What is Flibanserin?
Flibanserin is a 5-HT1A agonist/5-HT2 antagonist. It is manufactured by a private German company called Boehringer Ingelheim and was initially produced as an anti-depressant medication. In the late 1990s, the company had developed a molecule called flibanserin that seemed to relieve stress in rats. But unfortunately this medication flopped for this indication. It has a half-life of approximately 7 hours and appears to be safe with minimal interactions with other medications.
Flibanserin shows excellent promise for treatment of hypoactive sexual desire disorder in women. The medication is now in stage 3 clinical trials, and many sexual healthcare providers assume effectiveness with minimal side effect profiles. Most sexual healthcare providers are elated because this medication is not a hormone. It acts centrally and some of the side effects include nausea, dizziness, fatigue, sleeplessness, increased bleeding if on a nonsteroidal anti-inflammatory drug or aspirin. It is perhaps the most promising medication pending for the treatment of female sexual desire disorder. Unfortunately, it is not yet clear exactly how flibanserin works. The company researchers have figured out that it affects several circuits in the brain that may be linked to feelings of enjoyment and pleasure. It may act as a serotonin modulator that restores the balance of this compound. It may restore hormonal balance.
According to the company's spokesperson, one of those brain circuits apparently helps control sexual desire and arousal. The effects of the drugs are not immediate and may take some time to take effect. Recently, data from the Rose study, an open label randomized withdrawal study, were presented in Europe and demonstrated increased desire days and increased satisfying sexual events for women on this medication. Adverse events were minimal, and women who abruptly stopped this medication did not suffer from acute withdrawal syndromes.
Boehringer Ingelheim has placed a large investment in this medication. The company has launched four major clinical trials, involving 5000 women in 220 worldwide locations, with the goal of applying for Food and Drug Administration approval in 2009. Sexual healthcare providers are eagerly awaiting the news of a potential treatment for female hypoactive sexual desire disorder. Flibanserin was recently featured in Business Week magazine and gained publicity and notoriety for the most plausible treatment for hypoactive sexual desire disorder.
There is also a company-sponsored disease registry that will follow many women over the course of 2 years with serial questionnaires. The Southern California Center for Sexual Health and Survivorship Medicine was chosen as a premier vanguard site. Eligible participants may enroll after the informed consent procedure and are entitled to remuneration.
What is tibolone?
Tibolone (Livial) is a synthetic hormone-type drug. It is used mainly for hormone replacement therapy in post-menopausal women. Tibolone can help relieve symptoms of the menopause transition including hot flashes, night sweats, mood changes, and vaginal dryness and vaginal irritation. It can also help to prevent bone health issues such as osteoporosis (a loss of bone mass so that bones become brittle and easily broken).
Generic tibolone tablets are not yet available. Many studies over the last 5 years show that tibolone, a new female hormone, shares many effects with male hormones and may help to prevent bone problems and lack of sexual desire. It does not increase breast cancer risk and does not have to be taken with progesterone to prevent uterine cancer. Tibolone's cardiovascular effects are much more murky. On the positive side, the drug reduces total cholesterol and harmful triglycerides and slightly lowers low-density lipoproteins (LDLs, or bad cholesterol). But it also lowers high-density lipoproteins (HDL, or good cholesterol). Many experts are concerned about this mixed picture, and it may affect cardiovascular health.
Livial is available in much of continental Europe and in the United Kingdom, but is not yet available in the United States. Basically, this molecule combines some of the positive effects of estrogen, progesterone, and testosterone. It has been shown to reduce hot flashes, increase bone mineral density, and women report that it decreases vaginal dryness. The drug does improve desire, but researchers are uncertain of its effect on other parameters of female sexual function. There are some medical concerns regarding the lipid metabolism, hemostasis, and long-term cardiovascular and cancer risks.