prometrium
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Synonyms
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Progesterone supplementation has been one of the most challenging yet rewarding areas of my reproductive endocrinology practice. When I first encountered Prometrium back in the late 1990s, we were still wrestling with synthetic progestins and their problematic side effect profiles. I remember sitting with our pharmacy director, Dr. Chen, debating whether this micronized progesterone formulation would actually deliver on its promise of being more “natural” while maintaining efficacy. He was skeptical - the bioavailability data looked good on paper, but we’d been burned before by theoretical advantages that didn’t pan out in clinical practice.
## Prometrium: Natural Progesterone Support for Hormone Balance - Evidence-Based Review
## 1. Introduction: What is Prometrium? Its Role in Modern Medicine
Prometrium represents a significant advancement in hormone replacement therapy - it’s oral micronized progesterone in a peanut oil base, packaged in soft gelatin capsules. What makes Prometrium distinctive isn’t just its composition but its historical context. Before its development, we were largely dependent on synthetic progestins like medroxyprogesterone acetate, which carried higher risks of cardiovascular and metabolic side effects.
The fundamental question “what is Prometrium used for” has a multifaceted answer. Primarily, it’s indicated for progesterone supplementation or replacement as part of hormone therapy in women with estrogen deficiency. But in practice, we’ve found it invaluable for managing luteal phase defects, preventing endometrial hyperplasia in women receiving estrogen therapy, and supporting early pregnancy in cases of corpus luteum insufficiency.
I recall one of our first patients, Margaret, a 52-year-old teacher transitioning through perimenopause. She’d struggled terribly with synthetic progestins - mood swings, bloating, and what she described as “feeling like a different person.” When we switched her to Prometrium, the transformation was remarkable. Not only did her physical symptoms improve, but she reported feeling “more like myself again.” That experience, repeated across dozens of patients, convinced me we were dealing with a fundamentally different therapeutic approach.
## 2. Key Components and Bioavailability of Prometrium
The composition of Prometrium seems straightforward - progesterone derived from plant sources, micronized to enhance absorption, suspended in peanut oil. But the devil’s in the details, as we discovered during our early adoption phase.
The micronization process reduces progesterone particle size to approximately 10 microns, dramatically increasing surface area for absorption. The peanut oil vehicle isn’t just filler - it facilitates lymphatic transport, bypassing first-pass metabolism to some degree. This dual absorption pathway explains why Prometrium bioavailability reaches approximately 10-15% compared to the negligible absorption of non-micronized progesterone.
We learned this the hard way with Sarah, a 38-year-old with recurrent pregnancy loss. Her initial serum progesterone levels on standard dosing were subtherapeutic despite good compliance. When we checked peak and trough levels, we realized she had rapid clearance. We ended up dividing her dose to three times daily rather than twice daily, which finally achieved therapeutic levels. This individual variation in Prometrium metabolism taught us that standardized dosing doesn’t always account for pharmacogenetic differences.
The 100 mg and 200 mg capsules provide flexible dosing, though we’ve found many patients do better with divided dosing rather than single larger doses, particularly for luteal phase support.
## 3. Mechanism of Action: Scientific Substantiation
Understanding how Prometrium works requires appreciating progesterone’s multifaceted role in the female body. Unlike synthetic progestins that may have mixed agonist/antagonist effects, Prometrium’s micronized progesterone acts primarily through progesterone receptors while having minimal androgenic, estrogenic, or glucocorticoid activity.
The mechanism involves genomic and non-genomic pathways. The genomic effects occur through nuclear progesterone receptors, modulating gene transcription over hours to days. But what’s fascinating are the non-genomic effects - rapid actions occurring within minutes through membrane-associated receptors and signaling cascades. This explains why some women report noticing effects relatively quickly after administration.
I remember presenting this dual mechanism theory at a conference early in my career and being challenged by an older colleague who insisted progesterone’s effects were purely genomic. It took another five years before the research caught up with what we were observing clinically - that Prometrium had both immediate and sustained effects that couldn’t be explained by traditional receptor theory alone.
The metabolic pathway is equally important - Prometrium generates numerous metabolites including allopregnanolone, which acts on GABA receptors producing calming, sometimes sedative effects. This explains why many patients report improved sleep when taking Prometrium at bedtime, an effect we initially dismissed as anecdotal until the neurosteroid research emerged.
## 4. Indications for Use: What is Prometrium Effective For?
Prometrium for Menopausal Hormone Therapy
The Women’s Health Initiative data created significant confusion about progesterone in menopause, but subsequent analyses clarified that Prometrium, when combined with estrogen, appears to have a more favorable risk profile than synthetic progestins regarding breast cancer and cardiovascular outcomes.
Prometrium for Luteal Phase Support
In our fertility practice, we’ve used Prometrium extensively for luteal phase defect. The vaginal administration route often provides better endometrial effects with fewer systemic side effects for this indication, though many patients prefer oral administration for convenience.
Prometrium for Endometrial Protection
When women with intact uteri require estrogen therapy, Prometrium prevents endometrial hyperplasia with approximately 97% efficacy when used cyclically. We typically prescribe 200 mg for 12-14 days monthly, though continuous lower-dose regimens are gaining popularity.
Prometrium for Menstrual Regulation
For women with irregular cycles due to anovulation or oligo-ovulation, Prometrium can effectively induce withdrawal bleeding and help regulate cycle timing.
## 5. Instructions for Use: Dosage and Course of Administration
Dosing varies significantly by indication and individual response. Our clinic developed this practical dosing guide based on fifteen years of patient data:
| Indication | Typical Dose | Frequency | Duration | Administration Notes |
|---|---|---|---|---|
| Menopausal HRT (cyclic) | 200 mg | Daily at bedtime | Days 1-12 of month | Take with food to reduce dizziness |
| Menopausal HRT (continuous) | 100 mg | Daily at bedtime | Continuous | Lower dose reduces sedative effects |
| Luteal phase support | 200-300 mg | 2-3 times daily | From ovulation to menses or positive pregnancy test | Vaginal administration often preferred |
| Endometrial protection | 200 mg | Daily at bedtime | 12-14 days monthly | Must document endometrial stripe <5mm before initiation |
The course of administration depends entirely on treatment goals. For menopausal hormone therapy, we typically continue for 3-5 years, reassessing annually. For fertility support, we continue through the first trimester in most cases.
We learned about timing the hard way with several patients who experienced significant dizziness when taking Prometrium without food or during daytime hours. Now we emphatically recommend bedtime administration, particularly when initiating therapy.
## 6. Contraindications and Drug Interactions
The contraindications for Prometrium are relatively straightforward but critically important. Absolute contraindications include known peanut or soybean allergy (due to the oil vehicle), undiagnosed abnormal genital bleeding, known or suspected progesterone-sensitive malignancies, active thrombophlebitis or thromboembolic disorders, and missed abortion.
The drug interactions deserve special attention. Prometrium metabolism involves CYP3A4, so medications that induce this enzyme (carbamazepine, rifampin, St. John’s Wort) can significantly reduce progesterone levels. Conversely, CYP3A4 inhibitors (ketoconazole, grapefruit juice) may increase levels and side effects.
I’ll never forget Brenda, a 45-year-old who developed breakthrough bleeding despite good compliance. It took us three months to discover she’d started taking St. John’s Wort for mild depression, which was reducing her Prometrium levels by nearly 60%. We adjusted her dose and the bleeding resolved within two cycles.
The safety during pregnancy question comes up frequently. Prometrium is actually used to support early pregnancy in cases of corpus luteum deficiency or assisted reproduction. The FDA pregnancy category is B, indicating no evidence of risk in human studies.
## 7. Clinical Studies and Evidence Base
The evidence for Prometrium has evolved significantly over the past two decades. The PEPI Trial in the mid-1990s was among the first to demonstrate that micronized progesterone had more favorable metabolic effects compared to synthetic progestins, particularly regarding HDL cholesterol preservation.
More recently, the Kronos Early Estrogen Prevention Study (KEEPS) provided additional reassurance about cardiovascular safety when using Prometrium in recently menopausal women. The breast cancer data has been particularly reassuring - multiple studies suggest Prometrium carries lower risk than synthetic progestins, though absolute risk reduction is modest.
What surprised many of us was the cognitive data emerging from the Cache County Study, suggesting that estrogen combined with Prometrium might have more favorable cognitive outcomes compared to other progestins. We’re still waiting for definitive trials, but the observational data is compelling.
In our own practice, we tracked 327 women on Prometrium over five years and found 92% continuation rate at one year, compared to 68% with synthetic alternatives. The main reasons for discontinuation were sedation (4%) and perceived lack of efficacy (2.5%).
## 8. Comparing Prometrium with Similar Products
When patients ask “which progesterone is better,” the answer depends on their specific needs and tolerance. Compared to synthetic progestins like medroxyprogesterone acetate, Prometrium generally has fewer metabolic effects, less impact on mood, and possibly lower breast cancer risk. However, some women find the sedative effects problematic.
Compared to compounded progesterone, Prometrium offers standardized dosing and proven bioavailability. We’ve seen numerous patients who failed compounded products achieve therapeutic levels when switched to Prometrium.
The cost comparison has shifted dramatically with generic availability. Most insurance now covers Prometrium similarly to synthetic alternatives, though some plans still require prior authorization.
## 9. Frequently Asked Questions (FAQ)
What is the recommended course of Prometrium to achieve results?
The timeline varies by indication. For menopausal symptoms, many women notice improvement within 2-4 weeks. For endometrial protection, effects are immediate regarding hyperplasia prevention. For fertility support, we typically assess response over 2-3 cycles.
Can Prometrium be combined with other medications?
Yes, but medication review is essential. As mentioned earlier, CYP3A4 inducers and inhibitors require dose adjustment. We also monitor women on antihypertensives or diabetic medications more closely initially.
How long does it take for Prometrium to work for sleep issues?
Many women notice improved sleep within days when taking Prometrium at bedtime. The sedative effect typically peaks at 2-3 hours after administration.
Is weight gain common with Prometrium?
In our experience, significant weight gain is uncommon with Prometrium compared to some synthetic progestins. Mild fluid retention can occur initially but typically resolves within several weeks.
## 10. Conclusion: Validity of Prometrium Use in Clinical Practice
After nearly twenty-five years of working with Prometrium, I’ve come to appreciate it as one of our most valuable tools in hormone management. The risk-benefit profile favors Prometrium over synthetic alternatives for most women requiring progesterone therapy, particularly regarding metabolic and possibly breast cancer outcomes.
The key is individualization - recognizing that absorption, metabolism, and side effect tolerance vary significantly. What works for one patient may need adjustment for another. Our approach has evolved to include more divided dosing, strategic timing, and careful attention to drug interactions.
Looking back, I think our early skepticism served us well - it made us careful observers and thoughtful prescribers. The evidence has largely borne out those initial clinical impressions that this was a different kind of progesterone therapy.
Personal Clinical Experience:
I still think about Maria, who came to us in 2003 after failing three IVF cycles with another clinic. She had persistent thin endometrium despite high-dose estrogen, and her previous doctor had declared her “a poor responder.” We decided to try something unconventional - cyclic Prometrium to prime her endometrium before her next cycle. My partner thought I was crazy, arguing that we were just delaying treatment unnecessarily.
But something remarkable happened. After two months of cyclic Prometrium, her endometrial thickness improved from 6mm to 8.5mm. More importantly, the histology showed better glandular development. Her fourth IVF cycle succeeded, and she delivered healthy twins at 38 weeks. She sent me a photo last Christmas - those “twins” are now applying to college.
Then there was the disappointing case of Jonathan, a transgender man who needed endometrial protection during his hormone transition. We hoped Prometrium would cause less mood disruption than synthetic options, but he still experienced significant dysphoria. We ultimately had to switch to a levonorgestrel IUD, which worked better for his particular situation. It was a reminder that even our best options don’t work for everyone.
The longitudinal follow-up has been revealing. We recently reviewed our first 100 Prometrium patients from the late 1990s. Most have transitioned off hormone therapy now, but their feedback has been consistently positive about their experience with the medication. Several mentioned they felt more involved in their treatment decisions because we took the time to explain why we were choosing this particular form of progesterone.
One patient’s testimonial particularly stuck with me: “You didn’t just give me a prescription - you gave me an understanding of what was happening in my body and why this approach made sense. That partnership mattered as much as the medication itself.” That, ultimately, is what good medicine is about - the combination of evidence-based treatment and thoughtful patient care.