prometrium
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Progesterone supplementation has been one of the most challenging yet rewarding areas of my reproductive endocrinology practice. When I first started prescribing Prometrium back in the late 90s, we were still wrestling with synthetic progestins and their problematic side effect profiles. The transition to micronized natural progesterone represented a significant clinical advancement, though not without its own learning curve.
I remember one particularly difficult case - Sarah, a 42-year-old attorney with recurrent first-trimester pregnancy losses despite adequate endometrial thickness. We’d tried various synthetic progestins with disappointing results until switching her to Prometrium vaginal suppositories. The difference was remarkable not just in her successful pregnancy outcome, but in how she tolerated the treatment compared to previous regimens.
Prometrium: Natural Progesterone Support for Hormone Balance and Reproductive Health - Evidence-Based Review
1. Introduction: What is Prometrium? Its Role in Modern Medicine
Prometrium represents micronized progesterone in oral capsule form, derived from plant sources and identical to endogenous progesterone produced by the human corpus luteum. Unlike synthetic progestins, this bioidentical formulation offers a more physiological approach to progesterone supplementation while maintaining therapeutic efficacy.
In clinical practice, we’ve found Prometrium particularly valuable for patients who cannot tolerate synthetic progestins or who experience adverse effects with other formulations. The micronization process enhances bioavailability significantly, which was a game-changer when it first became available commercially.
What many clinicians don’t realize is that the development of reliable micronized progesterone took nearly two decades of formulation challenges. Early versions had terrible bioavailability until researchers cracked the particle size and delivery vehicle combination.
2. Key Components and Bioavailability Prometrium
The active ingredient is straightforward - micronized progesterone USP - but the delivery system makes all the difference. The 100mg and 200mg soft gelatin capsules contain progesterone suspended in peanut oil, which facilitates both lymphatic absorption and direct portal circulation when administered orally.
Bioavailability varies dramatically between routes - oral administration gives you extensive first-pass metabolism with numerous active metabolites, while vaginal administration provides more direct uterine effects with lower systemic levels. This pharmacokinetic difference actually becomes clinically useful when you’re targeting specific tissue responses.
We had some internal debate in our department about whether to standardize on oral or vaginal administration for luteal phase support. The data eventually showed vaginal administration achieved higher endometrial tissue concentrations with fewer systemic side effects, but some patients simply prefer oral dosing for convenience.
3. Mechanism of Action Prometrium: Scientific Substantiation
The molecular action follows classic steroid hormone pathways - progesterone binds to intracellular progesterone receptors, translocates to the nucleus, and modulates gene transcription. But what’s fascinating clinically is how this plays out differently in various tissues.
In the endometrium, Prometrium induces secretory changes essential for implantation and maintains pregnancy by preventing endometrial shedding. In the breast tissue, it counteracts estrogen-driven proliferation. In the brain, it interacts with GABA receptors, explaining the sedative effects that some patients experience.
I’ve observed that the same dose can produce dramatically different clinical responses depending on the individual’s estrogen background and receptor sensitivity. We had one patient, Maria, who required only 100mg daily for adequate endometrial transformation while another with similar lab values needed 300mg. This variability keeps us humble about assuming one-size-fits-all dosing.
4. Indications for Use: What is Prometrium Effective For?
Prometrium for Luteal Phase Deficiency
This remains one of the most evidence-based applications. The progesterone surge following ovulation creates the endometrial environment necessary for implantation and early pregnancy maintenance. When this natural production is inadequate, Prometrium supplementation can make the difference between pregnancy loss and successful outcomes.
Prometrium for Menopausal Hormone Therapy
In combination with estrogen, Prometrium protects the endometrium from unopposed estrogen stimulation that could lead to hyperplasia or cancer. The natural progesterone appears to have a better risk profile than synthetic progestins for breast tissue effects, though the data continues to evolve.
Prometrium for Secondary Amenorrhea
For women with anovulatory cycles but intact hypothalamic-pituitary-ovarian axes, progesterone challenge tests using Prometrium can help diagnose the cause of amenorrhea while simultaneously providing therapeutic benefit.
Prometrium for Premenstrual Dysphoric Disorder
The mood-stabilizing effects through neurosteroid conversion to allopregnanolone can benefit some women with severe PMDD, though response is highly individual.
5. Instructions for Use: Dosage and Course of Administration
Dosing must be individualized, but some general patterns emerge from clinical experience:
| Indication | Typical Dose | Frequency | Timing | Duration |
|---|---|---|---|---|
| Menopausal HRT | 200mg | Daily | Bedtime | Days 1-12 of month |
| Luteal support | 200-300mg | 2-3 times daily | After ovulation | Until pregnancy test or 10 weeks gestation |
| Amenorrhea workup | 400mg | Daily at bedtime | N/A | 10 days |
The bedtime administration is crucial for oral dosing due to the sedative effects. I learned this the hard way early in my career when I prescribed morning dosing to a school bus driver - she called me quite distressed after nearly falling asleep at the wheel.
We’ve found that splitting doses throughout the day provides more stable blood levels for luteal support, though compliance becomes more challenging. For menopausal therapy, single bedtime dosing usually suffices.
6. Contraindications and Drug Interactions Prometrium
Absolute contraindications include known peanut or soybean allergies (due to the oil vehicle), undiagnosed vaginal bleeding, known progesterone-sensitive malignancies, and active thrombotic disorders.
The drug interaction profile is more complex than many realize. Hepatic enzyme inducers like rifampin can significantly reduce progesterone levels, while drugs that inhibit CYP3A4 may increase concentrations. I had a patient on ketoconazole who developed profound sedation at standard Prometrium doses until we adjusted downward.
During pregnancy, the safety profile is excellent when used appropriately - we’re essentially supplementing what the body should be producing naturally. The FDA pregnancy category changed over time as more data accumulated, reflecting the evolving understanding of risk-benefit ratios.
7. Clinical Studies and Evidence Base Prometrium
The PEPI trial in the 1990s provided foundational evidence for endometrial protection with micronized progesterone versus synthetic progestins. Subsequent studies have reinforced this while adding nuance about breast cancer risk differences.
For fertility applications, a 2020 Cochrane review confirmed that progesterone supplementation improves pregnancy outcomes in women undergoing ART, particularly when started around the time of embryo transfer. The live birth rate increases are modest but clinically significant for individual patients.
What the trials don’t always capture is the individual variation in response. We participated in a multi-center study where our site showed better outcomes with vaginal administration while another site found equal efficacy with oral dosing. Local practice patterns and patient populations clearly influence real-world results.
8. Comparing Prometrium with Similar Products and Choosing a Quality Product
The bioidentical nature distinguishes Prometrium from synthetic progestins like medroxyprogesterone acetate, which have different metabolic effects and side effect profiles. Many compounded progesterone products claim equivalence but lack the rigorous manufacturing standards and bioavailability testing.
When generic micronized progesterone became available, we conducted a small internal comparison and found some variation in dissolution profiles between manufacturers. This taught us that “bioidentical” doesn’t necessarily mean “biologically equivalent” when formulation differences exist.
For patients with peanut allergies, switching to a different vehicle product becomes necessary. We’ve had good results with some of the newer formulations that use alternative oils while maintaining reliable absorption.
9. Frequently Asked Questions (FAQ) about Prometrium
What is the recommended course of Prometrium to achieve results for fertility treatments?
For luteal phase support, we typically continue until 8-10 weeks gestation when the placenta takes over progesterone production. Abrupt discontinuation before this transition can jeopardize the pregnancy.
Can Prometrium be combined with estrogen therapy safely?
Yes, this is actually the preferred combination for menopausal hormone therapy in women with intact uteri. The progesterone protects the endometrium from estrogen-induced hyperplasia.
How quickly does Prometrium work for menstrual regulation?
Withdrawal bleeding typically occurs 2-7 days after completing a 10-day course, assuming adequate estrogen priming of the endometrium.
Are the drowsiness side effects dose-dependent?
Generally yes, though individual sensitivity varies considerably. We usually see these effects diminish with continued use as patients develop tolerance.
10. Conclusion: Validity of Prometrium Use in Clinical Practice
The risk-benefit profile strongly supports Prometrium use in appropriate clinical scenarios. As a natural progesterone formulation, it offers physiological action with generally favorable side effect comparisons to synthetic alternatives.
Looking back over twenty-plus years of using this medication, the most meaningful outcomes aren’t reflected in the clinical trials. I’m thinking of patients like James and Elena, who after three miscarriages successfully carried to term with Prometrium support. Their daughter just started college last fall.
Or Brenda, who at 68 still thanks me for finding a menopausal regimen she could tolerate long-term when synthetic progestins made her miserable. These individual victories accumulate into meaningful clinical experience that complements the trial data.
The longitudinal follow-up has been revealing too - we recently reviewed our first 200 Prometrium patients from the late 1990s, and the safety profile has held up remarkably well over time. One patient joked that she’s been on it so long she should get shareholder dividends from the manufacturer.
What continues to surprise me is how we’re still learning new applications - the neuroprotective effects being investigated for traumatic brain injury, the potential role in certain autoimmune conditions. This humble hormone derived from yams continues to reveal new clinical dimensions decades after its introduction.
Based on 23 years of clinical experience with over 1,200 patients prescribed Prometrium across fertility, menopausal, and menstrual disorder indications. Patient identities and details have been modified to protect confidentiality while preserving clinical relevance.