Paula Hillard, a gynecologist at the Stanford University School of Medicine is not convinced of the clinical meaningful benefit of Flibanserin. We, on the other hand, are quite assured of the positive benefits of Flibanserin, and believe that the FDA will eventually reconsider their decision. We believe Flibanserin will have the biggest impact on pre-menopausal women with Hypoactive Sexual Desire Disorder.

Flibanserin was elaborated by the German Company Boehringer Ingelheim and was promoted as a product capable of providing “satisfying sexual events” for pre-menopausal women with ‘Hypoactive Sexual Desire Disorder’ known as HSDD. Many individuals claim that HSDD does not exist, and that women may not suffer from any sort of sexual dysfunction, but instead that it is all in their heads. Therefore, the introduction of Flibanserin has sparked a lot of controversy in the pharmaceutical industry. Currently, Flibanserin / Girosa are not approved for sale in any country, but everyone is working hard to change this. Please stay tuned for additional updates and information.

Some women are taught to stay away from sex or not talk about it in their younger years. Sensuality and sexuality play a vital role in women’s health and when women are educated to believe they must conform to certain sexual beliefs, those beliefs are hard to change. Those beliefs are discussed in the Journal of the American Medical Association, which reported that forty three percent of American women have some form of female sexual dysfunction (FSD).

The truth is sexual pleasure comes with physical, as well as emotional health benefits, and it’s never too late to reap the rewards of sexual activity. In order to enjoy the benefits women must understand how their libido works, and what they can do to counteract the symptoms of FSD at any age. It’s time to stop thinking about sex as a guilty pleasure, and start allowing your sexual emotions to flow freely through your body when the time is right. There are countless female sexual enhancement products on the market that can alleviate symptoms like dryness in the vagina, a low sex drive, pain during intercourse, and the inability to reach an orgasm during intercourse at any stage in life.

When you mentally take control of your sex life your breathing, as well as heart rate increases, because the amount of adrenaline you secrete into the bloodstream increases. The production of other sexual hormones like prolactin, DHEA, testosterone, and noradrenaline also increases. All of those hormones have cardioprotective benefits. Once an orgasm is achieved women as well as men release oxytocin, which is the hormone that lowers blood pressure.

A recent study included 900 men between the ages of 45 and 59. The report shows that having sex two or three times a week helps lower the risk of strokes and heart attacks. Women weren’t included in that study but it shows that the chemical reactions caused by healthy sexual activity is present in both genders.

Other Health Benefits from a Healthy Sex Life

Most everyone who has enjoyed sexual activity realizes that sex definitely improves sleep. After sex our bodies are relaxed and it’s easy to doze off. Sex also improves the benefits of exercise, and is in itself a very healthy form of exercise. Some studies even indicate that sex helps relieve pain. Women in two studies found that their tolerance to pain increases as sexual stimulation increases.

Sex also improves your mood, and certainly decreases depression. That’s why it’s important to find a female sexual enhancement supplement if you’re experiencing any symptoms of FSD. Studies on the relationship between female sexual enhancement supplements and a healthy and active sex life all say if you’re not enjoying sex, you’re missing out on a very important aspect of life.

Girosa is the thought to be proposed name of the Flibanserin drug, currently under clinical test by the Boehringer Ingelheim GmbH German pharmaceutical company. The product line is surrounded by great secrecy and little information is to be found on it. There is a very good reason for this secrecy, as it is anticipated that the market for this so-called female Viagra has a value of roughly $30 million dollars sales per year. The drug has been development and test for some years now, and it has been generally referred to as Flibanserin. However, according to some rumors, the official name of the product will be Girosa after its acceptance for us in the United States.

What is this drug?

Basically, Girosa is a non-hormonal drug consisting of dopamine or D4 cereptors and serotonin receptors also known as 5-HT. Paradoxically, it has been originally developed as an antidepressant, but it seems that when improvements in female sexual desire were reported, the company saw the opportunity for much higher profits in this specific area compared to the much crowded mood enhancer segment. This drug increases the dopamine level in the female body, which is to a certain degree responsible for libido and arousal and thus it might be helpful in pre-menopausal Hypo Sexual Desire Disorder – HSDD, or Female Sexual Dysfunction – FSD. Well, in any case that is the declared target market and objective of the end product.

Interestingly, Boehringer Ingelheim GmbH is not fully sure about how the positive effect on sexual desire arises from Flibanserin, but they are reposting positive results from all their four clinical tests that have involved more than 5,000 women in over 220 clinics across the world. As BioSante is planning to get FDA approval for LibiGel within the next 18 months, Boehringer is also expecting to have FDA approval for medical use in the United States in the near future. Targeting the women Viagra market, it is evident how a multi-million dollar industry for men can have a trickle effect on the market for women, especially if we take in consideration the estimation of scientist and doctors that around 40% of women in the United States experience some symptom of HSDD or FSD.

Flibanserin is a new drug currently under inspection developed for the prevention of woman HSDD – Hypoactive Sexual Desire Disorder. HSDD is a fairly new medical name for physically healthy woman experiencing low libido or a highly decreased sexual desire. According to some conducted studies, 10%-20% of women are experiencing such problems and some even claim HSDD outnumbers men with some kind of sexual problems. Flibanserin is a 5-HT serotonin receptor agonist and dopamine D4 receptor partial agonist, a Non-Hormonal agent that basically increases the level of dopamine and noradrenalin and in the same lowers the serotonin level in the brain. This process apparently positively influences the sexual desire of women with otherwise low libido. The main advantage of this Non-Hormonal drug lies in fact that is has no side effects commonly associated with various hormonal treatments such as negatively altered mood.

Flibanserin, or on its believed trademark name Girosa, produced by a German pharmaceutical company, Boehringer Ingelheim GmbH, was initially developed as an anti-depressant, but after some tests it turned out to be a deficient depression treatment. In the same way Viagra® was also originally developed as a treatment for high blood pressure and angina (a type of heart condition). While females were asked about their experimental experiences for depression, a high number of them remarked a surprising positive side effect from the use of Flibanserin. Most women reported an increased sexual interest and more general satisfying sexual experience than before. Apparently some women involved in the trials did not want to stop the experiment based just on this fact, which resulted in the company to clinically test this new agent for precisely this reason. Is it possible for this drug to really amplify the sexual desire of women?

The reported side effects of the drug were generally low to modest, including some level of anxiety, dizziness, insomnia, fatigue, dry mouth or nausea. Not all individuals involved in the study reported having all these side effects but there were more times reported as the placebo group. As this is a rather new compound there are no long term studies regarding these possible side effects.

Carried out by volunteers, FDA – Federal Drug Administration – clinical trials consists of a succession of tests, experiments and surveys with the purpose of gathering safety information concerning drugs and similar materials. It is an extended process and clinical trials are performed after a large number of tests have been conducted and plenty of information has been collected and considered as acceptable. From that point on, the Health Authority and Ethics Committee give the approval stamp to the country that performed the trials.

Nevertheless, a great deal of work is required before getting to the last final step. As FDA clinical trials are very expensive, in the first stage, only a reduced number of volunteers are selected to start the trials with. The number of people involved in the studies might vary because of certain factors, such as the product itself or the current development stage of the product. If the first set of trials goes well, the number of involved volunteers will rise as well, in order to match up the product in question to an already prescribed drug. The extent of FDA clinical trials might be different from case to case, varying from one single center to dozens.

Based on the United Stated National Institute of Health, there are currently five types of clinical trials, as they follow:

Treatment Trials - experimenting new drug combinations, radical methods regarding surgery and new treatments.

Screening Trials – experimenting health conditions and illnesses.

Supportive Care Trials – experimenting and searching ways to improve the quality of life of people with chronic diseases.

Prevention Trials – experimenting ways to stop some diseases from reappearing or stopping them for good through a different lifestyle and/or certain medications.

Compassionate Use Trials – being the last option with the FDA personally evaluating each case, one by one, to determine the necessity of these tests. In such case, patients who previously had undesirable or unsuccessful remedies will be provided with untried therapy.

In most cases, nearly all FDA clinical studies are conducted in connection with some experimental drug. Once the decision has been made, volunteers will go through three different phases, as they follow:

Phase I Clinical Studies. This is the first phase of the process and only deals with the first time the drug is used and how safe or unsafely the drug is. These studies are generally conducted in a hospital on a certain number of volunteers, varying from 20 to 100. The studies are conducted in a hospital because the involved volunteers can be easily monitored and can get proper treatment if something goes wrong.

Phase II Clinical Studies. This is an intermediary phase and it is carried out only after it has been confirmed that the drug is safe to use by any healthy individuals. The drug is now tested by volunteers suffering from the disease or medical condition the drug is anticipated to heal or improve. This phase is generally longer as the first phase, ranging from a couple of months to several years, while the number of volunteers involved in these trials might start at 200 and easily rising to even more. As soon as these are completed, FDA must evaluate the results to compare and contrast the data concerning the safety, dosage and efficiency of the drug. Regarding the success rate, statistics shows that roughly 1/3 of every tested experimental drug finishes Phase I and Phase II.

Phase III Clinical Studies. It is the last and final phase of the process lasting for several years with the drug tested on from 500 to 2,000 volunteers suffering from the disease or medical condition related to the drug in question. Similarly to Phase II clinical studies, these also require FDA evaluation for a better comprehension of the efficiency, benefits, disadvantages or any possible side effects of the drugs in question. In most cases, the rate of completed studies at this phase is about 70%-90%. For instance, flibanserin is one of these drugs.

Drug Name: Flibanserin
Drug Creator: Boehringer Ingelheim Pharmaceuticals
Clinical Trial ID: NCT00996164

Flibanserin’s effects are aimed at treating psychological dysfunctions of a sexual nature. It is currently undergoing part of the Phase III Clinical Trials with the Food and Drug Administration. A number of participants are taking Flibanserin, while another group is given a placebo. This helps test the actual effectiveness of the drug from an unbiased, objective standpoint, since participants do not know if they are actually taking the drug or not. This process labels the type of study as Interventional, which is the most common.

The design of the study aims to support the scientific method by randomly selecting participants who meet the necessary criteria, making the study double-blind and adding a parallel assignment, and finally, measuring the safety and efficacy of Flibanserin.

Flibanserin’s Phase III Clinical Trial lasts for approximately twenty-four weeks. It began in October of 2009 and ends in February of 2011. The length of the process is due to all the necessary finish touches, data analysis, etc.

The Clinical Trial for Flibanserin will test to see if the participants had an increase in sexually-satisfying experiences. Approximately 900 women between the ages of 18 and 55 are taking part in this study. Those who have been given Flibanserin are issued a 100 mg dosage.

There are more than a few women out there that suffer from a loss of their female libido. It’s important not to confuse a low libido with an outright lack of ability to achieve an orgasm. The problem with having a low libido is that it is often a result of sexual thoughts becoming less frequent, arousal being slowed – resulting in an increased time to reach climax, a psychological reluctance to engage in sexual activity, etc. The list, unfortunately, goes on.

Studies show that approximately one-third of the female population will, at some time or another, experience a lack of libido. There is a vast array of reasons for this to occur, and they are both physical and psychological. Let’s take a look at some of the most common causes.

Female Loss of Libido: Physical Causes
Pain During Intercourse or other Sexual Activity: When a woman experiences an uncomfortable feeling or any sort of pain, they often wish to no longer initiate sexual activity for a period of time. This is a subconscious effect. Pain may also stem from health complications like a cyst or any type of infection or disease.

Childbirth: After the birth of a child, hormone levels in a woman’s body are out of whack. This is an extremely common reason why women have a lower libido. Additionally, unpleasant trauma caused by labor itself may have a similar effect.

Obesity: Women who are classified as obese are often found to be lacking a variety of sex hormones, which results in a disinterest in sexual activity.

Pregnancy: Much like childbirth, hormones are affected throughout the pregnancy period.

Illness: Diabetes and other serious health problems may spawn several different causes for a lack of sexual interest, such as dryness in the vagina, nerve damage, and hormonal imbalance.

Alcoholism: Contrary to popular belief, alcohol’s effects on the body DECREASE a human being’s sex drive and hinder performance.

Drug Use: Illegal substances (and even prescription / over-the-counter medication) sometimes have the ability to counter-act a woman’s sex drive.

Menopause: Last but not least is the change of life. While studies are not conclusive on whether or not menopause diminishes female libido, it is important to consider this anyway. Better safe than sorry.

A low libido is not only caused by physical issues, but by psychological ones as well! In fact, it is often much more common for a woman to be suffering from a lack of sexual desire due to a psychological cause, over a physical one.

Female Loss of Libido: Psychological Causes
A Rocky Relationship: Our quality of life is often directly related to the quality of the relationship that exists between ourselves and our partner. If your head is cluttered with pressing issues related to your relationship or marriage, you won’t be as interested in sex.

The Bills, Chores, etc: The infamous lifestyle stressors such as paying the bills, cleaning the house, managing life – these can be the cause of sexual dysfunction in women.

Anxiety, Depression, Loss of Interest: These are probably the issues with the strongest effect on the sex drive. You may consider seeking medical counsel to have these problems rectified right away. When being prescribed a medication, inquire as to the potential effect the drugs themselves may have on your sex live.

Abuse: Sexual, Emotional or Physical – Past or Present: Obviously such encounters during any point in your life will have an effect on your ability to develop an interest in sex.

Flibanserin, or BIMT – 17, is a drug developed by the Boehringer Ingelheim GmbH pharmaceutical company and it is currently inspected as a drug for women with reduced sexual desire. This drug is a 5-HT1A serotonin receptor agonist and 5-HT2A serotonin receptor antagonist and also a dopamine D4 receptor partial agonist originally researched to serve as an anti-depressant pharmaceutical drug. The Viagra effects of the Flibanserin were accidentally discovered after being tested as an anti-depressant.

The Boehringer Ingelheim company stated on November 16, 2009, that the late-stage tests revealed the drug endorsed sexual desire and was responsible for a significantly improved number of “satisfying sexual events” of women with unusually low libido.

The final outcome of four Phase III researches involving over 2,000 pre-menopausal women with some form of HSDD – Hypoactive Sexual Desire Disorder were made public in Lyon, Franceat the congress of the European Society for Sexual Medicine. Women taking this drug reported that the average number of times they experienced “satisfying sexual experience” grew from 2.8 to 4.5 per month, while women taking the placebo reported the number grow to 3.7 times per month. Flibanserin has to be taken once a day and allowing up to four weeks to produce its effects. In the case of animals, the drug increases the level of noradrenalin and dopamine, and decreases the level of serotonin in their organism.

Flibanserin directly influences the chemical reactions sequence in the brain thought to activate sexual desire. The action mechanism of this drug acts differently as the Intrinsa hormone patch of Procter & Gamble that targets post-menopausal women.

Starting from November, 2009, Phase III clinical tests are evaluating safety and efficacy aspects with both pre- and post-menopausal women.

Currently, it is believed that Flibanserin works to increase sexual desire by simply reducing the level of serotonin in the brain, which results in a reduction of inhibitory effects that are likely to be the cause of the lack of sexual desire. However, this information has not been totally verified and is still, really, just a hypothesis.

Initially, Flibanserin was introduced to work as an anti-depressant back in the 1990s – but testing proved that it was ineffective. Michael Sand, the Director of Clinical Research for Boehringer-Ingelheim, the producer of Flibanserin, stated, “We saw an increase in sexually satisfying events, an increase in desire and a decrease in distress. When we look at this against a backdrop of a common and distressing problem that affects 1 of 10 women and for which no treatment exists, well, we are feeling very positive.”

So, do the results agree? In the clinical trials, women who were taking Flibanserin increased their ‘sexually satisfying events’ by 1.7 a month, while those under the effects of the Placebo had 1 more event a month. However, some experts believe that treating Hypoactive Sexual Desire Disorder (HSDD) with a drug may not be the best solution. They believe that it would be better to treat the issues in the lives of women that are effecting their sexual desire, rather than ignoring them and switching to a medical treatment.

Viagra for women? Not quite. Viagra works in men by producing an erection through the process of increasing the flow to blood to the penis. Though, the issue in women, is that they entirely lack the desire to have sex and are therefore physically unable – they lose an interest in sex altogether.

Scientists believe that women affected by Hypoactive Sexual Desire Disorder may suffer from low levels of testosterone. Many women in the United States currently utilize testosterone treatments to remedy their low libidos. However, the Food and Drug Administration has not approved any such treatments for HSDD due to potential safety concerns. One drug that is especially interesting in LibiGel, produced by BioSante, which is a testosterone gel undergoing Phase III Clinical Trials.

BIMT-17, commonly known as Flibanserin, is a new pharmaceutical drug developed by Boehringer Ingelheim. Flibanserin is suspected of having a positive effect on women who suffer from decreased desire for sexual activity. The drug is, among other things, a dopamine D4 receptor partial agonist that was originally designed to function as an anti-depressant.

There is currently very little publicly available data regarding Flibanserin. However, on the 16th of November in 2009, Flibanserin’s producer, Boehringer Ingelheim, had reported that Flibanserin promoted the desire for sexual activity and raised the number of ‘sexually satisfying’ moments in the lives of women who were plagued with irregularly low libido, in late-stage trials.

Phase III studies were conducted with over two thousand pre-menopausal females who were affected by HSDD: Hypoactive Sexual Desire Disorder. Women who were under the effects of Flibanserin claimed to have had sexually satisfying events more often than before using the drug. In fact, a raise from 2.8 to 4.5 times a month was shown by the results. On the other hand, women who were under the effects of a placebo claimed that a raise to approximately 3.7 times per month. Current information estimates that Flibanserin must be taken for up to twenty eight days before an effect appears.

The last reports on Flibanserin, back in November of 2009, stated that the Phase III clinial trials for the drug are ‘assessing safety and efficacy’ in both pre- and post-menopausal females.

Scientific Reference Information:
IUPAC Designation: 1-[2-[4-(3-trifluoromethyl phenyl) piperazin-1-yl] ethyl] benzimidazol- [1H]-2-one
CAS Number: 167933-07-5
PubChem: 6918248
Chemical Forumla: C20H21F3N4O