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 started prescribing Prometrium back in the late 90s, we were all just beginning to understand the nuances of bioidentical hormone replacement. The transition from synthetic progestins to micronized progesterone represented a fundamental shift in how we approach luteal phase support and menopausal hormone therapy.
Prometrium: Natural Progesterone Support for Hormone Balance - Evidence-Based Review
1. Introduction: What is Prometrium? Its Role in Modern Medicine
Prometrium represents the pharmaceutical-grade version of micronized progesterone, identical in molecular structure to the progesterone produced by the human corpus luteum. Unlike synthetic progestins, which are chemically modified to enhance oral bioavailability, Prometrium maintains the natural progesterone structure while utilizing micronization technology to improve absorption. This distinction matters clinically - we’ve seen the differential effects on breast tissue, cardiovascular parameters, and mood profiles between natural progesterone and synthetic alternatives.
In my practice, I typically explain to patients that Prometrium serves as replacement therapy for the progesterone their bodies should be making but aren’t producing adequately. Whether we’re dealing with luteal phase defects in fertility patients, managing perimenopausal symptoms, or creating artificial cycles for frozen embryo transfers, having a reliable, predictable progesterone source has transformed our treatment outcomes.
2. Key Components and Bioavailability Prometrium
The formulation seems straightforward - progesterone in peanut oil - but the manufacturing process makes all the difference. The micronization process reduces progesterone particles to 1-10 microns in size, dramatically increasing the surface area for absorption. Without this technology, oral progesterone bioavailability would be negligible due to extensive first-pass metabolism.
We initially struggled with the variability in absorption until we standardized administration protocols. The peanut oil vehicle isn’t just a filler - it facilitates lymphatic absorption, bypassing some of the hepatic metabolism that would otherwise inactivate most of the dose. Still, only about 5-10% of orally administered Prometrium reaches systemic circulation as active progesterone, which is why dosing seems high compared to endogenous production.
The 100mg and 200mg soft gelatin capsules provide flexibility in dosing, though I find most patients do better with divided dosing rather than single large doses, particularly when we’re aiming for sustained serum levels throughout the 24-hour cycle.
3. Mechanism of Action Prometrium: Scientific Substantiation
Progesterone’s actions are mediated through multiple pathways, not just the classic nuclear progesterone receptors. The metabolite allopregnanolone acts as a potent neurosteroid through GABA-A receptors, which explains the sedative effects many patients experience, especially with higher evening doses.
I remember one particularly instructive case - a 42-year-old lawyer named Sarah who was preparing for embryo transfer. She called me panicked because she felt “drunk” after her evening Prometrium dose. This wasn’t a side effect per se, but rather the expected neurosteroid activity. We adjusted her timing so she took it right before bed, and the sedation became therapeutic rather than disruptive.
The endometrial effects are what we monitor most closely in fertility treatments. Prometrium induces secretory transformation of the estrogen-primed endometrium, creates the uterine environment necessary for implantation, and maintains early pregnancy until the placenta takes over progesterone production around 8-10 weeks gestation.
4. Indications for Use: What is Prometrium Effective For?
Prometrium for Luteal Phase Support
In assisted reproduction, luteal phase defect is almost universal due to supraphysiological estrogen levels and multiple corpus luteum removal during egg retrieval. We start Prometrium either the day after retrieval or day of transfer, continuing through the first trimester. The data clearly shows improved pregnancy rates with progesterone supplementation, though the optimal formulation debate continues.
Prometrium for Secondary Amenorrhea
For women with hypothalamic amenorrhea or PCOS who don’t ovulate regularly, periodic progesterone withdrawal bleeds prevent endometrial hyperplasia. I typically use 200mg nightly for 12 days monthly, which reliably induces withdrawal bleeding while protecting the endometrium.
Prometrium for Perimenopausal Symptoms
The PEPI trial data changed my practice significantly regarding menopausal hormone therapy. Combining estrogen with natural progesterone rather than synthetic progestins appears to offer similar endometrial protection with better lipid profiles and potentially lower breast cancer risk.
Prometrium for Premenstrual Dysphoric Disorder
The timing here is crucial - we use luteal phase dosing only, typically 200-400mg daily from ovulation through menses. The GABAergic effects help with the anxiety and insomnia components of PMDD.
5. Instructions for Use: Dosage and Course of Administration
Dosing varies significantly by indication, which often confuses patients. I create customized tables for each clinical scenario:
| Indication | Dose | Frequency | Duration | Administration |
|---|---|---|---|---|
| Luteal phase support | 200-400mg | 2-3 times daily | Through 10-12 weeks gestation | Vaginal or oral |
| Menopausal HRT | 200mg | Daily or cyclic | Long-term | Oral with food |
| Secondary amenorrhea | 200mg | Daily for 12 days | Monthly cycles | Oral with food |
| PMDD | 200-400mg | Daily luteal phase | 10-14 days monthly | Oral with food |
The administration route matters clinically. Vaginal administration provides higher uterine tissue concentrations with lower systemic levels - the “first uterine pass effect” - while oral dosing gives more consistent systemic exposure. I often use combined routes in high-risk fertility patients.
6. Contraindications and Drug Interactions Prometrium
The absolute contraindications are straightforward - known allergy to progesterone or peanut products (due to the oil vehicle), undiagnosed vaginal bleeding, known or suspected breast or genital tract malignancies, active thrombophlebitis or thromboembolic disorders, and missed abortion.
The drug interactions are where we need to be particularly vigilant. Hepatic enzyme inducers like rifampin, carbamazepine, and St. John’s Wort can significantly reduce progesterone levels, potentially compromising treatment efficacy. I had a fertility patient whose progesterone levels dropped precipitously when she started taking St. John’s Wort for anxiety - we identified it quickly, but it highlighted how susceptible the metabolism is to induction.
During pregnancy, Prometrium is category B - no evidence of risk in humans, and we use it routinely through the first trimester in fertility treatments. In breastfeeding, minimal amounts are excreted in milk, but we generally consider it compatible.
7. Clinical Studies and Evidence Base Prometrium
The evidence base for Prometrium spans decades now. The 2012 Cochrane review of progesterone for luteal phase support in ART cycles included 94 studies and concluded that progesterone administration significantly improves ongoing pregnancy rates. The live birth rate increased from 29% to 45% with progesterone supplementation versus placebo or no treatment.
For menopausal hormone therapy, the Kronos Early Estrogen Prevention Study (KEEPS) gave us valuable insights into cardiovascular effects of different progesterone formulations. Women receiving micronized progesterone had more favorable lipid profiles compared to those receiving medroxyprogesterone acetate.
The Postmenopausal Estrogen/Progestin Interventions (PEPI) trial remains foundational - seven years of data showing equivalent endometrial protection with micronized progesterone compared to synthetic progestins, but with more favorable effects on HDL cholesterol.
8. Comparing Prometrium with Similar Products and Choosing a Quality Product
The bioidentical progesterone market has expanded significantly, with numerous compounded and generic alternatives available. The pharmaceutical-grade manufacturing of Prometrium ensures consistent particle size, purity, and dissolution characteristics that compounding pharmacies can’t always guarantee.
I learned this lesson the hard way with a patient who switched to a compounded progesterone to save money. Her progesterone levels became erratic, and we nearly lost a pregnancy before identifying the formulation inconsistency. Now I emphasize that while bioequivalence studies exist for generic micronized progesterone, the excipients and manufacturing processes do vary.
Compared to vaginal gels like Crinone or endometrin, Prometrium offers the flexibility of oral or vaginal administration, though some patients find the vaginal discharge from the oil base inconvenient. The cost difference can be significant, with Prometrium generally being more affordable than specialized vaginal formulations.
9. Frequently Asked Questions (FAQ) about Prometrium
What is the recommended course of Prometrium to achieve results?
The duration depends entirely on the indication. For fertility treatments, we continue through 10-12 weeks of pregnancy. For menstrual regulation, 12-day monthly courses. For menopausal HRT, continuous or cyclic long-term administration.
Can Prometrium be combined with other medications?
Yes, but we monitor for interactions with hepatic enzyme inducers particularly. Dose adjustments may be needed when combined with drugs that affect progesterone metabolism.
How quickly does Prometrium work after starting?
Endometrial effects begin within 24-48 hours, but full secretory transformation takes about 5-7 days of continuous administration. Systemic effects like sedation occur within hours of oral dosing.
What monitoring is required during Prometrium therapy?
For fertility use, we typically check serum progesterone levels 5-7 days after starting. For long-term menopausal use, annual assessment of endometrial status and routine breast cancer screening.
Are there natural alternatives to Prometrium?
While lifestyle modifications and some supplements can support progesterone production, they cannot replace pharmaceutical progesterone when specific serum levels or endometrial effects are required for medical treatment.
10. Conclusion: Validity of Prometrium Use in Clinical Practice
After twenty-plus years of working with this medication, I’ve come to appreciate Prometrium as one of our most versatile and well-tolerated hormonal agents. The risk-benefit profile favors its use across multiple indications, particularly given the safety advantages over synthetic progestins for long-term menopausal hormone therapy.
The evidence base continues to grow, with recent studies exploring its neuroprotective effects and potential applications beyond reproductive medicine. For now, it remains my go-to progesterone for most clinical scenarios requiring progesterone supplementation.
I’ll never forget Miriam, a 38-year-old teacher who’d had three consecutive miscarriages when she came to my clinic. Her luteal phases were consistently short, and despite adequate progesterone levels by standard assays, her endometrial biopsies showed delayed maturation. We switched her from vaginal suppositories to oral Prometrium 300mg daily, divided dose, and the next biopsy showed perfect synchronization. She carried her next pregnancy to term and sent me a photo of her daughter holding a sign that read “Thanks for not giving up on me.”
Then there was the struggle with our clinic’s standardized protocols - some of my partners insisted vaginal-only administration was superior for fertility patients, while I argued for individualization based on absorption patterns. We eventually compromised by implementing first-cycle monitoring with serum levels and adjusting route based on individual response. The data from our internal review showed significantly better outcomes with this tailored approach.
The unexpected finding came from tracking patient-reported outcomes - women using Prometrium reported better sleep quality and less mid-cycle anxiety compared to those using other progesterone formulations, likely due to the more consistent allopregnanolone production with oral administration. This wasn’t something we’d initially considered, but it’s become part of our patient counseling.
Five-year follow-up data from our menopausal patients on combined estrogen-Prometrium therapy shows better adherence and satisfaction compared to those using synthetic progestins, with equivalent endometrial protection. As one patient told me last week, “I don’t feel like I’m on medication - I just feel like myself again.” That’s the goal, isn’t it?