Understanding the Differences Between Prometrium, Compounded Progesterone, and Progestins
Progesterone. A Series of What is the Truth?
When it comes to hormone replacement therapy for women, particularly regarding progesterone, various delivery options are available. There are troches, triturates, suppositories, creams, gels, and capsules. Two common choices of bioidentical progesterone in capsule form are ‘Prometrium’ and ‘Compounded Progesterone’, both derived from plant sterols called Mexican wild yam and/or soy. The term micronized progesterone refers to progesterone from plant sources finely ground to increase absorption and bioavailability. Prometrium and most compounded progesterone is micronized.
While all bioidentical progesterone aim to alleviate symptoms related to hormone imbalances, their effectiveness and mechanisms can differ significantly depending on the delivery system, dosing, and fillers used. Today’s blog begins by covering the capsule form.
BEWARE of Progestins: Confusion is Propagated Using the word ‘Progesterone’ Synonymously with ‘Progestin’
Progesterone is not a progestin.
Progestin is a lab-made synthetic version of progesterone devoid of many natural properties of a natural/bioidentical progesterone with a different chemical structure. It is considered a “non-identical synthetic hormone”. It is used in birth control pills, IUDs, and for control of menstrual cycles, preventing uterine lining overgrowth and bleeding, and menopause symptoms. Examples of synthetic progestins are medroxyprogesterone (MDA), or norethindrone acetate.
Progestin is often referred to as a progesterone and visa-versa creating confusion. Even GoodRx on their website states “Progesterone is a progestin”. Far from the truth! However, you will see this often. BEWARE. The words progesterone and progestin are often used interchangeably. They are two different products entirely. Some progestins and/or combinations of progestins with estrogen are known for increasing the incidence of breast cancer, high blood pressure, and blood clots. Most birth control pills contain progestins.
Natural progesterone is protective against breast cancer and cardiovascular disease.
As much as the literature, headlines, and article titles will try to lure you to think progestins and progesterone are the same thing and act the same; They are NOT the same! When googling questions about progesterone, make sure you enter ‘bioidentical progesterone’.
Difference between Pharmaceutical Progesterone and Compounded Progesterone?
What is Prometrium?
Prometrium is a brand name for the pharmaceutical medication containing micronized progesterone, a synthetic version of progesterone. The main ingredient is bio-identical to the progesterone produced by the ovaries. It is manufactured in big batches with only two doses, 100 mg and 200 mg. It is the most commonly FDA-approved progesterone being sold in pharmacies since 1998, and is covered by insurance. It is the only natural progesterone capsule sold in the US.
It is FDA-approved and commonly prescribed for various conditions, including:
- Menopausal symptoms
- Irregular menstrual periods
- Endometrial hyperplasia prevention in the uterus
Prometrium is taken orally and is well-studied, with established dosages and guidelines for use. Its efficacy is supported by extensive clinical research, making it a reliable option for many women.
What is Compounded Progesterone?
Compounded Progesterone is ordered as an alternative treatment approach by physicians to customize dosing unique to the individual, to eliminate toxins found in Prometrium, and to decrease allergens for the patient. Because it is made uniquely for the individual, it cannot be studied in big batches which is what is required to get FDA approval. There are no brand names like ‘Prometrium’. It is generic progesterone bio-identical to our own. In summary, it is progesterone customized for an individual to meet individual needs and specifications.
Differences between Regular Pharmacies and Compounding Pharmacies
Very simply,
- Pharmaceutical companies make big batches of identical medications in manufacturing facilities; FDA approved for specific diagnoses.
- Compounding 503B pharmacies can make larger batches of medications specifically for hospitals and large clinic needs, FDA regulated but not FDA approved and must comply with current Good Manufacturing Practices (cGMP) like pharmaceutical manufacturers.
- Compounding 503A pharmacies are geared to patients needing individualized custom medications not commercially available. They are state regulated and must adhere to USP standards for sterile compounding.
- All pharmacies use the same basic ingredient sourced from the same FDA-approved sources called progesterone.
Pharmaceutical company’s product advantage is their production process affords consistency in a product by which studies can be conducted to assess efficacy and side effects with high reliability. Hence, these medications can be and are FDA-approved for a specific diagnosis and can be covered by insurance.
Compounding Pharmacies make individualized medications, and therefore, will never be able to be in large FDA-approved studies making FDA regulations different for compounding companies than Big Pharma companies. Because these medications cannot be FDA approved due to their individuality, insurance does not cover them.
Compounding pharmacies are regulated by the FDA and state agencies. They are held to similarly rigorous, specialized standards as pharmaceutical medications. They are subjected to regular inspections and must use pure, pharmaceutical-grade ingredients made in an FDA registered facility.
Compounded medications are made by hand in a lab vs being manufactured by pharmaceutical manufacturing companies in larger facilities.
Both Prometrium and Compounded Progesterone are sourced from the same base active ingredient, Mexican wild yams and occasionally soy.
How is Progesterone made?
Progesterone is made in a lab whether it be Prometrium or Compounded Progesterone. They are essentially made the same way.
Mexican Wild yam, and to a lesser degree, soy, contain diosgenin, a plant compound some believe can be converted into progesterone in the body. However, this conversion is not straightforward, and the body does not process diosgenin into progesterone effectively.
Diosgenin is chemically converted in a pharmacy lab to create a hormone molecularly identical to progesterone produced by your body, hence, the name bioidentical. To progesterone is added various ingredients to enhance absorption, like peanut oil in the commercially available Prometrium; filler to hold the contents together, and colors for capsule identity. A compounding pharmacy is able to make hypoallergenic progesterone without toxins, specified to particular individual dosing.
Key Differences Between FDA-Approved Progesterone and Compounded Progesterone
- Source and Composition:
Prometrium (progesterone USP): Derived from natural sources but processed synthetically to create a pharmaceutical-grade product. It’s standardized and regulated. Prometrium’s active ingredient is progesterone, a natural hormone bio-identical to human progesterone, meaning it is chemically identical to progesterone of human ovarian origin. It is derived from plant sources (usually yams) and micronized to increase absorption.
Prometrium’s inactive ingredients vary slightly by strength but typically include peanut oil (avoid if allergic), gelatin, glycerin, lecithin (soy) (avoid if allergic), titanium dioxide, with colorants like D&C Yellow No. 10, FD&C Red No. 40, or FD&C
Compounded Progesterone: Made primarily from wild yam extract. Its effectiveness depends on the compounding pharmacy’s methods and the individual formulation. The ability to offer a product free of toxins and allergens is an advantage when considering compounded progesterone.
- Regulation and Approval:
- Prometrium: FDA-approved, ensuring consistent quality and efficacy.
- Compounded Progesterone: Not FDA-approved, meaning there can be variability in potency and effectiveness because it is made by humans, not machines. In addition, different pharmacies compound their products differently
- Both Prometrium, and compounded progesterone made in a 503B pharmacy, are regulated by the FDA.
- Efficacy:
- Prometrium: Backed by clinical studies demonstrating its effectiveness in treating hormone issues and decreasing endometrial hyperplasia.
- Compounded Progesterone: Clinical studies as the REPLENISH study show compounded progesterone can be more efficacious in suppressing endometrial hyperplasia than Prometrium in clinical trials. Efficacy can vary between different compounding pharmacies. Using mainly one compounding pharmacy because of repeated efficacy is prudent.
- Dosage and Administration:
- Prometrium: Comes in two specific dosages with standardized instructions.
- Compounded Progesterone: Can be dosed at any dose based on individual needs, with instructions written for the individual.
Conclusion
When considering hormone replacement therapy, it’s crucial to consult with a healthcare provider to determine the best option for you.
- Prometrium is a well-researched and an effective choice coming in 2 doses only.
- It contains toxins, peanut oil, and soy to which a person may be allergic
- Compounded progesterone is made to an individual’s specification.
- Reliability and efficacy are dependent on the individual compounder and therefore, the efficacy of the same product can be different from one Compounding Pharmacy to another.
- Progestin is NOT progesterone.
- Differences in composition, including toxins and fillers, and efficacy are essential factors to weigh into your decision-making process when choosing which product is best for you.
If you have more questions about hormone therapy or specific treatments, feel free to ask!
Have an awesome day! Dr D