Testosterone Pellet Implants for Women

By Paul Savage, MD, FAARM, ABAARM – Founder and Chief Medical Officer | Power2Practice

There are many medical studies coming out about the use of topical testosterone in women. In this post I would like to provide a run-down of the current medical research on a different and superior method of delivering testosterone: pellet implantation.

Pellets, also known as implants, are made up of hormone (such as testosterone) that is pressed into tiny cylinders. The majority of pellets are made by compounding pharmacists and are ideal because they deliver steady, healthy levels of hormone over the period of a few months, as opposed to other delivery methods, which may fluctuate.

Testosterone pellet for treatment of hormone imbalance in women is not experimental, and has been shown to be a superior treatment for treatment of endometriosis, uterine fibroids and PMS; improvement of insomnia, sex drive, libido, hot flashes, palpitations, headaches, irritability, depression, aches, pains, lethargy and vaginal dryness, while also improving bone density and supporting longterm bone density maintenance—without increasing the risk of breast cancer.

Overview

  • Hormone replacement therapy by pellet implantation has been used with great success in the United States, Europe and Australia since 1938 and was found to be superior to other methods of hormone delivery (Greenblatt 49, Mishnell 41, Cantrill 84, Stanczyk 88).
  • Pellets deliver consistent, physiologic levels of hormones and avoid the fluctuations of hormone levels seen with other methods of delivery (Greenblatt 49, Thom 81, Cantrill 84 Stanczyk 88).
  • Estrogen delivered by subcutaneous implants maintains the normal ratio of estradiol to estrone (Thom 81, Stanczyk 88, Owen 92, Cravioto 01).
  • Hormones delivered by the subcutaneous implants bypass the liver, do not affect clotting factors and do not increase the risk of thrombosis (Notelovitz 87, Seed 00).
  • Testosterone delivered subcutaneously by pellet implant is cardiac protective, unlike oral, synthetic methyl-testosterone (Sands 97, Worboys 00).
  • Testosterone delivered by pellet implantation, does not adversely affect blood pressure, lipid levels, glucose or liver functions (Burger 84, Farish 84, Fletcher 86, Barlow 86, Notelovitz 84, Stanczyk 88, Davis 95, 00, Sands 97, Seed 00,Cravioto 01).

 

Menstrual Cycle Affect

  • Testosterone, delivered by pellet implant does not affect the menstrual cycle (Dewis 86) and has been used to treat endometriosis and uterine fibroids (Greenblatt 49).

 

Relief of Menopausal Symptoms

  • Pellets are superior to oral and topical hormone therapy with respect to relief of menopausal symptoms (Staland 78, Cardoza 84).
  • Testosterone implants have consistently been shown to improve insomnia, sex drive, libido, hot flashes, palpitations, headaches, irritability, depression, aches, pains, and vaginal dryness (Staland 78, Thom 81, Brincat 84, Davis 95, 00, Cravioto 01).
  • Testosterone implants in women have been shown to improve lethargy, depression, loss of libido, and hot flashes as well as cardiac and lipid profiles (Farish 84, letcher 86, Sands 97, Seed 00).
  • Testosterone pellet implants have also been used to successfully treat severe pre-menstrual syndrome unresponsive to other forms of therapy, without adverse effects (Dewis84).

 

Bone Density Affect

  • Hormone replacement therapy with testosterone implants is superior to oral and topical (both the patch and gel) hormone replacement therapy for bone density (Savvas 88, 92, Davis 95, Anderson 97).
  • The consistent, adequate levels of testosterone delivered by pellet implant are important in maintaining bone mineral density (Aminoroaya 05) while also being available as a substrate for the production of estradiol (Simpson 02, 03).
  • The pellets not only prevent bone loss but also actually increase bone density (Savvas 88, Studd 90, Garnett 91, Savvas 92, Naessen 93, Holland 94, Studd 94, Davis 95, Anderson 97, Seed 00, Panay 00).

 

Breast Cancer Risk

  • Testosterone delivered by subcutaneous implants does not increase the risk of breast cancer (Dimitrakakis 04, Natrajan 02) as does oral, synthetic methyl-testosterone (Tamimi 06).
  • Pellets do not have the same risk of breast cancer as the synthetic progestins or synthetic Methyl-testosterone. In fact, studies show a reduction in the incidence of breast cancer with the implantation of testosterone pellets, with or without estradiol pellets (Dimitrakakis 04, Tutera 09). Even after over 20 years of therapy with hormone implants, the risk of breast cancer is not increased (Gambrel 06).
  • In breast cancer survivors, hormone replacement therapy with pellet implantation does not increase the risk of cancer recurrence or death (Natrajan 02) compared to estrogen in combination with the synthetic progestins (Habits Trial 04).
  • In a paper published in the journal ‘Menopause’ in 2004, “Breast cancer incidence in postmenopausal women using testosterone in addition to usual hormone therapy,” women were referred for testosterone supplementation for the following indications:
    • Complaints of emotional liability
    • Fatigue and loss of stamina
    • Impaired concentration and memory
    • Breast tenderness
    • Loss of libido
    • Sleep disturbance
    • Muscle weakness
      • Female patients received testosterone implant containing 50-150 mg of testosterone every 5 months in addition to estrogen or progesterone therapy.
      • The addition of testosterone, delivered by pellet implant, was shown to reduce the incidence of breast cancer in women treated with conventional hormone therapy. In women, not on synthetic progestin therapy (which is known to increase the incidence of breast cancer RR 1.69-2.00), the incidence of breast cancer was lower than no hormone therapy.

 

Side Effects

  • Hormone replacement therapy with pellet implantation has an extremely low incidence of side effects (Cardoza 84, Barlow 86, Ganger 89, Pirwany 02) and high compliance rate (Gambrell 06). It has been shown to be extremely effective in the treatment of migraine headaches (Magos 83).

 

Testosterone Pellet Implant Dosing

  • The testosterone implant is licensed in England for women.
  • The routine doses of testosterone delivered by pellet implantation in recent studies are between 75 and 225mg in women.
    • The pharmacokinetics and pharmacodynamics are well established showing that these doses deliver reproducible levels of testosterone for 3 to 5 months.
    • The studies show that pellets have a zero order release rate.
    • Testosterone implants have a near linear release rate.
    • Peak serum testosterone levels with the implants are usually seen at month one.
    • Therapeutic testosterone levels at month one, are expected to be between 250 and 375 ng/dl in females.
    • At approximately 3 months in women, testosterone levels drop at which time symptoms return and the pellets are reinserted. Each individual has their own reproducible levels where symptoms return.
  • The 75 mg testosterone implant is FDA approved in the US (July 13, 1972, male patients). Other doses need to be compounded by trained pharmacists.
  • Testosterone implants have been used in women. Doses used in studies are as low as 50 mg and up to 225 mg. In the United States, common doses are 75, 100, 110mg, 125 and 150 mg.
    • There are minimal side effects at these doses (slight increase in facial hair 20% and mild acne 5%). This may be reduced by lowering the dose, if the patient chooses.
    • If measured, serum treatment levels are elevated above non-treatment levels at month one (Burger 84, Dewis 84, Gambrel 06l, Thom 81, Glaser 09) urine and saliva levels remain normal.
    • There are no signs of androgen excess at these treatment levels.
  • Symptoms return when testosterone levels reach the upper end of endogenous ranges (Burger 84, Glaser, unpublished).

 

In Summary…

Subcutaneous testosterone therapy is safe and effective for both pre- and post-menopausal patients in relieving “menopausal symptoms” along with reducing the risk of breast cancer.

 

About the Author:

Power2Practice EMR for Integrative Medicine

Dr. Paul Savage founded Power2Practice in 2011 and is currently serves as the Chief Medical Officer. He graduated from the University of Michigan Medical School in Emergency Medicine and later earned his board certification in Integrative Medicine at George Washington University.

Since 2004, he has practiced integrative medicine exclusively and is considered by many as one of the world’s foremost authorities in the area of integrative metabolic medicine (IMM), including bioidentical hormone therapy.

Dr. Savage is currently Founder and President of Chicago Integrative Care where he practices medicine. He continues to lecture worldwide and frequently provides expert insights on hormone therapy to major news media.

 

Do you work with compounding pharmacies? Save time with Power2Practice, the first EMR and complete software solution that allows you to create, save, order and re-order your favorite custom compounds with ease. Watch this short video to learn more!

 

If you are interested in learning more about pellet therapy, please visit Sotto Pelle.