Since my book, From Hormone Hell To Hormone Well, was released in the fall of 2004 I get frequent calls and emails from women - and men - who are now convinced that their hormones are out of balance and that their body needs supplementation of human-identical/bio-identical progesterone to bring it back to equilibrium. They want to purchase human-identical/bio-identical progesterone cream with the goal of using it twice daily and, thereby eliminating such unpleasant symptoms as hot flashes, night sweats, mood swings, low libido, headaches and weight gain. The problem is that, when these well-meaning people go to a health food or drug store to purchase over-the- counter (OTC) progesterone cream, they do not always get what they need or what they paid for.

The reason for this discrepancy: there is no regulatory body that oversees the production or standardization of product manufacturing for so- called "natural" products. What this means to the average consumer is that there is great variation among the many OTC progesterone creams on the market today. Some are better than others.

As a physician who specializes in human-identical/bio- identical hormone replacement, I found this out for myself over ten years ago in treating my own patients. Often a saliva test for patient in her thirties or forties who was evidencing some symptoms of hormone imbalance would indicate an initial drop in progesterone levels. Simple transdermal (through the skin) replacement of progesterone would be indicated; as a result, I often recommended that my patient(s) go purchase an OTC progesterone cream product, initiate an application regimen and, then, return to see me in six to eight weeks. Some patients reported great improvement, and even elimination, of their symptoms. Others reported less than satisfying results. It seemed that certain products were more consistently helpful than others.

I suspicioned that the formulation of the different creams was at the root of the problem. I had been a licensed pharmacist before going to medical school so I drew on my background to determine what variables would differentiate one cream from another. I then developed my own formulation of progesterone cream and began to dispense it out of my office. As my patient's medical advocate, I felt better overseeing the mixing or compounding of my own progesterone cream. That way I could insure that my patients received a product that truly was what it said it was: human-identical/bio-identical progesterone. Today I know I made the right decision to not trust my patients' care to the whims of the retail marketplace. Over the last decade, my patients using my OTC progesterone cream have reported optimal and consistent results.

While I can not reveal my exact formula for Dr. Randolph's Natural Progesterone Cream, I can outline some of the critical variables that define its excellence and efficacy. Here goes:

• Dr. Randolph's Natural Progesterone Cream is a human-identical/bio-identical formulation of progesterone. This means that the molecules of progesterone suspended in the cream have exactly the same molecular structure as those produced by the human body. The body recognizes, receives and utilizes these molecules. The parent molecule for progesterone comes from a substance known as diosgenin, which is found in soy or Mexican wild yam. Many products on the market today containing soy or Mexican wild yam claim to be a "natural progesterone"; however, until the diosgenin is converted from its original molecular structure, the body will not recognize it. Consequently, soy or Mexican wild yam it the raw state will not generate the same clinical response.
• Dr. Randolph's Natural Progesterone Cream contains the maximum concentration of human- identical progesterone that can be mixed in an OTC product. Some over creams have a "little" progesterone in their mix but not enough to generate a consistent and positive patient response.
• The progesterone I use in my formula meets the United States Pharmacopoeia gold standards for quality and purity. In addition, I require that the lab I use to produce Dr. Randolph's Natural Progesterone Cream compounds my product under strict guidelines approved by the National Association of Compounding Pharmacists. This is not required by law so not all product manufacturers go to the trouble or expense.
• The progesterone molecule in my cream is incased within a liposomal delivery system. This is critical because, as the many layers of the oily globule of liposome melt away like a snowball, the hormones are dispersed continuously through the skin for up to 12 hours. This means that the underlying issue of hormonal imbalance is eliminated, hormonal balance is restored and my patients have continuous relief of their symptoms throughout the day. In contrast, other OTC progesterone creams are not formulated for sustained release. The fact that all the progesterone in these other OTC creams is immediately absorbed through the skin resulting a quick spike in progesterone levels and a temporary vs. constant relief of symptoms.
• Hormone replacement is a process not a landing. As women (and men) age, hormone levels will continue to shift. Human-identical/bio-identical progesterone alone alleviates many to most symptoms of hormone imbalance for a period of time. When the cream is no longer "working" it usually is a signal that other hormone levels- such as estrogen and testosterone- are beginning to drop. At that time, progesterone replacement alone is not enough. Patients will need to seek out a qualified and knowledgeable physician who can measure hormone levels and, then, prescribe an individualized formulation of human-identical/bio-identical hormone replacement.

Over the years, physician colleagues sometimes question my "merchandizing" my own OTC formulation of human-identical progesterone cream. However, once I explain the wide variations in products on the market today, they realize the benefits of my treating patients with a product I can be confident that meets all the above criteria. Often, they too begin to dispense Dr. Randolph's Natural Progesterone Cream out of their offices to their patients. Doctors like myself realize that, when the goal is treating an underlying hormonal imbalance with OTC progesterone replacement, the real thing will always work better than an imitation or approximation.

Until next time...
Be well.

Dr. Randolph

Featured Product

Dr. Randolph's Natural Progesterone Cream

As a woman enters her mid-thirties and until she is in her late forties, she can be said to be pre-menopausal. A woman in this lifecycle is in her middle reproductive years. It is during these years that the balance of hormones produced by the endocrine system first begins to shift. Progesterone, the "feel good" hormone, is the first hormone to decline and drops 120 times more rapidly than estrogen.

As progesterone begins to decline and estrogen becomes the dominant hormone within a woman's body, symptoms such as PMS, breast swelling, irregular periods, fluid retention, uterine fibroids, reduced libido and migraine headaches can occur. From their mid-thirties on, almost all women are estrogen dominant. In many cases, this condition of estrogen dominance can be neutralized by administering transdermal human-identical progesterone cream. Once the body's optimum hormonal ratio of estrogen to progesterone is restored, most unpleasant symptoms will be eliminated.

Are you a physician who wants to learn more about human-identical hormone replacement therapy and/or natural / complimentary medical products?

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