Progesterone has a job bigger than one symptom.
Prescription micronized progesterone has a defined role in hormone therapy, especially when systemic estrogen and an intact uterus meet.
About 10 minutes. No charge unless your clinician approves.
The hormone with a very specific job.
Progesterone is easy to treat like the supporting actor in hormone therapy because estradiol gets most of the headlines. Clinically, its role can be much more concrete.
For a woman with a uterus using systemic estrogen, progestogen therapy protects the uterine lining from the effects of unopposed estrogen. Micronized progesterone is a body-identical form used in modern menopause care for that purpose. This is not the glamorous part of hormone therapy. It is the part responsible care does not skip.
The capsule is taken at bedtime as directed because drowsiness is a known effect. That timing turns a potential daytime nuisance into a schedule that fits more naturally with the evening, while your provider still pays attention to how you actually respond.
Progesterone also has to make sense inside the rest of the plan. Your clinician reviews your estrogen therapy, uterus status, symptoms, medical history, and risk factors before deciding what role progesterone should have and how it should be prescribed.
Progesterone is not filler beside estrogen. Its core job is uterine protection when systemic estrogen is used with an intact uterus, and its bedtime routine respects how the medication is commonly experienced without promising sleep outcomes.
Read the evidence →For the part of hormone therapy that should never be an afterthought.
Using Systemic Estrogen With a Uterus
Endometrial protection is part of responsible estrogen therapy. You want the progestogen decision handled with the same seriousness as the estradiol prescription itself.
The Bedtime Routine Patient
You prefer a medication schedule that accounts for how the medicine can actually feel. Because micronized progesterone can cause drowsiness, bedtime use may fit more naturally than pretending timing does not matter.
The Perimenopause Patient With Moving Parts
Cycles, symptoms, and the estrogen plan may all be changing at once. You want progesterone considered inside that full picture, not added from a generic checklist.
Dose and schedule are set by a licensed provider against your estrogen therapy, cycle history, and goals, from your full intake. Compounded by a licensed 503A pharmacy and not an FDA-approved drug product.
This might not be the right fit if:
- Known or suspected breast cancer
- Unexplained vaginal bleeding
- Peanut allergy, as some micronized progesterone capsules are prepared in peanut oil
- Active liver disease
- History of blood clots, stroke, or heart attack
Your intake screens for all contraindications. Every candidate is evaluated by a licensed clinician before any prescription is issued. No prescription is issued without clearance.
Progesterone Capsules, prescribed with care.
Compounded by a licensed 503A pharmacy. Prescribed by a licensed provider after clinical review.
- Oral micronized progesterone prescribed as part of an individualized hormone plan
- Taken at bedtime as directed because drowsiness can occur
- Used for endometrial protection alongside systemic estrogen when clinically indicated
- Dose and schedule set from your history and estrogen plan
- Reviewed alongside the rest of your hormone therapy through ongoing care
Prescription issued subject to provider judgment. Results vary. Not a guarantee of outcomes.
*Price reflects a 3 month commitment. Other billing options are shown at checkout.
More in Hormones & Vitality.
Estradiol Gel
Menopause symptoms should not set the pace.
Prescription estradiol gel delivers systemic estrogen through the skin in an adjustable daily format.
Estradiol Patches
Twice weekly. Steady by design.
Prescription estradiol patches provide steady transdermal delivery with a twice-weekly change schedule.
Estradiol Tablet
A familiar form, backed by serious hormone care.
Prescription oral estradiol puts established hormone therapy into a familiar, straightforward daily form.
What the research shows
Adding progesterone cut endometrial hyperplasia from 64 percent to 6 percent.
The detail
The endometrial protection claim rests on a specific randomized trial. In a randomized, double-blind trial, 358 postmenopausal women with an intact uterus were treated for up to 36 months with oral micronized progesterone 200 mg a day for 12 days of each 28-day cycle plus conjugated estrogens 0.625 mg a day, 120 women, conjugated estrogens 0.625 mg a day alone, 119 women, or placebo, 119 women. Endometrial hyperplasia occurred in 6 percent of the combination group against 64 percent of the estrogen-alone group and 3 percent of the placebo group, and atypical hyperplasia in 1 percent against 12 percent and 0 percent.1
An independent trial found hyperplasia rates indistinguishable from placebo.
The detail
An independent trial found the same thing. The Postmenopausal Estrogen/Progestin Interventions trial was a 3-year multicenter randomized, double-masked, placebo-controlled trial in 596 postmenopausal women aged 45 to 64. Women on estrogen alone developed simple hyperplasia in 27.7 percent of cases, complex hyperplasia in 22.7 percent and atypical hyperplasia in 11.8 percent, against 0.8 percent, 0.8 percent and 0 percent on placebo, p less than 0.001. All three estrogen plus progestin regimens, including cyclic oral micronized progesterone 200 mg a day, produced hyperplasia rates indistinguishable from placebo, p equals 0.16, and 34 of 36 women with complex or atypical hyperplasia reverted to normal on progestin therapy.2
The label covers endometrial hyperplasia prevention and secondary amenorrhea.
The detail
The approved indication and the bedtime instruction are label text. Oral micronized progesterone capsules are indicated for prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets, and for secondary amenorrhea. The labeled regimen for endometrial protection is a single daily dose at bedtime, 200 mg orally for 12 days sequentially per 28-day cycle.1
The combination raised coronary, breast cancer, stroke and pulmonary embolism risk.
The detail
The risks that belong to the combination were measured in the Women’s Health Initiative, which randomized 16,608 postmenopausal women aged 50 to 79 with a uterus to oral conjugated equine estrogens 0.625 mg plus medroxyprogesterone acetate 2.5 mg or placebo. Over a mean 5.2 years hazard ratios were 1.29 for coronary heart disease, 95 percent confidence interval 1.02 to 1.63, 1.26 for invasive breast cancer, 1.00 to 1.59, 1.41 for stroke, 1.07 to 1.85, and 2.13 for pulmonary embolism, 1.39 to 3.25.3 The current labeling reports the breast cancer figure by age band: in women aged 50 to 59 the relative risk was 1.21, 0.81 to 1.80, a difference of 6 cases per 10,000 woman-years, against 1.24, 1.01 to 1.53, across the whole 50 to 79 population.1
Over 20 years the two arms diverged on breast cancer, and stayed diverged.
The detail
The two Women’s Health Initiative arms diverged on breast cancer, and stayed diverged. After more than 20 years of median cumulative follow-up across both randomized trials, 27,347 women in total, estrogen plus progestin was associated with higher breast cancer incidence than placebo, 584 versus 447 cases, hazard ratio 1.28, 95 percent confidence interval 1.13 to 1.45, with no significant difference in breast cancer mortality; estrogen alone in women with a prior hysterectomy was associated with lower incidence, 238 versus 296 cases, hazard ratio 0.78, 0.65 to 0.93, and lower breast cancer mortality, 0.60, 0.37 to 0.97. The progestogen component is not incidental to the risk picture.4
What it does not show
Not approved for vasomotor symptoms, sleep, mood, anxiety, cognition or longevity.
The detail
The approved uses are two, and they are narrow. Oral micronized progesterone is approved for prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving conjugated estrogens tablets, and for secondary amenorrhea. It is not approved for vasomotor symptoms, sleep, mood, anxiety, hormone balancing, cognition or longevity. One placebo-controlled randomized trial in 133 healthy postmenopausal women taking 300 mg at bedtime for 12 weeks reported a mean adjusted difference of 4.3 points in a daily vasomotor score against placebo, 95 percent confidence interval 1.9 to 6.6. That is a single trial at a dose above the approved one, not an approved use.15
The trials measured tissue, not how you feel.
The detail
The trials measured tissue, not how you feel. The endpoint in both endometrial trials was endometrial histology from biopsy, curettage or hysterectomy. Those results establish that the uterine lining was protected. They do not establish improved sleep, mood, energy or symptom relief, and they say nothing about outcomes in women who are not taking systemic estrogen.12
The large safety trial used a different progestogen, not micronized progesterone.
The detail
The large safety trial used a different progestogen. The Women’s Health Initiative tested medroxyprogesterone acetate, not micronized progesterone, and the approved labeling states that the relevance of the WHI cardiovascular and breast cancer findings to other doses, other routes of administration or other estrogen plus progestogen products is not known, and that without such data it is not possible to exclude those risks or determine their extent for other products. Any claim that micronized progesterone is the safer progestogen goes beyond what has been randomized.13
The boxed warning came off in 2026.
The detail
That is a relocation, not a reversal. The boxed warning came off, and that is a relocation rather than a reversal. On November 10, 2025 the FDA asked manufacturers of menopausal hormone therapy to remove the cardiovascular disease, breast cancer and probable dementia language from boxed warnings, retaining the endometrial cancer boxed warning only for systemic estrogen-alone products; the revised progesterone labeling was approved on February 12, 2026 and carries no boxed warning. The Women’s Health Initiative findings remain in the body of that label, now reported by age band, and remain contraindications where relevant. No trial cited here tested a compounded capsule.167
- FDA-approved prescribing information, PROMETRIUM (progesterone, USP) Capsules, Acertis Pharmaceuticals LLC, label version 4 published July 2026.DailyMed
- The Writing Group for the PEPI Trial Effects of hormone replacement… JAMA. 1996.
- Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal… JAMA. 2002.
- Chlebowski RT, Anderson GL, Aragaki AK, et al. Association of menopausal hormone therapy with breast cancer incidence… JAMA. 2020.
- Hitchcock CL, Prior JC. Oral micronized progesterone for vasomotor symptoms: a… Menopause. 2012.
- US Food and Drug Administration. FDA requests labeling changes related to safety information to clarify… Drug safety statement, November 10, 2025.FDA
- US Food and Drug Administration. FDA approves labeling changes to menopausal hormone therapy products. Press announcement, February 12, 2026.FDA
Do not use if you have
- Known, suspected, or previous breast cancer
- Unexplained vaginal bleeding
- A prior blood clot, stroke or heart attack
- Liver disease
- A peanut allergy where the capsule is prepared in peanut oil
- A known hypersensitivity to progesterone or to any ingredient of the capsule, of which the peanut oil exclusion is one instance
Serious risks
- Progesterone is in this conversation for a specific reason: estrogen without a progestogen increases the risk of endometrial cancer in a woman who still has a uterus, so unopposed systemic estrogen is not an appropriate plan, and progesterone is the component that addresses it
- Taken together with estrogen over longer use, the combination has been associated with an increased risk of breast cancer, which is part of the tradeoff rather than a footnote to it
- More pronounced dizziness, drowsiness, blurred vision, slurred speech, or difficulty walking has been reported early in therapy, and that is something to report rather than push through
Commonly reported
- Headache
- Breast tenderness
- Low mood
- Dizziness
- Bloating
Because it is an oral capsule
- Oral micronized progesterone can cause transient dizziness and drowsiness, which is why the approved labeling directs that it be taken as a single daily dose at bedtime and cautions about driving or operating machinery
The effects reported most often are listed here. Your provider sets dose and schedule against the rest of your hormone plan and revisits both when that plan changes.
Asked and answered.
You are not charged, and you are not left guessing. Your clinician explains the reasoning and, where it helps, what a better path might look like. Reviews are typically completed in under 24 hours.
Usually not for uterine protection, since the primary reason to pair a progestogen with estrogen is safeguarding the uterine lining. Without a uterus, estradiol is typically prescribed alone. There can be individualized exceptions, and your provider explains the reasoning if your plan is one of them.
Timing depends on clinical review and pharmacy fulfillment. If progesterone is being added to an existing estradiol plan, your provider coordinates the two so the treatment decisions remain connected rather than arriving as unrelated prescriptions.
Drowsiness and dizziness are common considerations, and some women notice mood changes or breast tenderness. Combined estrogen and progestogen therapy over time has been associated with increased breast cancer risk, which your provider discusses in the context of your individual history before prescribing and revisits through care.