Menopause

Another uniquely female health concern is menopause. Women are capable of conceiving children because of both the reproductive organs in their lower abdomen and the hormones the ovaries and adrenals produce. Estrogen and progesterone cycle, causing the release of an egg, its maturation, and if sperm is present and infiltrates the egg - implantation of the zygote to mature as an embryo, fetus, and child. When the egg is not fertilized, the hormones cause the uterine lining to be refreshed in case there is a zygote to nourish during the next cycle. This menstrual cycle repeats itself monthly (approximately 28 days, but this varies by woman and her natural hormonal rhythm, which changes with age as well) from puberty to middle age.

Like the rest of the body, the ovaries age and the decreased estrogen in the body results in a cessation of the menstrual cycle around the age of 50 (earlier or later, varies by woman), known as menopause. This hormonal change also causes symptoms - hot flashes being the most stereotypical, though many women don't have symptoms. Hormonal replacement therapy (estrogen pills) were used as a way to treat these symptoms, but it was found to have unplanned cardiovascular risks. Similar to hormonal birth control, synthetic and combination therapies were tested to reduce the side effects while keeping options open for women. Prempro is one such treatment. However, anyone opting to take Prempro should discuss the potential adverse effects with their doctor

Prempro is a combination hormonal therapy used to treat symptoms of menopause, such as hot flashes. The pill contains conjugate estrogens and medroxyprogesterone acetate. Estrogen used alone was found to increase the risks of uterine cancer, dementia, strokes, and blood clots. Progestins (like progesterone) were added to reduce these risks, but the combination treatment has its own adverse effects, such as an increased risk of breast cancer.

The Women's Health Initiative was a 15-year program that investigated the most common causes of death and disease in postmenopausal women. The study included an evaluation of hormone therapy in 60,000 women. The estrogen plus progestin substudy was halted early, after a little more than 5 years, due to the risks outweighing the benefits. Women treated with the combination therapy in the study had increased risk of heart attack, stroke, venous thrombosis, and blood clots.

Breast and lung cancer risks are also increased by Prempro use. As reported in USA Today in October 2010, a study comparing Prempro use to placebo found an increased risk of breast cancer, and an increased risk of that cancer’s spread to the lymph nodes (metastasis). Women taking the drug were also more likely to die from breast cancer. A previous study that year had found an increased risk of death from lung cancer, though it did not increase the risk of lung cancer per se.

A positive side effect though is a decreased colorectal cancer risk in those who are treated. In addition, stopping treatment results in normal breast cancer risk within 2 years of stopping.

The FDA also warns of potential increased risk of dementia with Prempro use in women aged 65 years and older. The exact combination in the Prempro pill was not studied in the Women’s Health Initiative substudies (cardiovascular and dementia risks), but the FDA assumes, in the absence of that specific data, that the estrogen plus progestin study findings are applicable to estrogen plus medroxyprogesterone.

In addition, Pfizer's label includes the following side effects: high blood pressure, liver problems, depression, increased benign fibroid size in the uterus, high blood sugar, benign breast lumps and breast discomfort, unusual vaginal bleeding and spotting, fatigue and dizziness, severe headaches, chest pain, changes in vision and speech, leg pain, shortness of breath, fluid retention and bloating, vaginal dryness and yeast infection, hair loss, stomach pain, and headaches, sometimes severe.

The discomfort of menopause will subside on its own once the hormones become regulated, usually over the course of a year or two, though the symptoms may recur for up to 5 years. Women with severe symptoms may find relief in treatment, though they may have their own side effects to consider.

Woman's choice - Hormonal contraception

Source: Ceridwen, Wikimedia Commons

Women have the unique characteristic among the two sexes of the human species as the one capable of giving birth. Pregnancy has many emotional topics that surround it, including that of prevention. Contraception has been a topic of study for thousands of years, with spermicidal plants being a focal point of ancient Egyptian medicine. This same culture is credited as using the first condoms roughly 3000 years ago.

In the 20th century, contraception reached the woman's control again with the advent of hormonal contraception - the birth control pill. Rather than relying on the spermicidal effects of chemicals, the pill alters the levels of hormones in a woman's body, redirecting, or sometimes altogether preventing, ovulation. Basically restricting the body's ability to conceive.

In the last half century, synthetic hormones and combinations have been tested and marketed in order to fine tune the process, achieving as high as 99% reliability when used properly, as well as eliminate side effects, which can include cardiovascular problems and female cancers.

Each woman can decide just how she wants to control her ability to conceive - see WebMD for a list of available types, along with their pros and cons.

Birth control firsts: Natazia

Birth control pills. Source: Ceridwen, Wikimedia Commons

On May 6, 2010, the FDA announced that it had approved Bayer’s Natazia (approved in Europe as Qlaira since May 2009) for use in women to prevent pregnancy with the exception that it should not be prescribed to women over 35 who smoke due to cardiovascular risks, and the company points out that its effectiveness has not been tested in obese (BMI >30) individuals. In two clinical trials that included more than 1800 women, the pill was deemed to be as effective as other oral contraceptives on the market.

This manifestation of the pill contains a synthetic estrogen called estradiol valerate and a progestin called dienogest - the first time this specific combination has been used. However, combining estrogen and progestin has been shown reduce the adverse hormonal effects of estrogen in regards to cancer risks and has become standard practice for long-term hormonal therapy, such as oral contraception. Most other birth control pills use the estrogen known as ethinyl estradiol.

 

The pill was approved to prevent pregnancy but was also shown to reduce bleeding in women with excessively heavy periods. However, obese women may not benefit from this drug. The lack of evidence in women with a BMI >30 is important because fat tissue produces estrogen, which can be counterproductive to the pill dose, as well as the fact that larger individuals absorb medication differently, which may alter the actual dose received in some individuals.

Natazia is expected to be available for prescription in summer 2010. According to Bayer, The pill should not be used by women with liver disease, who are pregnant, who have a high risk of thrombotic diseases, or who have undiagnosed hormone-sensitive reproductive cancers (which actually can’t be known until it is too late, so it is odd that the company mentions this except to stave off eventual lawsuits). Women should avoid smoking cigarettes while on the pill to prevent an increased risk of cardiovascular complications, especially women over 35 years of age. All birth control pills increase the risk of clotting and cardiovascular events to some extent, and Natazia is no different. The risk is highest during the first year of use.

However, some questions about the safety of the new birth control pill are being asked. Some feel that Bayer did not conduct appropriate safety testing, only efficacy for their marketing angle. And while the company is embroiled in lawsuits and recalls over Natazia’s predecessor, Yaz and Yasmin, some people wonder if they should not have been more diligent to assure both the FDA and the public that they can produce a safe contraceptive. (For more information on this see Jim Edwards’ May 7, 2010 article at bnet, “More questions than answers about safety of Natazia, Bayer’s new contraceptive”).

Because each individual reacts differently to hormones, having many options on the market broadens the access women have to hormonal birth control.

Before getting into the differences in the various types of oral contraceptives, it is important to understand how they work in general. Oral contraceptives contain hormones. The first pill in 1960 had high doses of hormones (estrogen and progestin), but this resulted in clotting and other dangerous side effects. Over the decades the hormone dose has been lowered and today’s combination oral contraceptives have the lowest effective doses. The hormones have been fine-tuned as more about the natural hormone rhythms in the human body have come to light and as synthetic estrogens have been produced. Fertility and pregnancy are hormonal conditions – by manipulating a woman’s hormone levels, ovulation and the steps leading to pregnancy can be controlled to the extent that pregnancy is prevented. Oral contraceptives are 92-99.7% effective at preventing pregnancy if used as directed for the particular pill.

One difference with Natazia is that it was shown in the clinical trials prior to approval to decrease menstrual bleeding. They found that for women with excessive or heavy menstrual bleeding, periods were lighter, and that 16% of women had amenorrhea (no period).

 

Another difference between Natazia and other birth control pills are the hormones they contain. Most birth control pills contain the estrogen ethinyl estradiol. Natazia is the first to contain the synthetic estrogen known as estradiol valerate, which is converted to estradiol within the body. In combination with this, Natazia contains the progestin dienogest, which other pills also contain, but this is the first approved four phase contraceptive. Usually birth control pills with ethinylestradiol/dienogest are monophasic – the woman receives one dose throughout the cycle, which prevents ovulation. The estradiolvalerate/dienogest combination in Natazia delivers four different doses through the 28-day cycle, offering a finer tuned control of the hormone levels. 

 

The specific four phase doses used in Natazia are 3 mg estradiol valerate for 2 days, 2 mg estradiol valerate and 2 mg dienogest for 5 days, 2 mg estradiol valerate and 3 mg dienogest for 17 days, and 1 mg estradiol valerate for 2 days, followed by two inert tablets like in other monthly contraceptives. The dienogest (progestin) dose is what is thought to prevent ovulation.

Common side effects of the pill in clinical studies included weight gain, acne, breast pain and discomfort, irregular menstruation, nausea/vomiting, and headache. The pill should not be used by women who are pregnant, have a high risk of thrombotic diseases, have undiagnosed hormone-sensitive reproductive cancers, or have liver disease. Associated cardiovascular and clotting risks are highest during the first year of use. In addition to the cardiovascular risks, the use of Natazia is associated with increased risks of gallbladder disease, hypertension, liver cancer, and ruptured cysts.

Despite these differences, Natazia was shown to be as effective as other birth control pills, and the side effects and complications for Natazia are not expected to be any different from the pills currently on the market. Women, especially those over the age of 35, should avoid smoking cigarettes while on the pill to prevent an increased risk of cardiovascular complications.

Insulin resistance and hormones

Insulin resistance is a condition in which the body’s insulin receptors are not as receptive to the hormone insulin, causing the pancreas to produce more insulin in order for the body to appropriately convert blood glucose to energy. Though some of the factors involved are known, the exact causes of insulin resistance are not known. As such, the effect of insulin resistance on other body processes versus simultaneous pathological processes is not entirely clear. However, some conditions are associated with insulin resistance and share hormone signals, including sex hormones, inflammatory cytokines, and growth hormones. Read more about hormones affected by insulin resistance.