HormoneFDA ApprovedClinical Trials

Progesterone

About

About Progesterone

Bioidentical progesterone is FDA-approved for use in women and is a key component of female hormone replacement therapy, balancing estrogen's proliferative effects on the uterus and breast. It also has calming, sleep-promoting, and neuroprotective properties via its neurosteroid metabolite allopregnanolone. In optimization medicine it is used in both women and some men for hormonal balance and sleep improvement. Oral micronized progesterone (Prometrium) is the gold standard.

Science

Mechanism of Action

Binds progesterone receptors in the uterus, breast, brain, and vasculature; its metabolite allopregnanolone is a potent positive allosteric modulator of GABA-A receptors, explaining its anxiolytic and sedative properties.

Dosing

Typical Protocol

100–200 mg oral micronized progesterone at bedtime (women on HRT); compounded topical or sublingual forms also used.

⚠ Protocol information is for educational purposes only. Dosing must be determined by a licensed physician based on individual health status and goals.

Regulatory

Legal Status in 2026

FDA Approved

This compound has completed clinical trials and received formal FDA approval for one or more indications. It can be legally prescribed by licensed physicians, filled at any licensed pharmacy, and may be covered by insurance. Off-label use by physicians is also legal. This is the highest level of regulatory clearance available in the US.

Evidence

Evidence Tier

Clinical Trials

Evidence from randomized controlled trials (RCTs) or large observational studies in humans. This is the gold standard — effects have been measured in controlled conditions and results are peer-reviewed and reproducible.