CarolAnn Tutera will be the guest host for two hours on 11/24 on 99.9KEZ The Holiday Station helping to bring in this season with health and holiday spirit!!
Listen in and enjoy the beautiful music and CarolAnn talk about hormonal balance.
Questions about hormone therapy come up frequently in the Menopause Chicks Private Online Community.
It’s common for women who might be experiencing things like brain fog, low libido, vaginal dryness, headaches, anxiety, depression, hot flashes/night sweats and even dry skin or hair loss—to investigate hormone therapy and the different modes of delivery available.
Recently, we have heard about pellet therapy from a number of women in our community—some who have regained quality of life as a result of pellet therapy, some who heard about pellet therapy from their physicians, and others who are curious and beginning to be proactive with their midlife health. So, we sat down with the owner of SottoPelle Therapy so we can all learn more.
Tune into my conversation with CarolAnn Tutera—and be sure to stay on to the 18 minute mark, as CarolAnn talks about hormone changes in men too!
What is pellet therapy?
Pellet therapy is an innovative way of delivering hormone therapy. By inserting pellets (about the size of a grain of rice) under the skin, this precision delivery method transports a customized dose of hormones through the blood stream, around the clock.
Why might a woman choose pellet therapy?
- Pellet therapy has been around for more than 70 years
- It’s a viable way for women to avoid the hormone roller coaster
- Delivering hormone therapy via pellets ensures that the prescribed dose is absorbed into a woman’s blood stream; the most reliable delivery method available as pills, patches and creams can be deemed inconvenient and inconsistent. With pellet therapy, there’s nothing to remember. Each treatment is tailored to suit the individual needs of the woman rather than a one-size-fits all or guesswork approach. It contains low-does estradiol and testosterone that release slowly for three to six months and includes regular monitoring and adjustments when your body needs it.
- Because the treatment is customized to each individual, doctors who administer pellet therapy are not merely treating symptoms but they treat the whole person. In addition, women will often choose pellet therapy because they are interested in quality of life NOW, and keen to invest in their longevity and vitality down the road—by protecting their cognitive health, preventing osteoporosis—as well as simply replenishing what their bodies need.
What options are available for men?
Men are frequently pleased when their partners/wives choose pellet therapy as they recognize how effectively it restores her quality of life. But men are also advocates of pellet therapy for their own health too—for similar reasons as women. You see, as a rule, men don’t experience the drastic roller coaster of hormone fluctuation that women do (although some do!), they do have experiences in midlife such as fatigue, brain fog, low libido and anxiety and depression that can be addressed with personalized hormone therapy.
Where can I learn more?
CarolAnn Tutera is the owner of SottoPelle Therapy
The first step is a consultation. SottoPelle Therapy is available throughout the USA.
Find a doctor in your area by visiting SottoPelleTherapy.com
Get Involved with educating and eradicating misconceptions about aging.
SottoPelle Therapy has and is dedicated to helping people find balance in their life. Hormonal balance is a critical and foundational component of healthy aging but there are many other aspects for aging gracefully. Our newest website – SottoPelle Lifestyle supports our mission to educate, entertain, and eradicate misconceptions about aging while highlighting various influencers that support the values of authentic aging and a healthy lifestyle. We hope you find the site interesting with informative programs that support the improvement of health and well being of aging adults. On the site, you will see some of our influencers with advice on fitness, nutrition, care-giving, style and more. Our own authentic aging ambassador and influencer CarolAnn Tutera will be hosting a podcast to discuss important topics to nurture a balanced and healthy lifestyle. One such example of an interesting program is the NYU Aging Incubator.
“The percentage of the world population aged 65 or over is expected to double by 2050. This presents enormous challenges to: health care, the labor force, and the financial health of key institutions, amongst others. The NYU Aging Incubator was established in 2016-17 as a university-wide initiative bringing together faculty and students from across the University from all disciplines who are involved in the study of aging and its impacts. It is hoped that the NYU Aging Incubator will be the resource for the NYU community to find information on research, educational activities, events, and services for the aging community and provide support for the development of innovative and interdisciplinary research, policy and educational endeavors, to improve the health and well-being of older adults.
If your interested in supporting authentic aging or want to become a contributor to SottoPelle Lifestyle please contact us today at AgingMatters@sottopellelifestyle.com
Many women find perimenopause and menopause symptoms take them by surprise. Some don’t go to the doctor until they are in the throes of fatigue, mood swings, low sex drive and hot flashes to name a few. They are remiss to seek treatment because they’ve heard that solutions such as hormone replacement therapy may be hazardous to their health. So they white-knuckle it in silence. We had the opportunity of interviewing an expert, Dr. Gino Tutera, who spent many years investigating ways to help women during menopause feel normal during this tough time in life. Dr. Tutera found hormone replacement methods were the best way to help women during their menopausal years before creating his unique pellet therapy approach. He is SottoPelle® Founder and Medical Director of SottoPelle Hormone Replacement Therapy. Following are his answers to the questions we asked him, to inform our readers. He explained that all hormone replacement therapies are not the same.
Viva Fifty.- How and when should women consult a doctor about their peri-menopausal or menopausal symptoms?
Dr. Gino Tutera.- Women should not wait until symptoms strike before checking their hormone levels. As we age, our hormone levels decline. Recent studies show that women are experiencing peri-menopause and menopause at much earlier ages than expected. By age 40, most women are totally depleted of normal levels of estrogen and have lost nearly all their progesterone and more than half of their testosterone. These fluctuating levels can lead to more serious health issues since many diseases are correlated with hormonal imbalances. Estrogen impacts cognitive function and testosterone affects the heart, breast and bones. In order to protect their health, women need to check their hormonal balance regularly starting at age 40.
Viva Fifty.- What are bio-identical hormones in layperson language and how can women benefit from them?
Dr. Tutera.- Bio-identical hormones (BHRT) are natural, plant-derived compounds that have the same molecular structure as those made by the human body – as opposed to other traditional forms of hormone therapy (HRT), which are synthetic, or pharmaceutical. The molecular structure of bio-identical hormones is identical to the hormones produced naturally by the human body, hence the name. Therefore they are better assimilated without the dangerous side effects associated with synthetic hormones.
Viva Fifty.- How many years can women take these hormones and how costly are they?Dr. Tutera.- Hormonal imbalances can strike a woman at any age and are not reserved just for older women in menopause. The need for hormones all depends each individual woman’s levels and a simple blood test is used to measure that. Since bio-identical hormones are natural without the harmful side effects of pharmaceutical hormones, there is no limit to the time frame in which a woman can take them if she needs them. Since our food, water and environment are loaded with toxic chemicals, this disrupts the body’s delicate endocrine system which leads to hormonal balance. Women can protect their health by maintaining proper hormonal balance at any age.
The cost for bio-identical hormone therapy is around $300 with the pellet method and lasts an average of 3-4 months. So the monthly cost is $75. The blood test costs vary depending on what lab is used but generally run less than $100 and is usually covered by most health insurance.
Viva Fifty.- Beyond HRT or BHRT, what else can women do to improve their self-image and self-esteem during perimenopause, menopause and beyond?
Dr. Tutera.- Women can learn to love themselves at any age. The best way for women to improve their self-image and self-esteem is to start with inner health and happiness … the beauty that radiates from the inside out.
Body type and self-image for women are undergoing a rapid shift with the dramatic rise in America’s aging population. Today there are 78 million Americans over age 55 and over half of them are women. And one in every three people is over 50. This means vast numbers of women are facing aging issues and experiencing menopause. So the demand for more reasonable body images and role models is changing to serve the needs of this aging female demographic. There has been a louder voice for acceptance for those who do not meet the weight and image standards we see on TV, magazines, social media and basically everywhere.
Dr. Ivanka Prichard, a behavioral psychologist, is one advocate leading a research team to determine if the new “fit-spirational” trends do women’s body image and psychological health more harm than good. “Healthy is the new skinny!” she declares.
Viva Fifty.- What about women´s fear of cancer due to HRT?
Dr. Tutera.- It’s a misguided perception based on synthetic HRT, not natural BHRT. Some misunderstanding persists around hormones because many people and even doctors don’t realize that there are two different kinds – synthetic and bio-identical.
When the Women’s Health Initiative released a report in 2002 citing the dangerous side effects of synthetic hormones, it gave all hormones a bad reputation. To this day most news reports fail to make this critical distinction between the two different types of hormones and thus all forms of hormones are falsely considered dangerous. BHRT began in Europe in the 1930’s and is backed by over 75 years of research.
Extensive research shows that cancer is associated with synthetic or pharmaceutical HRT. Numerous studies point to the health benefits of BHRT in helping to protect women against breast cancer. Here are four as an example:
Tutera, D. Gambrell, Marked reduction of breast, endometrial and ovarian cancer in users of bio-identical estradiol and testosterone subcutaneous pellets, Maturitas, 2013: “Subcutaneous estradiol and testosterone pellets do not increase the risk of development of any of these cancers and, in fact, may be protective.”
Natrajan and Gabrell, American Journal of OB-GYN, 2002: “Bio-identical estrogen does not increase either recurrence of breast cancer or mortality rates.”
Roger Smith and John Studd, British Journal of Hospital Medicine,1993: “Hormone pellet therapy does not increase the risk of breast cancer incidence.”
Davelarr Study, 1991: “No increase in the incidence of breast cancer during the use of subcutaneous estradiol in women from 1972-mid-1990s… less cancers overall than the control group on no estrogen therapy.”
Viva Fifty.- What is the key to effective hormone therapy?
Dr. Tutera.- Sex hormones play a much larger role in our health beyond a reproductive purpose. They are the “control panel” of the human body and impact all organs, tissues and neurotransmitters. In fact, they affect every aspect of our physical and mental well-being and can also help prevent illness, disease and premature aging.
The key to effective hormone therapy lies in the delivery method. Pills, patches, creams, gels, troches and other methods often result in roller coaster surges of hormones. Studies demonstrate that hormone pellets, which are about the size of a grain of rice and slipped under the skin, provide the most effective delivery system because they are monitored naturally by the body’s own heart rate for 24-7 distribution exactly when the body needs it most.
Most synthetic hormones and even some bio-identical hormone pellets offer one-size-fits-all generic doses that are not designed to meet each woman’s unique hormone needs. Every woman doesn’t wear the same size shoe; so why would they all choose the same hormone dose? SottoPelle® Therapy is the only method that uses a proprietary web-based BioCalc® system with precision dosing for each patient’s specific requirements and carefully monitored to manage her hormone balance properly.
Hormone therapy is not just about menopause or for women only! Men lose most of their testosterone by age 50 and need hormonal balance when andropause sets in. Like women, they should have their levels checked before symptoms arrive to protect their health.
SOURCE: Viveve Medical, Inc.
Viveve Medical, Inc.
March 19, 2018 08:28 ET
Viveve Announces FDA Approval of IDE to Conduct VIVEVE II Clinical Study
Trial expected to begin in second quarter 2018
Future results could support a marketing application for an expanded U.S. indication for the improvement of sexual function in women
ENGLEWOOD, CO–(Marketwired – March 19, 2018) – Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on women’s intimate health, today announced it received approval of its Investigational Device Exemption (IDE) application from the U.S. Food and Drug Administration (FDA). The approval allows the company to conduct the VIveve Treatment of the Vaginal Introitus to EValuate Safety and Efficacy (VIVEVE II) clinical trial to assess the safety and effectiveness of the Viveve® System for the improvement of sexual function in women following vaginal childbirth.
“The approval of our IDE enabling Viveve to proceed with the VIVEVE II clinical study is a major advancement in our global commercialization strategy and positions our CMRF (cryogen-cooled, monopolar radiofrequency) technology for a broader range of applications in women’s intimate health. The initiation of this study, which is expected to occur in the second quarter of 2018, underscores our continued commitment to conducting high-quality, scientific and clinical research, as demonstrated by our previous randomized, blinded and sham-controlled VIVEVE I clinical study, and by our planned randomized, blinded and sham-controlled LIBERATE studies in the U.S. and Canada for the treatment of stress urinary incontinence,” said Patricia Scheller, chief executive officer and director of Viveve. “We believe that VIVEVE II, if successful, will clinically demonstrate that a single treatment with the Viveve® System provides significant benefits to women suffering from diminished sexual function following vaginal childbirth and may support a marketing application for an expanded U.S. indication for the improvement of sexual function.”
VIVEVE II – VIveve Treatment of the Vaginal Introitus to EValuate Safety and Efficacy
The VIVEVE II clinical study is a randomized, double-blinded, and sham-controlled trial with a planned enrollment of approximately 250 patients at up to 25 study sites in the United States and Canada. Subjects will be randomized in a 1:1 ratio for active and sham treatments.
A staged approach, or roll-in, for clinical enrollment has been required by the FDA in its IDE approval letter to the company. In the first stage, enrollment is limited to 50 subjects. The roll-in will require safety review by the FDA of a minimum of 25 subjects, one-month post-treatment. Following the roll-in, an IDE Supplement will be submitted to the agency to expand the study up to its intended 250 patients. While the safety data from the initial 25 patients are being reviewed by the FDA, Viveve will continue to enroll up to an additional 25 patients (total of 50 patients enrolled).
The primary efficacy endpoint is intended to be the mean change from baseline in the total FSFI (Female Sexual Function Index) at 12 months, following the submission of an IDE supplement. Patients will also be assessed for safety over the 12 months. The approved protocol also includes a variety of secondary and exploratory endpoints, including various endpoints measured at 6 months post-treatment. Initiation of the VIVEVE II study is anticipated to begin in the second quarter of 2018, pending Institutional Review Board approvals at the selected clinical sites.
Additional information regarding the trial design will be available on clinicaltrials.gov.
Ms. Scheller continued, “Viveve has worked closely with the FDA in the review process and appreciates the thorough review that the Agency has conducted. If the planned VIVEVE II study is successful, we believe it will show that Viveve’s CMRF technology can provide a safe and effective, single treatment option to improve sexual function after childbirth.”
Viveve Medical, Inc. is a women’s intimate health company passionately committed to advancing new solutions to improve women’s overall well-being and quality of life. The internationally patented Viveve® System, that delivers the GENEVEVE™ treatment, incorporates clinically-proven cryogen-cooled, monopolar radiofrequency (CMRF) technology to uniformly deliver volumetric heating while gently cooling surface tissue to generate robust neocollagenesis in a single, in-office session.
International regulatory approvals and clearances have been received for vaginal laxity and/or improvement in sexual function indications from over 55 countries. Viveve received approval of an Investigational Device Exemption (IDE) application from the U.S. Food and Drug Administration (FDA) in March of 2018 to proceed with VIVEVE II, a multicenter, randomized, double-blind, sham-controlled study to assess improvement of sexual function in women following childbirth. Initiation of the trial is expected to begin in the second quarter of 2018 and if successful, could support a marketing application for a new US commercial indication. Currently, in the United States, the Viveve® System is cleared by the FDA for use in general surgical procedures for electrocoagulation and hemostasis.
InControl Products by Viveve are FDA-cleared medical devices that treat stress, urge, and mixed incontinence conditions and that improve pelvic floor strength. Viveve exclusively distributes InControl Medical’s products to healthcare providers in the United States.
For more information visit Viveve’s website at www.viveve.com.
Safe Harbor Statement
All statements in this press release that are not based on historical fact are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. While management has based any forward-looking statements included in this press release on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties and other factors, many of which are outside of our control, which could cause actual results to materially differ from such statements. Such risks, uncertainties and other factors include, but are not limited to, the fluctuation of global economic conditions, the performance of management and our employees, our ability to obtain financing, competition, general economic conditions and other factors that are detailed in our periodic and current reports available for review at www.sec.gov. Furthermore, we operate in a highly competitive and rapidly changing environment where new and unanticipated risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.
Viveve is a registered trademark of Viveve, Inc.
Geneveve is a trademark of Viveve, Inc.