Bio-identical hormones are molecules that are the same as the hormones produced by your body, called endogenous hormones. Bio-identical hormone products are usually created from natural sources of plant hormones which match the chemical structure of hormones produced by the human body. The premise is that the body can’t distinguish created bio-identical hormones from the ones the female ovaries produce naturally. The term bio-identical has basically become a catch all phrase for anything that is not a synthetic hormone. However bio-identical hormones can only be truly accurately bio-identical if the hormones mimic those found in the body as well as the natural biological process as well.
WHAT IS BIOMIMETIC HORMONE RESTORATION THERAPY (BHRT)?
The Wiley Protocol is the only biomimetic hormone restoration therapy on the market. Biomimetic hormones, the scientifically accurate term, are derived from plant sources and mimic the natural undulating or wavelike rhythms of the hormone blood levels in a normal menstrual cycle in a healthy young woman. It is this natural rhythm that is missing from all other bio-identical and synthetic hormone replacement therapies.
SO WHAT EXACTLY IS MEANT BY ``THE RHYTHM``?
The body has rhythms that are governed by a master clock that works much like a conductor. It strikes up one section of the body’s orchestra as another quiets down, taking its main cue from light signals in the environment to stay in sync with the 24-hour day. Our body’s hormones surge and ebb to this maestro’s baton, controlling all endocrine function, predominantly a woman’s health for reproduction. It is the circadian clock in our cells that measures one 24 hour spin of the planet. For 28 days the moon tracks the repeat of that cycle, and so does the body.
The Wiley Protocol uses these natural rhythms in nature to establish the proper doses of estradiol and natural progesterone that mimic the natural hormones which would be produced by your body if you were young. The topical creams and their amounts vary throughout the 28 day cycle to restore the hormone levels of a woman in her prime because young women, for the most part, don’t have heart attacks, breast cancer, Alzheimer’s, osteoporosis, or type 2 diabetes.
HOW DOES THE BIOMIMETIC RHYTHM AFFECT YOUR PERIOD?
Women on the Wiley Protocol cycle up to a peak of estrogen and let it fall and then bring it down again for a second smaller peak. We create a progesterone peak on day 21. We have periods (those of us who still have a uterus) and we aim to have them last for five days with a heavier flow on day two and three. We welcome the bleeding because it tells us how the system is working. We know our entire body is getting what it needs. We create the cycle with cream in measured applicators. We rub it on twice a day so it goes into our fat base and wait for our heart beat to pull the hormones into our body in pulses that are characteristic of real functioning endocrinology. We don’t use pills, gels, or sublingual drops.
WHY DID T.S. WILEY DEVELOP THIS TYPE OF HORMONE RESTORATION?
Wiley looked at the various hormone states women have in life; 1) young and cycling 2) pregnant, 3) breastfeeding or 4) declining hormones. She picked number 1) young and cycling, and set out to replicate that state of hormonal health because the other two templates are too hard physically and experimentally to re-create. Wiley wanted natural hormones with natural replacement— real hormone restoration therapy.
If You Are New To The Wiley Protocol
HOW DO I GET STARTED ON THE WILEY PROTOCOL?
Ask your doctor about baseline blood tests to determine your hormonal health before starting. The book, Sex, Lies, and Menopause, written by T.S. Wiley also provides the reasoning and gives references to the science which support the hypothesis. The author encourages you to read the original studies.
WHEN SHOULD I START THE WILEY PROTOCOL IF I AM STILL GETTING MY PERIOD REGULARLY?
If you are still cycling and get period on a regular basis within three days of the moon cycle then, it is fine to move to the Wiley Lunar cycle. If you have a regular cycle then stick with that to start – using the “Personal Calendar” included with your hormones from a Wiley Registered Pharmacy.
HOW DO I KNOW THAT THE WILEY PROTOCOL IS RIGHT FOR ME?
If you have not entered into menopause yet and are peri-menopausal or just having problems with your menstrual cycle, we recommend you consult your doctor as the Wiley Protocol may be right for you.
If you are menopausal and not cycling then it is recommended that you follow the cycles of the moon – Lunar Wiley Protocol. The peak estrogen day twelve (12) is always the full moon.
Blood Tests And Hormone Levels
WHY DO WE NEED TO GET BLOOD TESTS?
Blood tests are done to get a baseline so your healthcare provider can adjust for accuracy. You will also make sure that you are getting into the ranges of healthy young women of 50 years ago who had low levels of diseases of aging. It can be very hard to learn about your symptoms without the help of blood testing.
WHAT ABOUT SALIVA AND URINE TESTING?
Wiley Protocol uses a healthy young woman’s hormone levels as a baseline. There are no baselines for saliva in young women to compare to. Saliva testing tests bi-products and though advocates for saliva testing will argue that it is accurate, the ranges do not apply to the Protocol. Blood testing is the only form of external measurement for the Protocol.
DO I HAVE TO TEST BLOOD EVERY MONTH?
No, it takes a few months for the receptors to come on board so you may wait until the third month to test and then examine the results with your healthcare provider who may change your Protocol.
It is important to look at symptoms too. If you don’t feel well and are showing symptoms of being low on a hormone check with your healthcare provider. Thereafter many women only test periodically. It’s good to test when you feel good to know what that looks like and also when you feel bad. Stress can bring the levels down very fast. The important thing is you don’t want to be hovering in the area below the blood ranges if you have symptoms.
WHEN DO I GET MY BLOOD TESTED?
Day 11 or 12. Day 12 is better to see the estrogen peak. Check both estradiol and progesterone on both days. Day 21 is the progesterone peak but check both progesterone and estradiol. Try to do this about three or four hours after applying your cream. Don’t put cream on the area where the needle will enter.
WHY DO WE NEED TO GET BLOOD LEVELS ON DAYS 12 AND 21?
By testing on days 12 and 21 we can assure ourselves that we are reproducing a normal cycle of a younger woman. Since the Basic Wiley Protocol rarely gets blood levels of more than 300 on Day 12, the blood work is a way of justifying to your healthcare provider that you might need more to meet the upper levels to normal. Day 11 or 12. Day 12 is better to see the estrogen peak. Check both estradiol and progesterone on both days. Day 21 is the progesterone peak but check both progesterone and estradiol. Try to do this about three or four hours after applying your cream. Don’t put cream on the area where the needle will enter. Checking on both days 12 and 21 will show an inverse relationship between the hormones.
WHAT ARE THE OPTIMUM BLOOD RANGES FOR THE PROTOCOL?
*Optimum ranges for women include:
Day 12 estradiol – 350 to 550 pg/mL
Day 12 progesterone should be 1-2
Day 21 progesterone 10 -22 ng/mL.
Day 21 estrogen should be 150-250.
Day 13-14 Female Testosterone 14-76 ng/dL
*Optimum ranges for men include:
T2 between 600-1200. We expect them highest in the Fall, even above this levels.
E2 < 40
E1 < 60 DHT > 250
DHEA’S in the upper half.
As DHT increases E2 dose falls.
Note: These ranges are for a healthy, young 20-25 year old. It is best to use the same lab so the measurement is consistent.
MY INSURANCE DOES NOT COVER BLOOD TESTING. WHERE CAN I GET BLOOD TESTING DONE AT A GOOD RATE?
There are several companies that will sell you lab tests. Order online or call an 800 number, then go to the lab for the blood draw. Find one with a contract lab in your area that also has a good price. At www.lef.org, estradiol and progesterone tests cost $88 in total. They contract with Labcorp – a reputable lab company used by doctors. Directlabs.com or Health-tests-direct.com or Lab-safe.com and Preventive labs.com or Bloodworksusa.com. Or go to www.QuestCares.com for an Uninsured Patient Program. 800.520.7010. Make sure these labs work with your doctor.
WHY DOES THE WILEY PROTOCOL ADVOCATE HIGH DOSES OF HORMONES?
Because Wiley Protocol is biomimetic, it has been designed to mimic the hormone blood levels of a healthy young woman.
HOW DO I KNOW IF THE BASIC WILEY PROTOCOL IS FOR ME?
Many of us need even more hormones than the basic Wiley Protocol provides. It is the starting Protocol to achieve the blood levels that have shown success during the early studies.
The Wiley Protocol Calendar
HOW DO I KNOW WHICH WILEY PROTOCOL CALENDAR TO USE?
Still cycling: If you are still getting a period you will start your Wiley hormones on the first day of your period which is day one of your own cycle and you will be on the personal calendar.
Post-menopausal or if you have had any type of hysterectomy: You will start on day one of the lunar cycle. If you have a uterus you will get your menses back. This could happen the first month or it could take a few months for your uterus to wake up. Once this happens you will now be on your own personal calendar. Should you bleed within three (3) days of the lunar schedule you can stay on it but it is not required.
HOW DO I USE THE NEW FEMALE CALENDARS?
The first row is where you write in the date. The date is the calendar day of the month that you start your hormones. This date must match your day one on either schedule (personal or lunar) in order for the dosing schedule to line up. So for example if Sept 4 is day one of the lunar calendar, you would put Sept 4 in that first box on the line for “date” and follow the lunar calendar, putting day 1 underneath Sept 4. If Sept 10 is the first day of your period then you would put a “10” in that first box and follow the personal calendar, already marked for you. If you are on the lunar schedule you can cross out the personal line and vice versa.
If you are on more than the basic Wiley doses, you would fill in all of your numbers accordingly as the calendar doesn’t have any dosing schedule numbers already recorded for you.
If I’m on the moon or Wiley Lunar cycle, do I use estrogen during the days in between starting with the next cycle?
Yes. You use the base line dose (days 1-5) of estrogen and you never stop the estrogen – the amounts will vary as indicated on the Wiley Protocol packaging label.
The Wiley Protocol Cream Application
CAN I MIX THE WILEY PROTOCOL CREAMS?
No, do not mix the Wiley Protocol estrogen and progesterone creams. It works best when applied separately.
WHY DOES THE WILEY PROTOCOL USE APPLICATORS TO DELIVER THE CREAM? WHY NOT JUST GET BULK CREAM?
The applicators allow for accurate measurement. They also keep the product from being contaminated. Hormone molecules are heavy and may settle in a jar. Registered pharmacies are required to deliver applicators without air bubbles.
WHERE DO I APPLY THE CREAMS?
The estrogen and progesterone hormones creams should be applied on separate limbs and into your fat base. Apply the estrogen to one limb (your arm or inner thigh) and the progesterone to separate limb. Do not mix the creams. Use separate hands for each cream. You also want to put some cream into thin skin, especially while you are building up a deposit in your fat base. Avoid sun damaged areas or abdominal skin. Note that the Registered Pharmacies provide patient instruction sheets with drawings.
WHEN DO I PUT ON THE CREAMS?
Put the creams on two times a day, morning and night unless noted otherwise. (BID)
CAN I PUT ON THE CREAMS, EXERCISE, AND THEN SHOWER?
Ideally the creams should be applied after you exercise or shower. Otherwise wait 40 minutes to shower and two (2) hours to exercise.
DO I ROTATE MY APPLICATION SITES?
It is recommended to use an arm for each migraines, hot flashes, night sweats, palpitations, incontinence, acid reflux, anxiety attacks and sudden sweaty underarms, and then switch arms each month. Don’t jump from area to area and apply the Wiley Protocol on a different area every day. The goal is to create a depot so the hormones will pulse into your body as your heart beats at various rates.
DO I NEED TO BE CAREFUL ABOUT GETTING THE CREAM ON MY PARTNER, CHILDREN OR PETS?
Don’t apply or have close skin contact with others, including your pets, while the cream is still newly applied. So a man and a woman on the Wiley Protocol shouldn’t apply their creams and then have sex. Put on some long sleeves if you put your cream on your arms and then need to pick up a child or pet right after. Don’t worry about washing the clothes.
WHAT IF I AM HAVING RECEPTOR FLUCTUATIONS?
If you are having migraines, hot flashes, night sweats, palpitations, incontinence, acid reflux, anxiety attacks and sudden sweaty underarms (that’s a hot flash) are from fluctuations. Then you can break it up throughout the day to 3 or 4 times by adding the two doses and dividing by 3 or 4. Consult your physician if you are having consistent discomfort.
WHAT IF I HAVE A PROBLEM WITH AN APPLICATOR?
If you push the applicator and cream does not come out initially you may have an air bubble. Just keep pushing the applicator and note what line the cream is at when it dispenses and count from that line. Call your pharmacist and let them know in case they need to provide addition cream so you don’t run out.
Questions about Your Period
DO I HAVE TO HAVE A PERIOD TO BE ON THIS PROTOCOL?
Yes. Your replacement hormones must be high enough to build a uterine lining and then shed it once a month. As we’ve seen in the research, this hormone action of build and shed extends all the way to the myelin sheath encasing the neurons in your brain. If there is no evidence of this happening in your uterus, then it’s not happening in your breasts, brain, or bones, either. The blood levels and a five day bleed with strong bleed on day two or three tell you that you have “virtual fertility”. Mother Nature protects the fertile ones.
WHAT ABOUT OLDER WOMEN WHO HAVE NEVER BEEN ON HRT?
There may be some women in their 70s or 80s that will not be comfortable restarting their periods There are, however, many older women also using the Wiley Protocol. The hypothesis of the Wiley Protocol is that reaching physiologic blood levels of youth will support a healthy cycle where we do see less of the diseases associated with aging.
I HAVEN'T HAD A PERIOD YET, AND I AM IN MY 6TH MONTH ON THE PROTOCOL. WHY HAVE I NOT BEGUN TO CYCLE?
First check to see that your blood tests are in the proper ranges. Are your estrogen levels where they should be? For some women it can take more time to start cycling than others. Remember that each woman is different. For some women it can take more time to start bleeding and to awaken estrogen receptors in the uterus and they usually need more estrogen than the basic Wiley.
HOW LONG SHOULD MY PERIOD LAST?
A sign of good blood levels is that you have a five (5) day bleed with an increase in bleeding on days two (2) and three (3) which lets you know you hit the mark of a good peak on day 12.
I STARTED BLEEDING ON DAY 21. WHAT DOES THAT MEAN AND WHAT SHOULD I DO?
Increase the P-4 by two lines BID *for one day* by placing it on the labia, and if the bleeding doesn’t stop then let the period happen. That means *stop using the progesterone* and start counting your new day 1 from the bleed day. Early bleeding of this nature indicates that there wasn’t enough estrogen present during days one-12 to make a good strong attachment for the lining. Then due to not having enough estrogen during your peak days there was not enough progesterone receptors in place for the progesterone to hold onto the lining. The one day test of increased progesterone to stop the spotting gives the progesterone a chance to “speak louder” for a day, but if we don’t have enough receptors for the progesterone then the lining won’t hold. The early period means we need more estrogen. Increases are made in increments of two lines in the morning and night per month. Symptoms and blood work must be evaluated together. Talk to your Provider and explore the options.
MY PERIOD DIDN'T START THE DAY AFTER I STOPPED USING PROGESTERONE. WHAT SHOULD I DO?
If your period doesn’t start on the day after you stop using progesterone then continue with the base amount of your estrogen and wait for the period to start. When it does start then count that as “day one.” If a period doesn’t come and only came for the first cycle then the context would be somewhat different. A uterus that hasn’t been cycling for 14 years sometimes takes longer for the receptors to reawaken. The first cycle can bring a period because the uterus is shedding a lining that has been accumulating for a long time. If your period doesn’t come by day six, follow the normal escalation of the Protocol. If you are on the lunar calendar you would follow it accordingly. You could stop the progesterone on day 26 of the next cycle to provoke a bleed.
Miscellaneous
IF I START THIS, MUST I DO IT FOR THE REST OF MY LIFE?
No. You use the Protocol as long as you want to avoid the symptoms of aging. If you stop, your internal feedback system will likely revert to where you were when you started. Occasionally women explore the Protocol and stop, then discover they feel better on it and start up again. It often takes about three months to adjust to having a normal rhythm again, just like the start of pregnancy often takes about three months before you really feel great.
WHAT ABOUT TAKING SUPPLEMENTS WHEN ON THE WILEY PROTOCOL?
T.S.Wiley says, “Be careful about supplements. We’ve had cases where women were doing poorly on the Protocol until we asked the right questions and they were taking all sorts of things … herbs, pills, you name it.” Here is a piece of info you may not know – any supplement that has an effect, works across a hormone receptor. That’s one less place for the real hormone to latch on.” See pages 195-196 of Sex, Lies, and Menopause.
DO I NEED TO BE CAREFUL ABOUT GETTING THE CREAM ON MY PARTNER, CHILDREN OR PETS?
Don’t apply or have close skin contact with others, including your pets, while the cream is still newly applied. So a man and a woman on the Wiley Protocol shouldn’t apply their creams and then have sex. Put on some long sleeves if you put your cream on your arms and then need to pick up a child or pet. Don’t worry about washing the clothes.
MY DOCTOR TOLD ME SUBLINGUAL BIOIDENTICALS GET INTO THE BLOODSTREAM AS EFFICIENTLY AS THE CREAM
No. The goal of the Wiley Protocol is to re-create, as much as possible the natural state of hormones of a young woman. That means the hormones need to be rubbed into the thin skin covering a fat pad That creates a depot of hormone in the fat. As the heart beats at various rates and intensity the body will pull the hormone from the fat as needed. In a natural state, hormones have amplitude and pulsing in our bodies. When we re-create this our bodies will read the hormone molecules as hormones. Sublinguals can’t do that. They go right into the blood stream and out again.
WHAT ABOUT USING GELS TO TRANSPORT THE HORMONES?
Gels allow the hormone to enter the blood stream too quickly rather than depositing into the fat base. Two hours later you don’t have the levels you need. This creates fluctuations rather than pulsing which is the hallmark of a hormone. Gels are more akin to taking a drug than replacing your hormone. Hormones in our body are more than just molecules. The manner of replacement is the key to replicating a natural state not just using the same molecules that make up our endogenous hormones.
MY DOCTOR WANTS ME TO USE SUBLINGUAL TROCHES WHEN I FEEL LIKE I NEED MORE ESTRADIOL
Troches are static dosing. They deliver a rapid shot into your system, can create fluctuations, and do not deposit into the fat base. There is nothing close to pulsing with sublingual troches. You body doesn’t hear the information as a hormone so, it is more like taking a drug. With the Wiley Protocol, we are trying to create something as close to nature as possible.
I FOUND THAT IN MY FIRST MONTH, DURING THE ESTROGEN DAYS 1 TO 14, I WAS EXTREMELY SLEEPY.
The estrogen may have few or no receptors to attach to and is pushing the serotonin receptors until it creates its own. This could make you feel sleepy. The progesterone has no receptors yet created by estrogen and so the progesterone is attaching to the Cortisol receptors, which could make you wired. This should decrease from month to month as you follow the Protocol.
HOW DOES THYROID MEDICATION INTERACT WITH THE WILEY PROTOCOL?
In a healthy young woman there is an inverse relationship between estrogen and thyroid. When the estrogen is high, the TSH is low, meaning the body has less need for thyroid. When the estrogen is low the TSH goes up, indicating a need for more thyroid. The thyroid hormone T-3 creates estrogen receptors. When you add in hormones from the outside, then you need to take that into account. There is a Wiley Thyroid cream available that addresses this.
WHAT ABOUT WOMEN WHO HAVE HAD HYSTERECTOMIES? WOULD WE BE GOOD CANDIDATES FOR THE WILEY PROTOCOL?
Our entire bodies need estrogen and progesterone. The cycle supports our bones, our brains, the myelin coating of our nerves, our hearts and many other systems. Many of the women on the Protocol have had various forms of hysterectomies. Some still have ovaries and some do not. Women without these organs tend to need more hormone replacement because of what is missing. A woman without a uterus follows the cycle of the moon (lunar calendar) for her monthly rhythms. She has her day 12 peak on the full moon. Lunar calendars are available at the Wiley Registered Pharmacies.
I WANT TO START THE WILEY PROTOCOL BUT I'M AFRAID MY MIGRAINES WILL GET WORSE. ANY SUGGESTIONS?
Migraines are often a result of not enough estrogen and fluctuating hormones. Women have found relief from migraines for the first time in their lives using the Wiley Protocol. If headaches occur on the Protocol, note the day on your calendar and immediately spread out your dose over the entire day (add morning lines and evening lines together and divide by 4) and apply every few hours for three days. This stops receptor fluctuation.
I'M 41 AND HAVE A FIBROID AND AM HOPING FOR MENOPAUSE SO CAN PUT OFF A HYSTERECTOMY
Fibroids can develop when women don’t have enough hormones to stop cell growth. Estrogen has a positive and negative feedback loop to the brain. When young women with enough hormones within a healthy cycle reach the day 12 peak, the cells hit G1 arrest and stop growing. The estrogen falls and the body waits for progesterone to trigger apoptosis, cell suicide. Women with low levels of hormones and weak rhythm don’t reach the critical peak to activate the mechanisms which promote cell growth, stop cell growth, and trigger cell death. The peaks of each hormone make receptors for the other. Robust cycling in healthy young women keeps the endometrium healthy. Insulin and testosterone are major players in fibroids, too. Blood levels should be checked. Our experience, in most women, is fibroid growth is kept in check by the Protocol and symptoms disappear.
WHAT IF I HAVE FIBROIDS?
Although doctors are hesitant to treat women with fibroids with estrogen replacement we have found in the groups of women on the Wiley Protocol, those who have fibroids, have no serious progression. We see a halt in medium sized tumors and sometimes regression in smaller tumors. Occasionally some women have flares that can be controlled by adapting the dose at that point in the cycle.
WHAT ABOUT CHOLESTEROL? CAN I TAKE STATINS AND BE ON THE PROTOCOL?
Cholesterol is the building block for hormones. Statins are not advisable or contraindicated on the Wiley Protocol. Estrogen is said to lower cholesterol levels*, but this may not be true for women not in ranges. *Source: pg 346 Medical Physiology, Ganong
I HAVE OSTEOPOROSIS AND USE FOSOMAX. CAN I STILL TAKE IT WHEN ON THE WP?
Fosomax and other osteoporosis medicines such as Raloxifene are not advisable, or contraindicated on the Wiley Protocol. Women on the Protocol find their bone density increases positively and osteoporosis is corrected. The hormone rhythms and blood levels support healthy bone metabolism.
DOES THE WILEY PROTOCOL SHOOT FOR A RATIO OF ESTRADIOL TO PROGESTERONE?
The Wiley Protocol does not look for a static ratio of estradiol to Wiley. However, T.S. Wiley advocates achieving an inverse relationship between estradiol and progesterone blood values on day 12 and 21 to help adjust the dose for accuracy. “Day 12’s estrogen and progesterone readings should be inverse to Day 21 for example, Day 12, E-425, P-1.7 versus Day 21, E-150, P-21.”