of each individual patient, and which can reduce the risk of side effects. If a patient is looking for an alternative to traditional HRT, it is important to speak with a healthcare professional to determine if compounded HRT is a right fit.



  1. “UpToDate.” Evidence-Based Clinical Decision Support System| UpToDate | Wolters Kluwer, https://www.uptodate.com/contents/treatment-of-menopausal-symptoms-with-hormone-therapy. Accessed 19 Jan. 2023.
  2. Gambacciani, Marco, and Marco Levancini. “Hormone Replacement Therapy and the Prevention of Postmenopausal Osteoporosis - PMC.” PubMed Central (PMC), Aug. 2014, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4520366/.
  3. “Menopausal Hormone Therapy and Cancer Risk.” American Cancer Society | Information and Resources about for Cancer: Breast, Colon, Lung, Prostate, Skin, 13 Feb. 2015, https://www.cancer.org/healthy/cancer-causes/medical-treatments/menopausal-hormone-replacement-therapy-and-cancer-risk.html.
  4. Minelli, C., Abrams, K. R., Sutton, A. J., & Cooper, N. J. (2004). Benefits and harms associated with hormone replacement therapy: Clinical decision analysis. BMJ, 328(7436), 371. https://doi.org/10.1136/bmj.328.7436.371 
  5. Cirigliano M. Bioidentical hormone therapy: a review of the evidence. J Womens Health (Larchmt). 2007 Jun;16(5):600-31. doi: 10.1089/jwh.2006.0311. PMID: 17627398.


Sample formula for compounders

Estriol 0.1% Vaginal Cream 100g

Used for estrogen hormone therapy

Ingredients

Estriol powder

Propylene glycol

Xencare HRT Cream Base

Makes 100g

100mg

3mL

Qs 100g

Notes:

This preparation should be prepared in a vertical airflow hood in a biological safety cabinet or barrier isolation technology

Compounding procedure:

  1. Calculate the required quantity of each ingredient for the total amount to be prepared.
  2. Accurately weight and/or measure each ingredient.
  3. Mix the estriol powder with the propylene glycol to form a smooth paste
  4. Geometrically, add the Xenex HRT Cream and bring to final weight, mix well after each addition.
  5. Package and label.

Beyond use date (BUD):

30 days

 

 

 Disclaimer: Xenex Laboratories Inc. has provided the formula and instructions above as a model for educational purposes only on the basis of recognized compendia and texts or references. Xenex Laboratories Inc. takes no responsibility for the validity or accuracy of this information or for its safety or effectiveness, nor for any use thereof, which is at the sole risk of the licensed pharmacist. Adjustments may be needed to meet specific patient needs and in accordance with a licensed prescriber’s prescription. The pharmacist must employ appropriate tests to determine the stability of this suggested formula. Xenex Laboratories Inc., its owners, officers, agents, contractors, affiliates and employees cannot be held liable to any person or entity concerning claims, loss or damage caused by, or alleged to be caused by, directly or indirectly, the use or misuse of the information contained in this suggested formula. In all cases, it is the responsibility of the licensed pharmacist to know the law, to compound any finished product and to dispense these products in accordance with Health Canada and FDA guidelines and appropriate Provincial Drug Schedules and Provincial or Territorial Pharmacy Practice Standards. 

 

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