Archive for the ‘hot flashes’ Tag

Hormone Therapy Combination Granted FDA Approval for Treating Menopausal Women   Leave a comment

It has been just over 5 years since Alice died – I’ve kept this blog and her message boards basically the way she started them.  I decided  – finally – that life goes on and new discoveries are being made to help women going through menopause.

To that end, I decided to include news items of relevance here and here’s the first…

Officials with the FDA have approved TherapeuticsMD’s Bijuva (estradiol and progesterone) capsules, 1 mg/100 mg, the company announced Monday. According to TherapeuticsMD, Bijuva is the first and only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate to severe vasomotor symptoms due to menopause in women with a uterus.

“The approval of Bijuva represents an important and new opportunity for menopausal women suffering from moderate to severe vasomotor symptoms. Menopausal women and their healthcare providers have been seeking bio-identical combination therapies for many years without an FDA-approved option,” said Dr. Brian Bernick, Co-Founder and Director of TherapeuticsMD, in a prepared statement. “Bijuva is the first and only FDA-approved combination of bio-identical hormones, offering a proven balance of bio-identical estradiol to reduce moderate to severe hot flashes combined with bio-identical progesterone to reduce the risks to the endometrium.”

The approval is based on the Bijuva clinical development program that included the pivotal Phase III Replenish Trial. This trial evaluated the safety and efficacy of Bijuva in generally healthy, postmenopausal women with a uterus for the treatment of moderate to severe hot flashes. Consistent with FDA guidance, the co-primary efficacy endpoints in the Replenish Trial were the change from baseline in the number and severity of hot flashes at weeks 4 and 12, as compared to placebo. The primary safety endpoint was the incidence of endometrial hyperplasia with up to 12 months of treatment.

Bijuva demonstrated a statistically significant reduction from baseline in both the frequency and severity of hot flashes compared to placebo while reducing the risks to the endometrium. The most common adverse reactions (≥3 percent) were breast tenderness, headache, vaginal bleeding, vaginal discharge, and pelvic pain. Additionally, there were no clinically significant changes in lipid, coagulation or glucose parameters as compared to placebo. There were no unexpected safety signals.

“For the first time, we have a combination hormone therapy of bio-identical estradiol with bioidentical progesterone evaluated in a large, well-controlled, randomized clinical trial that has demonstrated both safety and efficacy for the treatment of moderate to severe hot flashes due to menopause,” said Dr. James Liu, M.D., President of the North American Menopause Society and Chairman of the Department of Obstetrics and Gynecology, UH Cleveland Medical Center, in a prepared statement. “The approval of Bijuva represents an important, novel and effective treatment option for women and their healthcare providers to manage the vasomotor symptoms of menopause.”

Bijuva is expected to be available in the United States in 2019.


TherapeuticsMD Announces FDA Approval of TX-001HR: BIJUVA (Estradiol and Progesterone) Capsules for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause [news release]. Boca Raton, FL; October 29, 2018: TherapeuticsMD.


Menopause sometimes requires a survival guide   Leave a comment

Menopause has gotten a bad rap. Women in their 40s and 50s who have any symptoms – from moodiness to insomnia and headaches – may believe that it’s a normal part of aging and there’s not much they can do about it.

Fluctuating hormones caused by the normal decline of ovarian function can trigger the typical symptoms associated with menopause. One approach is to give the body a drug that mimics ovarian function, such as estrogen or hormone replacement therapy. This was a common treatment, until multiple studies showed increased risk of urinary incontinence, stroke, dementia and breast cancer from using menopausal hormone therapy.

Fortunately, there is another approach to improving the body’s ability to adjust to hormone fluctuations that doesn’t increase the risk of breast cancer and dementia. This approach looks at the other organ systems that are involved in addition to the ovaries. For instance, hot flashes will be greatly exaggerated in a woman who has blood-sugar problems – even if those don’t show up on a standard blood test.


Some women use bioidentical hormones instead. While they appear to have fewer immediate side effects, there is no evidence that they have fewer long-term risks.

At a recent functional medicine conference I attended, there were several discussions on how to address hormone “saturation” – the experience many women have after being on bioidentical hormones for several years and then having a return of their previous symptoms. We’re learning that underlying imbalances in gut function, adrenal hormones and blood sugar can have a major effect on a woman’s experience of her perimenopausal years.


Technically, menopause occurs when a woman hasn’t had a period for 12 consecutive months. The symptoms that can occur for years before that are due to the ovaries becoming less predictable in their hormone production. This means that estrogen levels can spike and fall like a roller coaster.

Unfortunately, once a woman knows that her hormones are fluctuating, she is likely to explain away all her symptoms as perimenopausal. But ovaries are not the only glands affected by hormone changes. The pancreas, thyroid and adrenal glands play key roles in determining how easy or difficult the perimenopausal years will be.

The most common, end-stage effect of pancreas dysfunction is diabetes. But long before the body reaches a disease state, there are more subtle effects. For instance, a woman with low blood sugar or insulin resistance will experience more severe hot flashes than a woman with normal blood-sugar regulation.

Following are common symptoms associated with perimenopause and factors that can determine the severity of those symptoms.

• Heavy or frequent periods. These can be worsened by blood-sugar and thyroid imbalances that don’t show up on routine blood work. Checking free and total levels of T3 and T4 as well as thyroid antibodies can be helpful.

• Hot flashes or low libido. Underlying adrenal stress can result in cortisol levels that are too high or too low, or reduced DHEA (precursor to several hormones). Cortisol levels are best tested with multiple saliva samples over a 24-hour period.

• Insomnia. With or without hot flashes, insomnia is often due to chronic stress, which causes the adrenals to produce excess cortisol.

• Mood changes and brain fog. Moods can be affected by the stress hormone cortisol as well as imbalanced neurotransmitters. Neurotransmitters such as serotonin are made primarily in the gut and can be evaluated with a urine test. Low levels of serotonin can also increase overall pain levels.

• Hair loss and weight gain. There may be underlying thyroid stress that doesn’t show up on routine blood work but requires a more detailed look at free and total levels of T3 and T4 and thyroid antibodies.

Once these underlying issues are identified, they can be addressed through food choices, lifestyle factors and specific supplements.

Marina Rose, D.C., is a functional medicine practitioner, certified clinical nutritionist and chiropractor with an office at 4546 El Camino Real in Los Altos. For more information,  visit


The Science Behind What Happens In a Woman’s Body During …   1 comment


Despite the bold and assertive name by which the hot flash is known, her origins remain elusive. Of course, doctors and scientists understand many of the mechanisms of menopause such as the reduction in estrogen and the important relationship between the ovaries and the pituitary gland, but the central cause of hot flashes – the heating of a woman’s core – is a secret Mother Menopause has yet to reveal.

“I’ve written editorials that we’ve sent men to the moon and we’ve broken the genetic code, but we cannot really explain the physiology of a hot flash,” said Cynthia Stuenkel, M.D., clinical professor of medicine, endocrinology and metabolism at the University of California, San Diego, School of Medicine in La Jolla, Cal.


What is known then? The hot flash seems to be an equal-opportunity phenomenon, plaguing as many as 75 percent of women, regardless of race or reproductive history. Whether you had children, and how many, and at what age, or remained childless, doesn’t seem to have any correlation with hot flashes, their severity or frequency. Nor does breastfeeding history or the age at which a woman began or stopped menstruating.

Smoking is believed to bring on menopause about one to two years early and some inherited tendencies can mean that women in the same family may see their eggs becoming less responsive around the same time of life. Obesity is believed to cause more hot flashes in some medical circles. But other doctors disagree.

What they do agree upon is that the thermoregulatory center of the brain which regulates temperature somehow loses its typical functioning capacity as estrogen decreases. Follicle-stimulating hormone (FSH) is produced by the pituitary gland in the brain. Its job is to stimulate the dominant follicle on one of a woman’s ovaries each month to release an egg.

But as the number of eggs decline throughout a woman’s childbearing years, the ovaries makes less estrogen and communicate this situation to the pituitary by “talking back” to it with a hormone called inhibin. The pituitary responds to the decline in estrogen by sending out more FSH, a hormone that is often measured when trying to gauge a woman’s fertility.

What isn’t more intimately understood is how the declining estrogen levels affect thermoregulation in the brain and specifically a center called the hypothalamus. Internal and external symptoms do not mirror the subtleties going on in the brain.

During a typical hot flash, which lasts from two to five minutes, a woman experiences a feeling of heat, usually in the upper torso, as blood vessels dilate. “In some women that are fair you’ll see some redness,” said James Liu, M.D., chair of the department of obstetrics and gynecology at University Hospitals/MacDonald Women’s Hospital at Case Western Reserve University School of Medicine in Cleveland, Oh.

Liu said the internal core temperature actually drops a little despite the feeling of heat, while fingertip temperature goes up. Epinephrine, also known as adrenaline, courses through the bloodstream, sometimes causing an increased heart rate.

That can be disconcerting to women who have been taught of late not to ignore what can be the more subtle symptoms of heart attack in women. Liu offers simple advice for determining the difference between a hot-flash-induced pounding heart and a heart attack. “A heart attack is unrelenting,” he explains. “A heart attack episode is constant.”

The pounding heart that comes with the hot flash ends with the heat. Unfortunately, that drop in core temperature often sends women on a rollercoaster ride in the other direction, now feeling cold, and, of course, often very wet from copious sweating.

“We don’t know what triggers the temperature instability. That’s something we’re trying to figure out,” Liu said, echoing Stuenkel, and explaining that normally humans maintain a very stable temperature even under warm conditions.


Cynthia Stuenkel, M.D. via phone interview July 3, 2015 James Liu, M.D., via phone interview July 6, 2015

via The Science Behind What Happens In a Woman’s Body During ….

Posted August 7, 2015 by MaryO in From Elsewhere

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