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Uses and Benefits of Compounded Progesterone - M

Uses and Benefits of Compounded Progesterone

Reviewed by Michael Hua, Pharm D
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Compounded Progesterone: A Hot Topic for Hormone Replacement Therapy (HRT)

Many health experts continue to look for solutions for menopausal symptoms and hormonal imbalance. Over the years, the interest in a more natural approach to hormone replacement therapy (or HRT) has focused the attention on bioidentical hormones including compounded progesterone.

It is important to recognize that progesterone is a hormone that is essential for the functions of all the systems in a woman’s body. There are progesterone receptors in breast tissues, brain, coronary arteries, bones, GI tract, joints, and of course, in the uterus. What this means is that progesterone plays a huge role in regulating many systems, such as metabolism, sleep cycles, memory, cognition, and sexual function. On a cellular level, progesterone activates a tumor suppressor gene called P53 which is responsible for programmed cell death, also known as apoptosis. This could potentially translate to the use of progesterone in cancer therapy since, in cancer cells, this feature for self-termination has gone awry. Hence, when a woman is deficient in progesterone, the risk for breast, ovarian, and/or uterine cancer increases. Other non-cancer related disease risks associated with progesterone deficiency include breast cysts, uterine fibroids, endometriosis, infertility, miscarriage, and osteoporosis.

The level of endogenous progesterone that is produced naturally in women significantly decreases as menopause approaches, which causes a plethora of symptoms, such as hot flashes, night sweats, weight gain, brain fog and mood changes. Yet, when asked why HRT is important for menopausal women, there still seems to be some confusion as to whether one should use hormones in the treatment of menopause. Let’s shed some light into all the benefits that compounded progesterone can revive for menopausal women.

The Benefits of Compounded Progesterone in Comparison to Synthetic Progesterone

The chemical entity progesterone is produced in the human body, and in order to supplement or restore serum levels of progesterone, the treatment requires the use of the exact same hormone: progesterone. The difficulty lies in the fact that progesterone is not found anywhere in the environment outside of the human body. Therefore, the manufacturing process for progesterone starts with a chemical called diosgenin. This phytosteroid derived from wild yams serves as the basic chemical structure for progesterone, and after several chemical processes in labs, chemists turn diosgenin into the chemical moiety we know as progesterone. Once introduced into the human body, the body cannot differentiate between progesterone produced by a lab or progesterone produced by the human body itself. Hence, we call this progesterone biologically identical, or bioidentical, since it has the exact same chemical and structural make-up as the progesterone produced by our ovaries.

Due to its bioidentical nature, bioidentical progesterone binds harmoniously to its receptors throughout the human body. This same structural unity is not seen when synthetic progesterone-like products, or progestins, bind to progesterone receptors. When such synthetic chemicals enter the system, it can not only activate progesterone receptors but also attach to other cell receptors, thus eliciting unwanted side effects. Research has shown that progestins have higher risks of toxic side effects, such as rashes, itching, blockage of blood vessels, changes to menstrual cycle, jaundice, depression, pre-cancerous changes in the cervix, pulmonary embolism, and thrombophlebitis. On the flip side, natural bioidentical progesterone has shown no toxic profile when tested in animals.

Large-scale clinical studies have shown that administering progestins to menopausal women have resulted in higher risks of breast cancer, heart attack and stroke. One particular study found that when medroxyprogesterone acetate tablets (Provera), a synthetic progestin, were given to monkeys, the “arteries went into spasms so severe that they had to stop immediately and resuscitate the monkeys”1. Cardiovascular disease is the number one cause of death in women, hence precaution needs to be magnified when synthetic hormones are to be recommended for HRT. Moreover, the main failure of clinical trials like the Women’s Health Initiative (or WHI) was the fact that studied subjects were given synthetic progestins which adversely promoted atherosclerotic plaque formation and negated the positive, cardioprotective effects of estrogen on lipids. Thus the results of the WHI trials found that menopausal women who were on estrogen plus progestin therapy had an increased risk of coronary heart disease by 80% during the first year. Furthermore, the Nurse’s Health Study, another large investigation into chronic diseases in women, had also shown that the addition of progestin to estrogen therapy increased the risk of breast cancer up to 67%.

These detrimental findings were all discovered in women receiving HRT regimens with progestins. Why is this significant and how come we cannot correlate these findings to bioidentical progesterone? As mentioned above, natural pogesterone does not exhibit toxic profiles like their synthetic counterparts. It makes sense that a naturally derived hormone which is identical in structure and chemical profile to those produced in the human body would exhibit the same metabolic effects to its endogenous twin. In fact, when progesterone is given in high doses, the only side effect that is seen is pain reduction, a factor of its anti-seizure and anti-tumor properties. Bioidentical progesterone has strong anti-proliferative effects on breast tissues which results in lower breast cancer rates in women with intake of progesterone. Progesterone by itself or in combination with estrogen will inhibit atherosclerotic plaque formation. Also, treatment with progesterone has no negative effect on estradiol-induced protection of coronary arteries.

Compounded Progesterone and their Dosage Forms

Bioidentical progesterone therapies comes in many forms, but it can be separated into two main categories: those produced by pharmaceutical companies and those produced by compounding pharmacies.

The main progesterone products manufactured by pharmaceutical companies are

  • Progesterone in peanut oil softgel capsules (Prometrium)
  • Progesterone in oil for intramuscular injection
  • Progesterone vaginal gel (Crinone)

The progesterone injection and progesterone vaginal gel are mainly indicated in fertility treatments. Therefore, the only FDA approved progesterone product that can be used in the treatment of menopause is Prometrium, which is progesterone in peanut oil capsules. Prometrium is available in only TWO strengths: 100mg and 200mg. This significantly limits the dosing range for women, and furthermore, Prometrium’s formulation in peanut oil restricts access for patients who may have nut allergies.

This is where compounded progesterone preparations can be a useful tool in the treatment of menopause and other conditions associated with progesterone deficiency. Our compounding pharmacy is well equipped to prepare compounded progesterone in varying strengths from 5mg to 300mg in various dosage forms such as troches (lozenges), oral suspension, topical or vaginal creams, slow release capsules, immediate release capsules in nut-free oil, and vaginal suppositories.

Achieving balance of the body first comes from recognizing the importance of a harmonious hormonal system. With this arsenal of compounded progesterone products, Harbor Compounding Pharmacy can provide you with the bioidentical progesterone you need, at the exact dose your body needs to regain hormonal equilibrium. With bioidentical hormones like compounded progesterone, your body gets the defense it needs against chronic diseases associated with aging without the risk of side effects from synthetic hormones.

For efficient, personalized, and affordable HRT, Harbor Compounding Pharmacy in California is the name you can trust. Our natural hormone replacement keeps your health in check while enhancing your life. Contact us at 949-642-0106, and get long lasting health solutions today.

References

  1. Loyd, Allen V. Jr., & Northrup, Christiane (1998). Interview on HRT: Christiane Northrup, MD, FACOG. International journal of Pharmaceutical Compounding, 2(1): 12-17.
  2. Hertoghe, T. (2010). The Hormone Handbook. Luxemburg: SA International Medical Books/Archimedial
  3. Formby B, Wiley TS (1998). Progesterone inhibits growth and induces apoptosis in breast cancer cells: inverse effects on Bcl-2 and p53. Ann Clin Lab Sci., 28(6): 360-9.
  4. Lee, Lita (2001). Progesterone- Absorption and Safety. researchgate.net
  5. Tang, Li., Zhang, Yu, et. Al (2009. Involvement of cyclin B1 in progesterone-mediated cell growth inhbition, G2/M cell cycle arrest, and apoptosis in human endometrial cell. Reproductive Biology and Endocrinology, 7:144 doi:10.1186/1477-7827-7-144

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