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Tibolone: An Alternative to Hormone Therapy After Menopause?
La Tibolone: Une Alternative À L'hormonothérapie Après la Ménopause?
Evaluation of health care interventions , the purpose of this work is to investigate postmenopause and certain treatments Symptoms associated with this process of aging in women. Indeed, the initiation of hormone replacement therapy in post-mA (c) nopausA (c) women suffering from climatic (c) ric symptoms has been the subject of (C) following the publication of the results of the Women's Health Initiative (WHI) study. This policy has opened the door to the search for alternatives to hormone replacement therapy. Tibolone, a synthetic (c) synthetic stA (c) rooster with estroga (c) t estrogenic, progestogenic and androgenic properties, would appear to be a promising option. Through this book, an analysis is performed to (A) ) Cision of the Tibolone on the treatment of women post-menopause suffering from climacteric symptoms (heat disturbances, mood disorders, etc.)
If
In June 2006, Organon Pharmaceuticals announced the receipt of a Not Approvable Letter from the U.S. Food and Drug Administration (FDA)
why was a trial going on till 2008 ?
"Tibolone is approved in 90 countries to treat menopausal symptoms and in 45 countries to prevent osteoporosis. Tibolone metabolites have estrogenic, progestogenic, and androgenic activities.1-3Tibolone preserves bone mineral density,4-6 reduces hot flushes,7-9 and may increase libido and vaginal lubrication.10,11 Tibolone treatment has little effect on levels of low-density-lipoprotein cholesterol but decreases levels of high-density-lipoprotein (HDL) cholesterol and triglycerides.5,12Our study, called the Long-Term Intervention on Fractures with Tibolone (LIFT), tested the primary hypothesis that treatment with tibolone reduces the risk of vertebral fracture and, secondarily, modifies the risks of nonvertebral fracture, breast cancer, deep-vein thrombosis, and cardiovascular disease in older women with osteoporosis."
"Tibolone is a synthetic drug that acts like the female hormones estrogen and progesterone in relieving menopausal symptoms. But, unlike estrogen and progesterone, it also reduces the risk of some cancers, the study authors said.
Tibolone: An Alternative to Hormone Therapy After Menopause?
La Tibolone: Une Alternative À L'hormonothérapie Après la Ménopause?
Evaluation of health care interventions , the purpose of this work is to investigate postmenopause and certain treatments Symptoms associated with this process of aging in women. Indeed, the initiation of hormone replacement therapy in post-mA (c) nopausA (c) women suffering from climatic (c) ric symptoms has been the subject of (C) following the publication of the results of the Women's Health Initiative (WHI) study. This policy has opened the door to the search for alternatives to hormone replacement therapy. Tibolone, a synthetic (c) synthetic stA (c) rooster with estroga (c) t estrogenic, progestogenic and androgenic properties, would appear to be a promising option. Through this book, an analysis is performed to (A) ) Cision of the Tibolone on the treatment of women post-menopause suffering from climacteric symptoms (heat disturbances, mood disorders, etc.)
If
In June 2006, Organon Pharmaceuticals announced the receipt of a Not Approvable Letter from the U.S. Food and Drug Administration (FDA)
why was a trial going on till 2008 ?
"Tibolone is approved in 90 countries to treat menopausal symptoms and in 45 countries to prevent osteoporosis. Tibolone metabolites have estrogenic, progestogenic, and androgenic activities.1-3Tibolone preserves bone mineral density,4-6 reduces hot flushes,7-9 and may increase libido and vaginal lubrication.10,11 Tibolone treatment has little effect on levels of low-density-lipoprotein cholesterol but decreases levels of high-density-lipoprotein (HDL) cholesterol and triglycerides.5,12Our study, called the Long-Term Intervention on Fractures with Tibolone (LIFT), tested the primary hypothesis that treatment with tibolone reduces the risk of vertebral fracture and, secondarily, modifies the risks of nonvertebral fracture, breast cancer, deep-vein thrombosis, and cardiovascular disease in older women with osteoporosis."
"Tibolone is a synthetic drug that acts like the female hormones estrogen and progesterone in relieving menopausal symptoms. But, unlike estrogen and progesterone, it also reduces the risk of some cancers, the study authors said.
"Tibolone, which is used around the world for menopausal symptoms, decreases the risk of fractures, decreases the risk of breast cancer, but increases the risk of stroke in this group of women who are all over the age of 60," said lead researcher Dr. Steven R. Cummings, of the California Pacific Medical Center Research Institute in San Francisco.
The drug shouldn't be used in women over the age of 60, particularly those with an increased risk for stroke, Cummings said. "For older women, you should stop taking tibolone or not consider starting it," he said, adding that the drug is not available in the United States.
"Women who are having menopausal symptoms in their 50s can continue to take tibolone, because it is relatively safe and also does have other benefits, such as a reduction in the risk of fracture and breast cancer," he said.
Cummings noted that tibolone is not available in the United States, although it is available in 90 other countries. "It will not be available in the United States, because the company is not asking the U.S. Food and Drug Administration to approve it," he said.
Tibolone is made by Organon, which is owned by Schering-Plough of Kenilworth, N.J. The company has decided not to try to get tibolone approved in the United States because of the increased risk of stroke, Cummings said.
Dr. Michael Strongin, a gynecologist at Lenox Hill Hospital in New York City, said, "All drugs that are being used for menopausal symptoms all have positives and negatives. The task is to find drugs that don't have problems."
"For the U.S. consumer, it's sort of a moot point," Strongin added. "It [tibolone] is not the magic bullet, but I think it's another drug that could potentially be used if it ever does get FDA approval. My caution would be that it's potentially helpful, but it's not a slam dunk that it's better than what we have been using."
The menopause (climacteric) is a physiological process of the female body. The hormone production of the ovaries diminishes, the fertility diminishes, and the absence of menstruation (menopause) gradually occurs. The menstrual cycle begins at the age of 40 and in some women it is only from the beginning to the middle of 50. Due to the shifts in the female hormonal balance, there may be a variety of complaints.
Symptoms include hot flashes, cycle disturbances, sweating, exhaustion, weight gain, edema, blood pressure fluctuations, migraine, palpitations, dyspnea, rheumatoid symptoms, itching, frequent urinary tract infections and bladder weakness, osteoporosis, irritability, anxiety states, depressive mood disorders and sleep disorders.
In this guide, you will receive nutritional advice and recommendations on how to treat and avoid menopause symptoms with the help of phytotherapy, acupressure and hydrotherapy. The most proven medicinal plants, tea recipes, extracts, recipes for tinctures and herbal teas, acupressure points and water treatments are presented. Natural healing is holistic. It not only treats individual symptoms, but also focuses on the entire human being, ie body, soul and spirit. I wish you success, joy of life and, above all, health.
Symptoms include hot flashes, cycle disturbances, sweating, exhaustion, weight gain, edema, blood pressure fluctuations, migraine, palpitations, dyspnea, rheumatoid symptoms, itching, frequent urinary tract infections and bladder weakness, osteoporosis, irritability, anxiety states, depressive mood disorders and sleep disorders.
In this guide, you will receive nutritional advice and recommendations on how to treat and avoid menopause symptoms with the help of phytotherapy, acupressure and hydrotherapy. The most proven medicinal plants, tea recipes, extracts, recipes for tinctures and herbal teas, acupressure points and water treatments are presented. Natural healing is holistic. It not only treats individual symptoms, but also focuses on the entire human being, ie body, soul and spirit. I wish you success, joy of life and, above all, health.
Letter To The Editor
*Reynir T. Geirsson
Department of Obstetrics and Gynecology
Women's Clinic
Landspitalinn University Hospital
Hringbraut
101 Reykjavík
Iceland
e-mail: reynirg@landspitali.is
Department of Obstetrics and Gynecology
Women's Clinic
Landspitalinn University Hospital
Hringbraut
101 Reykjavík
Iceland
e-mail: reynirg@landspitali.is
Sir,
Tibolone (Livial®, Organon, the Netherlands) is a synthetic compound with estrogenic, progestogenic and androgenic properties, a 19-nortestosterone derivative marketed as a perimenopausal hormone replacement drug with an efficacy similar to conjugated estrogens and estradiol valerate (1). It is given on a continuous basis and is not supposed to lead to more than relatively infrequent bleeding (2). Although primarily intended for postmenopausal and older women, 4 years ago this drug was given to a 44-year-old woman who was considered by her gynecologist to be postmenopausal. Postmenopausal status was not ascertained by any blood tests, but a 7-month amenorrhea was considered sufficiently indicative of postmenopausal status. After taking the drug for 4 months the woman realized that she was pregnant, which was confirmed subsequently by an ultrasound scan showing a viable pregnancy at 8 weeks. She discontinued the drug immediately and elected to continue the pregnancy, having a chorion villus sampling (CVS) to confirm a normal karyotype. Detailed ultrasound scanning was normal. The pregnancy continued uneventfully to term, ending about 2 months into the mother's 45th year by delivery of a healthy female baby weighing 3665 g and 52 cm long. The baby was perfectly normal with no signs of clitoral hypertrophy or labial closure or other androgenic effects. She has subsequently developed normally and is now 3 years of age.
Pregnancy occurring while taking tibolone has not been reported, but enquiry with the manufacturer has indicated knowledge of three other cases, two in 44–45-year-old women, one with a shorter exposure (to 4–6 weeks of amenorrhea) and a normal pregnancy outcome, and another with a spontaneous miscarriage after 8 weeks of amenorrhea. In one younger woman the outcome is not known. The drug does not completely suppress ovarian function and thus a pregnancy can occur. It would appear essential to ascertain true postmenopausal status by FSH measurement when giving the drug to younger women. Follow-up of the children may also be a precautionary measure in view of the well-known diethylstilbestrol story and the data on tibolone and breast tumors published recently (3).
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