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Hormone Replacement Therapy for Women’s Health Month

May is Women’s Health Month, so we’re focusing on hormone replacement therapy in the first of a three-part blog series on women’s health. In June and July, we’ll look at low-dose naltrexone (LDN) and vaginal/pelvic health. 

On the heels of two major research developments on hormone replacement therapy (HRT) in women, now is the perfect time to discuss this treatment option, especially for women who have undergone hysterectomies and oophorectomies or those experiencing menopause. In addition to treating various menopausal symptoms, HRT may have numerous other benefits as well, including improved sleep (1) and protection against bone loss in elderly women (2). 

To maximize these benefits, the optimal HRT combination, dose, regimen, administration route, delivery, and duration should be tailored to each woman. Such a fine-tuned approach to HRT may not be achievable using commercial products, so a compounding pharmacy may be needed to provide HRT formulations that meet the specific needs of individual patients.

HRT safety in women 

In the past, there were many unknowns about the safety of long-term HRT in women, especially those 65 and older. Clinicians often had to rely on their own professional experience and expertise due to a lack of data, but two recent studies have emerged to help prescribers evaluate the safety of HRT in women. 

In the May 2024 issue of Menopause, the authors report the results of an observational study of the electronic health records of more than 10 million women (3). Their results showed no major safety concerns in women using low or medium doses of estrogen (opposed with progesterone/progestins) in women over 65. In addition to their major conclusions, they also found that the route of administration affected the incidence rates of adverse events, with vaginal administration showing fewer incidences of adverse events than oral administration. 

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Another recent study in the May 2024 issue of JAMA reported the results of a 20-year clinical trial by the Women’s Health Initiative, which showed that HRT can be used to treat specific menopausal symptoms, some of which we’ll discuss in this blog post (4). 

Bioidentical hormone replacement therapy versus synthetic hormones

At VLS Pharmacy & New Drug Loft, we use the highest quality bioidentical hormones instead of synthetic hormones, which are often animal-based and have slightly different molecular structures from endogenous hormones. Synthetic hormones are also artificial and have different chemical structures from endogenous hormones, whereas bioidentical hormones are structurally identical to the hormones produced by patients’ bodies. 

We’ll discuss some of our bioidentical hormone replacement therapy (BHRT) options below. A more comprehensive listing can be found on our list of compounded medications for women’s health

Thyroid and adrenal medications

T3 (triiodothyronine) and T4 (thyroxine)

When solving the puzzle of a woman’s hormone health, the first piece that must fall into place is the thyroid. Thyroid hormones, such as T3 (triiodothyronine) and T4 (thyroxine), may decrease either with age or due to other HRT therapies, such as estrogen (5). Administration of oral estrogen (but not transdermal) has been reported to cause a 40 percent rise in the binding protein TBG for thyroid hormones (6). This may cause women with hypothyroidism undergoing estrogen therapy to require more thyroxine (7).

Estrogen and progesterone therapy 

Estrogen and progesterone therapy can be used to manage menopausal or post-menopausal symptoms, including vaginal dryness, UTIs, severe PMS, and low energy. When used alone, estrogen significantly increases the risk of endometrial cancer, so it is used in combination with progesterone or progestin. 

It’s critical to get the dosage right for estrogen therapy: Too high of a dose may increase the risk of cancer, while too low of a dose will not protect against osteoporosis. As a compounding pharmacy, we work with you to ensure your patient is receiving an estrogen/progesterone formulation with a dose tailored to their exact needs. 

Estriol 1 mg/Progesterone 30 mg Vaginal Suppository

When applied as a topical cream, progesterone is not highly absorbed into the bloodstream, so vaginal suppositories are recommended when the goal is to maximize uterine uptake of progesterone and minimize systemic adverse effects (8).

  • Postmenopausal atrophic vaginitis in postmenopausal women (9)
  • For maintaining a pregnancy (10)

0.05% Estriol Vaginal Cream

Estriol may be appropriate for patients who are not candidates for intravaginal estradiol.

  • Vaginal dryness 
  • Vulvodynia

Progesterone 50 mg/mL Oil (or Ethyl Oleate) Injection Solution

  • Infertility (11)
  • Amenorrhea and abnormal uterine bleeding due to hormonal imbalance (12)

Testosterone replacement therapy

Testosterone can be prescribed in perimenopausal and postmenopausal women to boost their sex drive. Studies have shown that testosterone treatment in women with hypoactive sexual desire can be given either testosterone orally or as an intramuscular injection (13).

Topical creams, gels, and ointments

  • Testosterone propionate 2% can be topically applied to treat vulvar dystrophies (14), such as lichen sclerosus (15)

Intramuscular (IM) injection 

  • Intramuscular injections have also been shown to improve sexual function in menopausal women (16)

Sublingual troches 

  • Although it can be part of a long-term HRT, testosterone can also be administered as a single dose to help improve sexual satisfaction (17).

Is testosterone safe for women?

Due to misconceptions about this hormone, many women may be hesitant to begin testosterone HRT (18). However, studies have shown that when administered in low doses, testosterone HRT appears safe in women and shows no association with hypertension or adverse effects on the lipid profile (19). 

Minimizing Adverse Events with Compounded HRT Preparations

Despite recent evidence of their safety, hormones come with the risk of adverse events just like any other medication. A compounding pharmacy can work with prescribers to tailor hormone preparations by:

  • Formulating HRT preparations in a dose and administration route suited to your patient’s specific needs. The dose can be further fine-tuned depending on these needs.
  • Providing transdermal delivery of estrogen via cream instead of a patch to help reduce irritation and improve patient adherence rates (20,21).
  • Removing irritating ingredients (parabens, fragrances, propylene glycol etc.) from topical vaginal HRT preparations and instead using a base that does not induce irritation
  • Removing peanut oil from some commercial progesterone formulations (22).

Why Choose VLS Pharmacy and New Drug Loft?

A woman’s body will undergo many changes throughout her life, either naturally or due to surgeries. HRT offers a way to mitigate many of the symptoms of these processes to help female patients live life to its fullest, especially in their later years. VLS Pharmacy and New Drug Loft are here to make sure that each HRT regimen meets each woman’s specific needs at every stage of her life. 

Regardless of which HRT regimen you determine is optimal for your patient, our pharmacists will tailor the formulation to meet their specific needs, including the dose and administration route. As a 503A pharmacy specializing in sterile and non-sterile compounding, we will support you and your patients by creating safe, individualized, and effective pharmaceutical therapies. All formulations are compounded with high-quality pharmaceutical-grade APIs sourced directly from PCCA, the leader of superior-quality APIs.

 

Please comment below with any thoughts or questions.

Reach out to our team to learn about best practices and to partner with our experts on custom compounded medications for your patients. All medications from VLS Pharmacy and New Drug Loft are prepared in a lab that follows safety and quality standards per our status as a 503A pharmacy.

 

References

  1. Caufriez A, Leproult R, L’Hermite-Balériaux M, Kerkhofs M, Copinschi G. Progesterone prevents sleep disturbances and modulates GH, TSH, and melatonin secretion in postmenopausal women. J Clin Endocrinol Metab. 2011;96(4):E614-623. doi:10.1210/jc.2010-2558
  2. Levy B, Simon JA. A Contemporary View of Menopausal Hormone Therapy. Obstet Gynecol. Published online March 14, 2024. doi:10.1097/AOG.0000000000005553
  3. Baik SH, Baye F, McDonald CJ. Use of menopausal hormone therapy beyond age 65 years and its effects on women’s health outcomes by types, routes, and doses. Menopause. 2024;31(5):363-371. doi:10.1097/GME.0000000000002335
  4. Manson JE, Crandall CJ, Rossouw JE, et al. The Women’s Health Initiative Randomized Trials and Clinical Practice: A Review. JAMA. Published online May 1, 2024. doi:10.1001/jama.2024.6542
  5. Frank-Raue K, Raue F. Thyroid Dysfunction in Peri-and Postmenopausal Women—Cumulative Risks. Dtsch Arztebl Int. 2023;120(18):311-316. doi:10.3238/arztebl.m2023.0069
  6. Shifren JL, Desindes S, McIlwain M, Doros G, Mazer NA. A randomized, open-label, crossover study comparing the effects of oral versus transdermal estrogen therapy on serum androgens, thyroid hormones, and adrenal hormones in naturally menopausal women. Menopause. 2007;14(6):985. doi:10.1097/gme.0b013e31803867a
  7. Arafah BM. Increased need for thyroxine in women with hypothyroidism during estrogen therapy. N Engl J Med. 2001;344(23):1743-1749. doi:10.1056/NEJM200106073442302
  8. Warren MP. Vaginal progesterone and the vaginal first-pass effect. Climacteric. 2018;21(4):355-357. doi:10.1080/13697137.2018.1450856
  9. Chollet JA, Carter G, Meyn LA, Mermelstein F, Balk JL. Efficacy and safety of vaginal estriol and progesterone in postmenopausal women with atrophic vaginitis. Menopause. 2009;16(5):978-983. doi:10.1097/gme.0b013e3181a06c80
  10. Progestin (Oral Route, Parenteral Route, Vaginal Route) Proper Use – Mayo Clinic. Accessed May 2, 2024. https://www.mayoclinic.org/drugs-supplements/progestin-oral-route-parenteral-route-vaginal-route/proper-use/drg-20069443
  11. Devine K, Richter KS, Jahandideh S, Widra EA, McKeeby JL. Intramuscular progesterone optimizes live birth from programmed frozen embryo transfer: a randomized clinical trial. Fertil Steril. 2021;116(3):633-643. doi:10.1016/j.fertnstert.2021.04.013
  12. Progesterone Injection, USP. Accessed May 3, 2024. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a479b395-1e1a-4d2a-8feb-68a15c47225f&type=display
  13. Maclaran K, Panay N. The Safety of Postmenopausal Testosterone Therapy. Womens Health (Lond Engl). 2012;8(3):263-275. doi:10.2217/WHE.12.11
  14. Gadducci A, Facchini V, Del Bravo B, Dell’Arciprete T, Madrigali A, Fioretti P. The topical administration of steroids in the treatment of typical vulvar dystrophies. Clin Exp Obstet Gynecol. 1989;16(1):12-15.
  15. Sideri M, Origoni M, Spinaci L, Ferrari A. Topical testosterone in the treatment of vulvar lichen sclerosus. Int J Gynaecol Obstet. 1994;46(1):53-56. doi:10.1016/0020-7292(94)90309-3
  16. Johansen N, Lindén Hirschberg A, Moen MH. The role of testosterone in menopausal hormone treatment. What is the evidence? Acta Obstetricia et Gynecologica Scandinavica. 2020;99(8):966-969. doi:10.1111/aogs.13819
  17. Tuiten A, Van Honk J, Koppeschaar H, Bernaards C, Thijssen J, Verbaten R. Time Course of Effects of Testosterone Administration on Sexual Arousal in Women. Archives of General Psychiatry. 2000;57(2):149-153. doi:10.1001/archpsyc.57.2.149
  18. Donovitz GS. A Personal Prospective on Testosterone Therapy in Women—What We Know in 2022. J Pers Med. 2022;12(8):1194. doi:10.3390/jpm12081194
  19. Scott A, Newson L. Should we be prescribing testosterone to perimenopausal and menopausal women? A guide to prescribing testosterone for women in primary care. Br J Gen Pract. 2020;70(693):203-204. doi:10.3399/bjgp20X709265
  20. Samsioe G. Transdermal hormone therapy: gels and patches. Climacteric. 2004;7(4):347-356. doi:10.1080/13697130400012239
  21. Hirvonen E, Cacciatore B, Wahlström T, Rita H, Wilén-Rosenqvist G. Effects of transdermal oestrogen therapy in postmenopausal women: a comparative study of an oestradiol gel and an oestradiol delivering patch. Br J Obstet Gynaecol. 1997;104 Suppl 16:26-31. doi:10.1111/j.1471-0528.1997.tb11564.x
  22. Biggio JR. Current Approaches to Risk Assessment and Prevention of Preterm Birth—A Continuing Public Health Crisis. Ochsner J. 2020;20(4):426-433. doi:10.31486/toj.20.0005

 


 

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