What is BHRT?
BHRT stands for Bio-Identical Hormone Replacement Therapy. The “B” stands for Bio-Identical, not biosimilar. During the development of a therapeutic project, any modification in the manufacturing process can create slight changes in the structure of the resulting drug, thus creating a “biosimilar.” [McCamish, Clinical Pharmacology & Therapeutics 2012 /p409 A]. The term “Bio-Identical,” as defined by experts from The Endocrine Society, is a compound that has exactly the same chemical and molecular structure as the hormones that are produced in the human body. [Files Mayo Clinic Proceedings 2011 /p674 A]
A simple way to describe hormone imbalance is that it represents any combination of hormone levels that are not within the expected normal range. Because hormones are kept within a certain range to perform specific functions, hormone imbalance can be associated with a variety of symptoms and functional changes in the body.
Hormone imbalance in men and women differs because of the hormones involved and the function of the hormones that are not within the normal range or not functioning properly.
Hormone Imbalance in Men
Testosterone deficiency is present in a percentage of men age 50–69 years and in an even greater proportion of men 70 years of age and older. Unwanted consequences include decreases in: [Little, Current Diagnosis and Treatment 2014 /p8 B]
- Muscle mass and strength
- Bone mass
- Sexual interest and ability to function sexually
- Cognitive function
- They may also experience increases in fat mass. It is unknown, however, whether these changes can all be attributed to declines in testosterone levels or whether there are other contributing factors. [Little, Current Diagnosis and Treatment 2014 /p8 B]
Hormone Imbalance in Women
Decreased estrogen levels represent an important form of hormone imbalance in women. Although in many cases it is the result of a normal physiological change associated with aging, because up to a third of a woman’s life today may occur after menopause, there is a compelling reason to be concerned about its impact on physical, social, and emotional aspects of a woman’s life, including: [Hoffman, “The Mature Woman,” Williams Gynecology 2016 /p1 A]
- Physical symptoms, such as vasomotor symptoms (night sweats, hot flashes and flushes) and vaginal dryness
- Structural changes such as bone loss, skin thinning, fatty replacement of the breast
- Changes in blood lipids
- Atrophy of the bladder and urethra
Optimization in men
A common form of hormone optimization in men is testosterone replacement therapy. This type of therapy is approved for men who have low levels of testosterone related to certain medical conditions. Examples of these conditions include genetic problems, and chemotherapy or infections that have damaged the testicles. [Khera, Journal of Sexual Medicine 2016 /p1794 A]
Optimization in women
Hormone optimization in women usually involves some formulation of estrogen, either alone or with progesterone. As with testosterone therapy, estrogen therapy is guided by certain limitations and restrictions. Hormone therapy with estrogens (with or without progesterone) is indicated only for treatment of vasomotor symptoms and vaginal atrophy and for osteoporosis prevention or treatment. [“The Mature Woman,” Williams Gynecology 2016 /p3 A]
Testosterone is also used in women and may be appropriate treatment for those with depression and fatigue after surgically induced menopause, or in women in whom estrogen therapy hasn’t relieved all symptoms and there is a need to benefit from the effects of testosterone on the endocrine system and sexual function. Testosterone therapy comes in many forms, such as creams, gels, patches or pills. [Glaser, Maturitas 2013 /p231 A]
Types of BHRT
Hormone therapy using testosterone or estrogen + progesterone is available in a wide variety of formulations, including pellets, injections, oral forms, gels, solutions and patches. The available BHRT products in these categories represent a portion of the available treatments.
Re3™ Advanced Pellet Formulation
Pellecome provides BHRT pellets for the most common medical problems associated with endocrine imbalance. The hormones associated with endocrine imbalance include estradiol (estrogen), progesterone and testosterone. Subcutaneous implants have been identified as a convenient and practical method for delivering drugs that provides greater assurance that patients will take the prescribed medication and may have a more predictable therapeutic outcome than other delivery methods. [Lin, AAPS PharmSciTech 2001 /p1 A].
Postmenopausal women may suffer from issues associated with aging and estrogen loss that may negatively affect their health. [Hoffman, “The Mature Woman,” Williams Gynecology 2016 /p1 A]
Hormone therapy is usually prescribed using the lowest effective dose and for only the amount of time that is needed based on clinical judgement and the needs of the individual patient. [“The Mature Woman,” Williams Gynecology 2016 /p3 A] Pellecome’s estradiol pellets are available in the following strengths: 10 mg, 15 mg, 20 mg and 25 mg.
Progesterone is a female steroid sex hormone that is secreted by the corpus luteum to prepare the endometrium for implantation and later by the placenta during pregnancy to prevent rejection of the developing embryo or fetus. It is also the name used for any synthetic steroid resembling progesterone in action.
Progesterone is the human hormone made by a woman’s ovaries. Manufactured Progesterone is plant based and acts the same as what is made in the body, hence “bio-identical”. In hormone replacement therapy, progesterone is combined with an estrogen to lower risks of endometrial cancer in women who still have a uterus. Progesterone may be prescribed daily with estrogen, and this dosing is termed continuous therapy. Pellecome’s progesterone pellets are available in the following strengths: 50 mg, 100 mg and 200 mg.
Testosterone is the main sex hormone (androgen) in men. It is responsible for male physical characteristics. Although it is considered to be a “male” sex hormone, it is present in the blood of both men and women.
Testosterone exerts effects on the male body throughout the life cycle. This process is regulated and stimulated by hormones originating in parts of the brain (the hypothalamus) and the pituitary gland. [Oh, Urological Nursing 2006 /p1 A /p2 A]
A diagnosis of testosterone deficiency may be more likely in men who present with lower than normal testosterone levels and all three of following symptoms: [Khera, Journal of Sexual Medicine 2016 /p1790 A]
- Erectile dysfunction
- Decreased libido
- Decreased frequency of morning erections
Pellecome’s testosterone pellets are available in the following strengths: 25 mg, 50 mg, 100 mg, 200 mg and 300 mg.
All three hormone formulations dissolve and release hormones as well or better than currently available pellets. Tests for testosterone, estradiol (estrogen) and progesterone show no degradation after incorporation into the pellets.
One of the key features of Pellecome’s pellet formulations is that they are manufactured and tested in a regulated manner using rigid quality standards. Pellets and other hormone formulations that are created in a compounding pharmacy may not adhere to the same standards. Thus, what Pellecome provides is a strong measure of predictability and reliability with regard to their manufacturing process and performance once implanted.
Re3™ Advanced Delivery System
The Re3™ Advanced Pellet Delivery System for Men & Women is a novel, patent pending medical device created by a physician with over 20 years experience in Bio-Identical hormone replacement therapy (BHRT) to improve the pellet insertion process – making it easier, safer, and more reliable.
The current procedure most widely used for pellet insertion requires the healthcare provider to clean, autoclave, and reuse the instruments needed for pellet insertion. This method can be cumbersome and expensive and relies on non-standardized procedures at each provider. There are also plastic, single-use kits for pellet insertion, which are not widely used due to poor quality instruments.
Bio-Identical Hormone Replacement Therapy (BHRT) is the therapeutic use of plant-based hormones that are identical on a molecular level with those created by the human body. Hormone pellets are often the preferred method of delivery and have benefits over other formulations, such as creams or orals. Sustained, consistent release of hormones from pellets over time is considered an advantage over the fluctuations that can occur with formulations.
Some healthcare providers prescribe a combination of pellets, creams and/or orals to optimize their patients’ hormones.
Pellet therapy is simple and easy! Pellets are inserted into patients 3-4 times per year. The procedure takes less than 15 minutes.
Patients don’t have to worry about applying creams or taking orals daily so compliance is not an issue.
Every patient and their hormone optimization journey are unique. Within 7-10 days after your pellet insertion, Bio-Identical Hormone Replacement Therapy (BHRT) begins to work. Once the pellets are inserted in the gluteal area, a consistent dose of Bio-Identical hormones enter the bloodstream.
Most patients report some symptom relief in as little as 2-4 weeks, but full optimization may take up to 6 months. Your healthcare provider will customize your particular hormone optimization for you.
Bio-Identical Hormone Replacement Therapy (BHRT) is a treatment for many common and debilitating symptoms associated with aging, which are not traditionally addressed by healthcare providers. Symptoms such as fatigue, stress, foggy thinking, weight gain, loss of sex drive and sleep disturbances are some of the most common complaints. The goal of BHRT is to address the root cause of symptoms by optimizing hormone levels. BHRT is a natural and simple method for addressing hormone imbalance in Men and Women.
Data have shown that Bio-Identical hormone pellet therapy can be successful in treating Men and Women with hormone imbalance.