Progestelle Ingredients

Progestelle contains coconut oil and USP pharmaceutical grade natural biodentical progesterone. Each ounce of Progestelle contains contains one ounce of coconut oil and 800 milligrams of USP pharmaceutical grade natural progesterone.  

1 ounce of coconut oil 

800 mg of USP bioidentical Natural Progesterone pharmaceutical grade made from yams

Each drop of Progestelle contains 0.6 mg of progesterone.

One dropperful with 2 inches of oil in it contains about 20 mg of progesterone.

A normal dose for a woman may be anywhere between 20 to 60 mg/day of progesterone depending upon the condition being treated. The progesterone starting material TO MAKE THE PROGESTERONE is from yams. THERE IS NO YAM EXTRACT IN PROGESTELLE.

Formulating Progestelle

In 1999, I treated my 70 year old mother for a softball size fibroid in her uterus. She was taking Premarin. Premarin is an estrogen made from pregnant mare’s horse urine. Premarin can stimulate fibroids to grow. I took her off Premarin. The reality, if I had just done this it is likely that her fibroid would've disappeared. I had been reading the book, What Your Doctor May Not Tell You About Menopause by John Lee M.D. He suggested giving progesterone cream to help dissolve fibroids. Fibroids are fed by estrogen. Progesterone opposes the effect of estrogen and will in some cases help the fibroid to disappear. So I gave her progesterone cream he suggested to give his book. I shipped the progesterone cream to my mother in Hawaii. A month later, I called to see how she was doing. She replied that her fibroid had become bigger. I was shocked. I began to check the literature for that particular progesterone cream that had been given to my mother. I found that they had added rosemary to the progesterone cream.  

The company that made the cream said that rosemary was a phytoestrogen. "What was a phytoestrogen?" I asked. 

The company answered, "A phytoestrogen is a plant that acts like an estrogen. We put the phytoestrogen in the progesterone cream for hot flashes and night sweats."[1]

The phytoestrogen in the progesterone cream actually stimulated the fibroid to grow bigger. So, I gave her an alternative progesterone cream and three months the fibroid had shrunk to nothing. Then, I began to investigate this second progesterone cream. I went to go visit my brother in Austin, Texas and went to check the ingredients of the second progesterone cream against the University of Texas material safety and data sheet (MSDS) in their computer system. One ingredient stood out, stearyl konium chloride. The MSDS stated that 3 ml of stearyl konium chloride when taken orally causes fatal convulsions in adults. I was shocked. I calculated that if my mother ate a third of the bottle of the new progesterone cream that I had given her she would die of fatal convulsions. She was absorbing stearyl konium chloride through her skin. I confronted the progesterone cream company. They answered, "Everyone's doing the same thing. This is a standard cream. You go to the three main wholesalers of pharmaceutical compounding supplies and order a bucket of the generic cream. You throw the progesterone in the bucket of cream and mix it. That is your progesterone cream." I was shocked again.

I began to ask all the compounding pharmacist to give me their formulation for progesterone cream. I found that many of the progesterone creams had preservatives that acted like estrogen when put on the skin. For instance, parabens are not carcinogenic, not toxic, well tolerated when taken orally. However, when parabens are put on the skin and absorbed they made rat uteri increase in weight by 30%. This is because whatever is taken orally is first pass 90% inactivated by the liver. However, when you put something on the skin and goes directly into the body and bypasses the liver. So, most people who think that parabens are not estrogenic or do not have estrogenic effects are quoting of the oral estrogen effect data. However, if you're using parabens on the skin you have to use the experimental data that uses parabens on the skin.  When parabens are used on the skin in the concentration used in lotions they will increase rat uterus size by 30%. Then, I began to look at the things of department store. Lotions, shampoos, deodorant, cosmetics, all had chemicals and herbs that were hormone disruptive. Some of these chemicals and herbs mimicked estrogen but did not show up on the hormone test. This is why women have high levels of breast cancer, fibroids, ovarian cysts, and breast cysts. You can read breast cancer and chemical estrogens at breastcancerfund.org.

Then, I began to look at the products in the health food store expecting them to be better. Unfortunately, I found that the vast majority of the products in the health food store also had herbs in them that are considered to be estrogenic. I could not find a progesterone cream that was free of chemicals and herbs that either mimicked estrogen, or blocked progesterone. For an entire year, I tried to formulate a progesterone cream that was free of endocrine disruptors (xenoestrogens or progesterone blockers).  I could not do it.  

A cream is just water and oil mixed together. To keep water and oil mixed together, you have to add an emulsifier. Then, you have to use a thickener. To keep bacteria from growing in the water, you have to have a preservative. Frequently, the emulsifier smells bad, and you have to add some kind of fragrance to cover up the smell of the emulsifier. All these chemicals, even if they are natural frequently seem to have some hormonal disruption capabilities. Finally, after a year I had something. I called up John Lee, M.D. before he passed away. He actually answered the phone and I explained my predicament. I told him the safest thing I could use for emulsifier was soy lethicin. He started yelling at me over the phone.   He didn't like soy.  I apologized. I could not find a satisfactory progesterone cream formulation after an entire year.

Discouraged, I called up Zava, PhD.  Zava, PhD runs ZRT laboratories which does saliva hormone testing. He suggested that I just put progesterone in coconut oil. So, that is what we have.  We have progesterone and coconut oil.  We treat the most severely ill patients.  However, they must avoid all other chemicals or herbs that are hormone disruptive on your skin for it to work. Otherwise, these herbs and chemicals will interact with progesterone and actually cause the disease that we're trying to treat. So, I began to catalog and research which chemicals and herbs mimic estrogen to make my endometriosis patients, breast cyst patients, ovarian cyst patients, PMS patients, fibroid patients worse. The result is an extremely pure formulation of progesterone administration, and a list of chemicals and herbs to avoid, and a list of recommended products that are free of chemicals or herbs that are endocrine disruptors. It does no good to do a hormone test if you are putting an estrogen mimic on your skin that does not show up on the hormone test.

The coconut oil is a special type of coconut oil that remains liquid at room temperature. It is odorless and has a long shelf life. Many consider this type of coconut oil have an indefinite shelf life. It is GMO free. It is soy, corn and wheat free The coconut trees that we get our coconut oil from are not sprayed with pesticides.  However, the coconut oil is not classified as organic. We have a number of patients that are extremely sensitive to pesticides that use Progestelle.  These chemically sensitive patients to pesticides have not been able to feel any pesticides in Progestelle in sixteen years of business as of 2015.

We also have progesterone in organic olive oil and nonorganic grapeseed oil for those patients who are allergic to coconut oil. However, the concentration of progesterone in these two oils is one half the concentration that it is in coconut oil. So, there is more oil used. Some patients do not like so much oil being spread on the skin. However, for those patients, one in 400, that are allergic to coconut oil, olive oil and grapeseed oil are a welcome alternative. From 1999 to 2015, I've had about three patients out of 25,000 that were allergic to progesterone itself, or they were allergic to all three oils.

The USP natural progesterone that we use is purchased from one of the three large wholesale companies that supply compounding pharmacies.  The progesterone is the same progesterone used by your compounding pharmacy. A certificate of analysis accompanies the progesterone. The certificate of analysis is a chemical analysis of the progesterone that that a ship to us specific to that batch of  progesterone shipped to us.  The wholesaler or pharmaceutical chemicals sends a sample of the batch of progesterone to be tested by a third-party analytical chemistry lab. It is this certificate of analysis that accompanies the bulk progesterone. In addition, when the progesterone comes into our facility, we take a sample of the batch of progesterone. This sample of natural progesterone is sent to our own third-party analytical chemistry lab for verification. So, the bulk progesterone that we use is tested twice. The progesterone is tested once by our supplier, and the progesterone is tested once by us. A high performance liquid chromatography test is run on the progesterone and compared to a reference chromatograph of progesterone. This is how we ensure purity and potency of our progesterone that is shipped in our product.

All progesterone is made from either yams or soy. This means that the starting material to make progesterone is either yams or soy. The pharmaceutical factory will take the starting material and then put it into industrial laboratory process to make progesterone. You may read about this progesterone laboratory process here. Our progesterone starting material is from yams. There is no yam extract in Progestelle. There is only USP pharmaceutical grade natural progesterone in Progestelle and coconut oil.

Notes:

1.  Newall C.,et al. Herbal Medicines: A Guide for Health Care Professionals. London: Pharmaceutical Press, 1996; 229-30.