Pellet Hormone Replacement FAQ

We know that Hormone Replacement Therapy is essential for managing severe menopause (or “manopause!”) symptoms, and hopefully there is an easy way to deliver it, right? Fortunately, there is! IntimMedicine offers an easy outpatient procedure to place a bioidentical hormone pellet under the skin. Outta sight, outta mind, and you get to start living your life again!

What is it?

Pellets are compounded bioidentical hormones for women (our team of experts will determine exactly what’s right for you – the right amount can help you regain your hormonal balance). Pellet therapy is actually FDA approved for men, as well. Pellets are typically naturally occurring hormones that are pressed into a solid, little insert, about the size of a grain of rice.

How does it work?

Your pellet will release a small amount of your hormonal regimen straight into your bloodstream, similar to what your ovaries or testes would normally have produced in your younger years. Research shows that pellets are able to deliver a consistent level of hormones to your body, unlike some creams, gels, or pills which are also compounded. Pellets also reduce the risk of blood clots (venous thrombosis) associated with oral hormone replacement therapy because the hormones released from pellets enter the bloodstream directly and do not cause changes in blood clotting factors made in the liver the way oral medications can. It’s a win-win!

How is it used?

Hormone Replacement Pellets are used like any other Hormone Replacement Therapy to help our bodies regain some of its hormonal balance, which will improve everything from the emotional roller coaster to hot flashes. The pellet is just a convenient delivery method! It’s not for everyone, but getting your hormones “just right” no matter the method is critical.

How long does the procedure take?

It is a quick and painless (with numbing medication) outpatient office procedure. We will insert the HRT pellet right into your hip, abdomen or buttock area, and you’ll be on your way and back to your life!

How long till I see results?

It will only take 7-10 days for you to notice your HRT Pellet working on your symptoms.

How long will my pellet last?

HRT Pellets typically last 3-6 months for men and women.

How can I make an appointment? Call us at 202.293.1000 or email us to set up a consultation appointment with one of our specialists here in Washington, DC. Don’t wait to get back to living your normal life – call us today!

Personalized Care

Any medical treatment should be considered specific to the needs and hormone concentrations of each individual patient. This is why we share our full breadth of knowledge about endocrinology, medical safety, and treatment efficacy in addition to treating gynecologic function and overall wellness.

 

So we were dismayed to read that the U.S. Preventive Services Task Force (USPSTF) final recommendation statement on the use of menopausal hormone therapy in post-menopausal women, citing health risks such as breast cancer, heart attack, dementia, and stroke. The key words are post-menopausal. The USPSTF recommendations did not address the overwhelming evidence that hormone therapy (HT) greatly benefits women who are going through the menopausal transition (aka with menopausal symptoms) and who do not have additional health problems. The USPSTF again failed to highlight the population of women who need hormones the most and are most likely to benefit from taking them (see Part 1 of this two-part blog). We can agree with their statement that women who START on their hormone therapy when they are older than 60, or more than 10 years following their last menstrual period, shouldn’t use hormones for the prevention of most diseases. But it doesn’t apply for the women a decade younger; that is, the patient population most often experiencing the symptoms that need treatment (hot flashes, night sweats, vaginal dryness, painful intercourse, mood swings, etc.). The safest time to use HT is during the so-called “estrogen window,” which is the decade-long time-frame between the ages of 50 and 60, or 10 years from the time of menopause (where menopause is defined as the start of at least 12 consecutive months menstrual period-free.

 

Hormone Therapy (HT) Is Effective for Hot Flashes, Night Sweats, and More

The North American Menopause Society’s most recent position statement (2017) concludes that HT remains the most effective (italics are mine) treatment for hot flashes and night sweats and the genitourinary syndrome of menopause (vaginal atrophy, painful intercourse, recurrent urinary tract infections, etc.), and it has been shown to prevent bone loss and fractures (osteoporosis). The risks of HT differ depending on type, dose, duration of use, route of administration, timing of initiation, and whether a progestogen or progesterone is used. Treatment should be individualized to identify the most appropriate HT type, dose, formulation, route of administration, and duration of use, using the best available evidence to maximize benefits and minimize risks. Also, check-ups with each patient during this time to evaluate benefit should be ongoing.

 

Where the Women’s Health Initiative (WHI) Erred

The WHI hormone studies have increasingly come under fire for the way they were designed, most importantly for the inclusion of women up to age 79, and results reported as if all women are the same. The results of these studies have reverberated through the medical community, causing changes that may have been both too broadly applied and, in some cases, simply incorrect (see commentary by David. L. Katz, MD, MPH, FACPM, FACP on such overgeneralizations. The findings that hormone therapy was putting many women at risk for conditions like breast cancer and cardiovascular conditions caused many women to go off their hormone-replacement therapy “cold turkey” without knowing how to address the consequences and not fully understanding the risks versus rewards. For example, some of the patients in the WHI study were already at increased risk for cancer or cardiovascular disease because of lifelong smoking, being overweight and the age at which they started hormone therapy (> 60 years, and up to age 79). However, otherwise healthy women should be able to use these therapies to ward off the symptoms that affect sleep, mood, sexual health, pleasure, etc.

 

We’ve Done Our Homework

In wanting to help my patients find effective ways to treat their symptoms, I analyzed a database of 13 million patients to investigate whether two forms of estrogen therapy (oral versus transdermal) differed in how patients experienced negative effects, particularly focusing on heart attacks, strokes and deep vein thromboses (blood clots in the veins) (see: Simon JA, Laliberté F, Duh MS, Pilon D, Kahler KH, Nyirady J, Davis PJ, Lefebvre P. Venous thromboembolism and cardiovascular disease complications in menopausal women using transdermal versus oral estrogen therapy. Menopause. 2016 Jun; 23(6): 600-10). I concluded that patients who used transdermal estrogens had significantly fewer blood clots in their veins, pulmonary emboli, and heart attacks than those who took an oral estrogen (i.e., pills). Stroke risks were also slightly lower for transdermal estrogen users.

 

I used this information to hypothesize just how different the WHI results would have been had that study used transdermal estradiol and micronized progesterone (see: Simon JA. What if the Women’s Health Initiative had used transdermal estradiol and oral progesterone instead? Menopause. 2014 Jul; 21(7): 769-83.). Those investigations showed that HT type, dose, formulation, route of administration, and duration of use can be tailored to maximize benefits while reducing or eliminating risks. “One size doesn’t fit all,” as the USPSTF suggested.

 

Key Points

  • HT benefits in early menopausal women include reduced coronary heart disease and all-cause mortality.
  • Randomized trials in women initiating HT after age 60 have shown benefit primarily for osteoporosis and fracture but overall increased harm.
  • Reassessment of clinical trials in women initiating HT treatment close to the onset of menopause and newer studies and meta-analyses now show benefit and rare risks.
  • More studies show benefit with estrogen alone than with estrogen plus progestogen.
  • No available medication except HT has demonstrated prevention of osteoporotic fractures in women not previously identified as having osteoporosis.
  • The effects of reduced cardiovascular disease and mortality in women initiating therapy around menopause (the “estrogen window”), and the beneficial effects of HT on the skeleton at any age, together suggest a role for hormone-replacement therapy in disease prevention.

 

Stop Suffering, Start Living

Please contact our office at (202) 293-1000, and make an appointment to get your questions answered and determine the best course of HT treatment that is specifically tailored to you.

We unequivocally support the use of menopausal hormone therapy to mitigate menopause symptoms and prevent disease for a variety of patients. Let’s review the facts of the case. THIS IS NOT FAKE NEWS!

 

When our institutions fail us, it’s time to openly and directly say so. No, this is not a political rant. I’m talking about the United States Preventative Services Task Force (USPSTF), a well-meaning, highly educated group of 12 so-called experts (no endocrinologists, no reproductive endocrinologists, and no menopausal specialists), consisting of two pediatricians, a PhD specialist in health management and public policy, four internists, four family physicians, and our token Ob/Gyn (who isn’t a menopause or hormone therapy expert). Yes, this is the same group (some different players) who recommended every-other-year mammography — and you may remember the backlash and public outcry over that suggestion. (FYI, the major organizations in women’s healthcare didn’t accept that recommendation.)

 

Well, this group is at it again, this time over postmenopausal hormone therapy. Last month (December 2017), the group gave a “D” recommendation for the use of postmenopausal hormone replacement therapy for disease prevention in both naturally menopausal women and women who have had a hysterectomy. A “D” recommendation means: recommends against the use of combined estrogen and progestin (in women with a uterus) or estrogen alone (in women who had a hysterectomy) for the primary prevention of chronic conditions in postmenopausal women. You can read their recommendations for yourself.

 

So, what happened? First, let’s be clear. Experts looking at the same scientific information can disagree on its meaning. But that’s not what happened here. I know this because a real group of menopause and hormone therapy experts replied to the draft recommendations of the USPSTF, attempting to explain the errors of their draft recommendations (see: Langer RD, Simon JA, Pines A, Lobo RA, Hodis HN, Pickar JH, Archer DF, Sarrel PM, Utian WH. Menopausal hormone therapy for primary prevention: Why the USPSTF is wrong. Menopause. 2017 Oct; 24 (10):1101-1112. doi: 10.1097/GME.0000000000000983., Or Langer RD, Simon JA, Pines A, Lobo RA, Hodis HN, Pickar JH, Archer DF, Sarrel PM, Utian WH. Menopausal hormone therapy for primary prevention: Why the USPSTF is wrong. Climacteric. 2017 Oct; 20(5): 402-413. doi: 10.1080/13697137.2017.1362156. Epub 2017 Aug. 14.).

 

These two publications are essentially the same. One was meant for the U.S. audience of menopause and hormone therapy experts, the other for the international menopause and hormone therapy audience. These same recommendations were sent to and received by the USPSTF during their comment period. Nothing from our suggestions was incorporated into the USPSTF documents. One conclusion could be that the USPSTF didn’t care, they had their minds made up, and no amount of scientific information was going to change their opinion. That’s not what happened, in my opinion.

 

The USPSTF opted to do two things to support their forgone conclusions:

  1. They so severely limited the evidence they were willing to consider that they made their judgement based only on the evidence in support of their opinion
  2. They made simplified judgments to apply to every menopausal woman as if they were all the same.

 

This first tactic is prime territory for every lawyer. You define the evidence in such a limiting way as to exclude all evidence not in support of your client. The USPSTF, by excluding so much of the scientific information available, was left with only a few important studies … the usual suspects, the Women’s Health Initiative (WHI) being so large and all encompassing, that it overwhelmed any analysis of the other studies considered.

 

The second tactic, treating all menopausal women as if they were the same, fits well into tactic 1, since the WHI Investigators initially reported on their study “overall” (Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women’s Health Initiative randomized controlled trial. Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women’s Health Initiative Investigators. JAMA. 2002 Jul 17; 288(3): 321-33.), lumping together women aged 50 through 79 as if they were all the same. And that was 15 years ago (prehistoric in scientific years).

 

These two errors in judgment are elegantly summarized by David. L. Katz, MD, MPH, FACPM, FACP who published another paper showing that NOT taking estrogen therapy following a hysterectomy actually resulted in a minimum of 18,601 — and as many as 91,610 postmenopausal women — dying prematurely because of the avoidance of estrogen therapy (ET) over a 10-year span, starting in 2002. Prevention of death is what I would call the ultimate prevention of disease. (See: The mortality toll of estrogen avoidance: an analysis of excess deaths among hysterectomized women aged 50 to 59 years. Sarrel PM, Njike VY, Vinante V, Katz DL. Am J Public Health. 2013 Sep;103(9):1583-8. doi: 10.2105/AJPH.2013.301295. Epub 2013 Jul 18.)

Upon hearing a cancer diagnosis a person’s world changes immediately and forever. The person becomes a patient. The patient has to make myriad decisions about treatment plans, and the possibility of surgery, radiation, and chemotherapy. These treatments, while life-saving, are also life-altering. The side effects can modify body image, reduce or end fertility, change sexual identity and sexual function. Approximately 60 percent of cancer survivors have long-term sexual dysfunction. Oncology teams (who may focus more on the life-saving aspects of care) aren’t always taking the time to discuss fertility or sexual health matters as much as they should. But the good news is that our practice can help save a women’s eggs, or a man’s sperm for future use; mitigate and reverse most hormonal changes, and starting in September, we will also offer treatment for men with urological or sexual complaints in our practice. Our newest colleague, Rachel S. Rubin, MD, is specially trained to treat hormonal and sexual dysfunction in both men and women.

Talking about sexual health outside of the bedroom, in the office of a compassionate physician is key to holistic wellness. The emotions of being a cancer survivor can be overwhelming in and of themselves, but to add infertility or sexual dysfunction to the list of health issues can be daunting. We’re here to help you get back on track.

For Men
Following prostate cancer treatment, for example, the ability to have and maintain an erection becomes difficult and for some men, impossible, without help from a medical practice such as ours. Many men may not feel comfortable talking about these intimate issues, but there is help. Our compassionate and caring staff can help men who experiene treatable symptoms. It’s not just about physical symptoms, cancer affects sexual identity and when men are unable to perform as they could prior to cancer treatment, it can have a serious and detrimental effect on one’s psyche. Getting the courage to seek help is the first step to getting back to the “new normal.”

For Women
Breast cancer, when surgery is required, may alter a woman’s body and can hinder sexual identity and function. Breasts, once part of the sexual experience for both partners, are no longer the same. Even when reconstructed, the breasts may feel different, lack the pleasurable sensitivity they once had, or might even be painful and distracting. Sensation might even be completely gone. Partners may also feel hindered by the feeling of the new breasts. This can be uncomfortable for both partners. With any cancer treatment (i.e. chemotherapy, surgical removal of the ovaries or even hysterectomy) a patient may find herself in early/premature menopause with hot flashes, night sweats, disturbed sleep and weight gain. This is also accompanied by vaginal dryness, and pain with genital touching or intercourse. There are options to help enhance the sexual experience that we have available at the office, and that are not available anywhere else.

A wonderful Newsweek article about these issues does a deeper dive from both the patient and physician perspective that we welcome you to read for additional information.

If you are just starting cancer treatment, going through it, or are in the post-treatment phase and are facing future or current fertility concerns, hormonal deficiencies, or sexual dysfunction, we can help. Please call our office at (202) 293-1000 to make an appointment with one of our caring and compassionate members of Dr. James A Simon’s team.

The postcoital feeling of deep connection, known as the “afterglow” is something couples can rely on to continue for a long time after the actual sexual encounter, according to a new report. The title, “Quantifying the Afterglow” published in Psychological Science, may sound like scientists are breaking it down beyond an emotional and physical connection, and although it is, that warm feeling (aka “the warm fuzzies”) is also physiological and has an evolutionary purpose—strengthening pair bonding. When the sex act concludes with fireworks (i.e., orgasm), how long do the sparks reverberate? Researchers sought to find that out by looking at data of two studies on newlyweds.

Spouses reported their daily sexual activity and sexual satisfaction for 14 days and happiness in marriage at baseline and 4 or 6 months later. It turns out that sexual satisfaction remained elevated about 48 hours after sex, and spouses experiencing a stronger afterglow reported higher levels of marital satisfaction both at baseline and over time.

Sex is Romantic, but also Scientific
Fast forward from being newlyweds to new parents. Overwhelmed, the new dad is tired, the new mom sore from nursing and may not feel like being touched after putting the newborn down to sleep. Those precious few hours before the next feeding might be needed for sleep or alone time. The amount of sexual intercourse that the couple took the time to have to create their baby, may come to a slow-down if not an all-out stopping point for a while. What’s a couple to do? Discuss. Then schedule sex.

Hilda Hutcherson, MD, a Columbia University assistant professor of obstetrics and gynecology and mother of four, said, it’s critical to just do it. Your physical connection, she says, bolsters your emotional connection: sex releases endorphins, the feel-good hormones, and also oxytocin, the bonding hormone new parents have, promotes feelings of trust and devotion.

Make sex a priority as important as working your 9-to-5 job, getting out for a date night, and keeping up with the bills. Keeping love-making a priority can remind the tired couple why they are together in the first place, and if they can manage to hold on to that “afterglow” feeling for a bit longer each time, the new phase of parenting life may be more enjoyable and less stressful.

Talk it Out
Are you both on the same page? Maybe not, but talking about the feelings and expectations you are both having, now that your family life is different is critical. Maybe your sexual yin and yang are off balance. By being honest about wants and needs, you may be able to get to a new place. Touch each other through non-sexual moments through-out that day to let each other know, “Hey I’m still here” even if you don’t want to have sex in the same way or as often as you once did. And who knows, the more “you” put yourself out there, the honest ideas you are having, could lead to deeper discussions, more fulfilling interactions, all of which strengthen relationships. Once the infant is on a sleep schedule, sex may get back to the way it used to, and if not, keep talking, keep touching, keep an open mind.

Later in Life
Remember those newlyweds? They’ve been married 20 years and have a kid in college. Their sex life should be as important as it ever was, even with the changing bodies as they age with grace. The new normal may be extra foreplay along with lubricants, moisturizers or other enhancements to make the sexual experience more enjoyable for both partners. The pair bonding that the couple enjoyed in the early marriage may still be going, if the couple was able to challenge themselves and each other during the other phases of life so that they can enjoy another “new normal” during this vibrant time of their lives.

If you’re in the New York City area on April 7-9, 2017 join me and colleagues at the The Westin NY at Times Square for our annual Survival Skills for Today’s Gynecologist program. It’s a great time to catch up with friends and hear discussions about the latest in gynecologic patient care. Each day starts with breakfast and includes time for Q&A to deepen the knowledge-share among us.

Along with Steven R. Goldstein, MD who serves with me as Program Co-Director, we have a terrific faculty who will present on leading-edge therapies and topical issues. You might be interested in the most recent recommendations about cervical cancer screening or are wanting more information about HPV education, VVA treatment, hysterectomy procedures, urogynecology, and much more.

On Friday, I will discuss the following topics:

  • Menopausal Hormone Therapy: Primary Prevention of Disease or Not?
  • Office Management of Female Sexual Dysfunction: You CAN do this.
  • Flashes, Flushes, and Night Sweats: New and Non-Hormonal Approaches

My topic for Saturday is Pelvic Floor Biofeedback/Physical Therapy: Should I Offer This in My Office?

The treatment of our patient population is ever-changing, as new treatments and options become available. The business of medicine is changing too. Don’t miss this great CME opportunity, learn some Survival Skills, and thrive in the years to come.

View the entire course or to Register at www.WorldClassCME.com or by phone at (888) 207-9105, M-F 8:30 am – 5 pm EST

Hope to see you there!

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