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Progesterone is a progestin hormone, manufactured as oral capsules and other products, that compounding pharmacies prepare in oral, topical, vaginal and other dosage forms.
Progesterone is a hormone made by the ovary and, during pregnancy, the placenta. It belongs to the progestin class. In plain terms, it converts the uterine lining from a growing state to a secretory state and opposes estrogen's effect on that lining. The manufactured oral capsule (Prometrium and generics) contains micronized progesterone chemically identical to ovarian progesterone and is FDA-approved to prevent endometrial hyperplasia in postmenopausal women with a uterus who are taking conjugated estrogens, and to treat secondary amenorrhea. The capsule is formulated in peanut oil. Prescribers may order progesterone compounded when they want a strength that is not manufactured, a preparation free of peanut oil or another excipient, a different base or route, or a combination with another hormone. Compounded progesterone is not FDA-approved and requires a prescription.
The manufactured capsule carries a boxed warning from the Women's Health Initiative studies: estrogen plus progestin therapy should not be used to prevent cardiovascular disease, and the combination studied raised the risk of heart attack, stroke, invasive breast cancer, blood clots, and probable dementia in women 65 and older. The capsule contains peanut oil and must not be used by people with peanut allergy. Do not use progesterone with known or suspected breast cancer, unexplained vaginal bleeding, current or past blood clots, stroke or heart attack, liver disease, or during pregnancy. Dizziness and drowsiness are common; take care when driving. CYP3A4 blockers such as ketoconazole may raise progesterone levels. LactMed reports milk levels are low and no adverse effects are expected in breastfed infants. For sudden leg or chest pain, shortness of breath, vision changes or stroke symptoms, talk to your prescriber or pharmacist.
Progesterone acts at the progesterone receptor to induce secretory transformation of an estrogen-primed endometrium; its reduced metabolites act as GABA-A receptor agonists, which accounts for the sedation seen with oral dosing. Orally, micronized progesterone reaches peak levels within about 3 hours, food increases bioavailability, it is 96 to 99 percent protein-bound to albumin and transcortin, and it undergoes extensive hepatic metabolism to pregnanediol and pregnanolone conjugates with excretion of conjugated metabolites in urine and bile. Oral progesterone undergoes extensive hepatic first-pass metabolism; in a comparative pharmacokinetic study, vaginal and oral administration of the same capsule produced different concentration profiles, with vaginal dosing giving lower peak but more sustained levels. Prometrium capsules are labeled for prevention of endometrial hyperplasia in postmenopausal women receiving conjugated estrogens and for secondary amenorrhea. The NASEM report on compounded bioidentical hormone therapy documents that prescribers have ordered compounded progesterone as creams, gels, capsules, sublingual forms and lozenges, often in combination with estrogens, and concludes that reliable bioavailability data for these preparations are lacking, which the report says makes an accurate characterization of their safety profile impossible. Dosing, cycle schedule and route per prescriber. Monitoring per label: evaluate unexplained bleeding, discontinue if a thromboembolic event or hormone-sensitive malignancy occurs, and consider stopping before surgery with prolonged immobilization. Not a controlled substance.
Compounded at Bayview
Patient guides for the preparations we make most often. Each one is compounded to order and requires a prescription.
For prescribers
Every preparation in our formulary that contains this ingredient. Strength, base and dose form are set by the prescription.
It combines three hormones the body makes naturally: estriol (E3) and estradiol (E2), the two estrogens that make up Bi-Est, plus progesterone. Combining them in a single cream, gel, or troche means one preparation to use instead of two, with each hormone at the strength your provider specifies.
When estrogen is prescribed for someone who still has a uterus, a progestogen is generally added to protect the uterine lining. Combining both in one preparation is a matter of convenience, one product instead of two. Whether a combined product or separate items is right for you is a decision your provider makes.
When estrogen is given to someone who still has a uterus, progesterone is generally added to protect the uterine lining and lower the risk of endometrial (uterine) cancer. Whether and how to prescribe it is a decision your provider makes. It is often paired with an estrogen such as Bi-Est.
Progesterone can cause drowsiness, especially in oral form. That is why oral capsules are often taken at bedtime. Do not drive or operate machinery until you know how it affects you.
Some manufactured progesterone capsules contain peanut oil. Because Bayview compounds each order, progesterone can be prepared without that excipient when your provider orders it, helpful for patients who need to avoid it.
Other salt forms of this molecule, and ingredients commonly compounded alongside it.
This page describes an active pharmaceutical ingredient, not a finished drug product. Bayview Pharmacy compounds preparations containing it only on a prescriber's order for an individual patient.
Compounded preparations are not FDA-approved, and the FDA has not evaluated them for safety, effectiveness, or manufacturing quality. Nothing on this page is a claim that any preparation is effective for any condition.
A valid prescription is required. Availability depends on Bayview's licensure in your state. This page is general information, not medical advice. Discuss your situation with a licensed healthcare provider.
Our pharmacists work with prescribers to build preparations around a patient's dose, form and tolerances. Ask us what is possible with this ingredient.
