The first ever clinical trial in China, involving more than 6,000 patients with erectile dysfunction, was completed last month by the National Pharmaceutical University Medical Centre (NPUMC), Gurgaon.
The study, which is expected to start in April, involved a random sample of 2,800 people aged 18 to 64 years old.
The study, which was carried out between April and June in the New Clinical Trials Unit, was designed to assess the safety and tolerability of sildenafil citrate (Viagra) in patients with erectile dysfunction and to determine if this drug could improve symptoms and improve sexual function.
The results will be published in the second edition of theInternational Journal of Sexual Medicine.
The results are expected to be published in theJournal of Sexual Medicinein August, after a second study is being carried out in China.
Sildenafil, the first drug approved for treating erectile dysfunction, is marketed by Pfizer, which is the world’s biggest pharmaceutical company. The company has a combined sales of US$2.6bn.
A Pfizer spokesperson toldThe Timesthat it has taken a number of steps to improve its reputation for safety and efficacy.
The results, which were published in the, included:
According to Pfizer, the data were not sufficient to justify its decision to discontinue the treatment.
In the first study of patients with erectile dysfunction who did not have any adverse effects, the patients had a mean age of 49 years. The patients were randomly assigned to one of three groups:
The main finding of the study was that sildenafil citrate improved the erectile function of patients who did not have erectile dysfunction.
The researchers said that their study was designed to provide preliminary evidence for the benefits of sildenafil citrate as a treatment option for erectile dysfunction.
The study will be carried out at NPUMC and will last between April and June.
The studyA total of 6,600 men aged 18 to 64 years old were enrolled and randomly assigned to treatment with sildenafil (Viagra®) or placebo. The study was designed to evaluate the safety of sildenafil, a non-surgical drug that has been used for many years for the treatment of erectile dysfunction.
The men were randomized to treatment with either a placebo or sildenafil citrate 100 mg taken three times a day for eight days.
They were assessed for their sexual function, erection quality and erectile function using the International Index of Erectile Function (IIEF). The IIEF consists of four domains:
The researchers said that the results of the study did not provide any new information about the efficacy or safety of sildenafil citrate in treating ED.
The study was also run in the absence of a specific grant from NPUMC.
The researchers noted that sildenafil citrate is a new drug and that other treatments for ED have yet to be approved by the FDA.
Viagra has been shown to cause some mild side effects. Talk to your health care provider if these do not go away within a few days. If you begin to experience more serious reactions, seek medical attention immediately.
Common side effects reported from Viagra use include:
More severe side effects include:
If you experience any of these side effects, seek medical attention immediately. These are symptoms of a severe adverse reaction to this medication that require immediate treatment.
As with all prescription medications, inform your doctor of any medical conditions you currently manage. Tell them about any and all medications, prescription drugs, and supplements you are taking before starting treatment with Viagra. Viagra can interact with bodily substances, causing potentially serious adverse reactions.
Specifically, you should inform your health care provider of any nitrate medication you are taking. Remember to mention any herbal products you use, especially St. John’s wort.
In addition, let your doctor know if you have recently had heart surgery or experience chest pain during sex. If you experience any changes in your heartbeat or chest pain during sex, contact your health care provider immediately.
as soon as possible (ormonothry ipsateIGesia)as prescribed (chekk) (NDC 46844-01-01)In addition, let your health care provider know if you have ever had an allergic reaction to Viagra or any other medication during sex. If you do, contact your health care provider immediately.
as soon as possible (ideal time)As with all prescription medications, inform your doctor of any medical conditions you may have been iniculty closed up about before starting Viagra. This includesaundice, changes in vision, back pain, kidney problems, and sudden loss of vision.
as soon as possible ( Ideally, one month before sexual activity.Nonprescriptionalment is not advised.Viagra can interact with medications that you are prescribed to be taken by people with certain conditions, including:
If you experience any unusual thoughts or symptoms while taking Viagra, contact your health care provider immediately.
as soon as possible ( timeframe before sex)If you notice any other changes in your behavior, you should contact your health care provider immediately.
as soon as possible ( More than 4 hours after taking Viagra )If you have any changes in behavior, sexual problems, or unusual thoughts, contact your health care provider immediately.
Viagra Connect is available in Ireland for erectile dysfunction treatment which does not require a prescription. The first of its kind, Viagra Connect is a safe and discreet over-the-counter medication that can legally be bought online or over the counter in your pharmacy, without a trip to your doctor.
We need to ensure that this medicine is suitable for the person it is intended for. Therefore, it should only be purchased by the person taking it.
You can select your convenient store to collect your product and fill in the online form required.APharmacist will contact you to let you know your product is ready for collection, or you can buy onlineand complete the questions included.
When purchased online, a pharmacist will contact you by phone if they have any further questions and to advise you on the safe use of this medicine. If they are unable to speak to you when required your order may be delayed or the pharmacy medicine part of your order cancelled.
Please ensure your contact details are correct before ordering this medicine.Suitable for
Viagra Connect is for men 18 years and older who have difficulty getting and/or keeping an erection hard enough for sex
Age RestrictionYou must be at least 18 years old to purchase this product.
Directions for use:
Please read the enclosed leaflet carefully before use.
• take 1 tablet approximately one hour before sexual activity• swallow tablet whole with water• do not take more than 1 tablet a dayViagra Connect starts to work within 30-60 minutes. You may take it up to 4 hours before sexual activity.
Hazards and Cautions
Do NOT take if you:
Talk to your pharmacist or doctor before taking if you:
Effect on heart
These effects work immediately after sexual activity. However, the drug may take up to 6 hours to take effect. You should notice an improvement in your erection after taking this medication. This may be due to old age or low blood pressure. You should notice a more serious problem, such as a blood disorder or kidney problems. A deformed penis may also be cause for an increase in sexual desire. Viagra Connect may not be suitable for everyone.
These effects have not been seen after 4 hours of taking Viagra Connect. If you have any questions about Viagra Connect, ask your doctor or pharmacist.
How do I take this medicine?Take it at the same time every day. Please ensure you read the enclosed leaflet before use.
This medicine requires a special diet rich in nitrates to prevent heart-related side effects.
The Food and Drug Administration (FDA) has ordered the online pharmacy, to stop selling the medication in China, the United States, and other countries.
FDA officials are expected to issue a final ruling on Friday. In a statement, they said the FDA has not yet given any reason why the drugs should be removed from sale, but the agency has already made clear that it does not recommend them to consumers in China.
The FDA has also made clear that it does not recommend the sale of the drugs in other countries in Asia and Europe, according to the statement.
“The FDA is committed to ensuring that all medicines used in China are effective, safe, and dispensed under the supervision of the appropriate healthcare professionals,” the agency said in a press release. “We also believe that all drugs approved by the FDA are safe and effective for human use.”
The FDA has also been asked to review a number of other drug interactions and safety warnings issued by the agency, including warnings related to a potentially dangerous drug used to treat HIV. The agency is also expected to make a decision on whether to approve the use of Viagra and Cialis in certain circumstances.
FDA spokeswoman not-an-idea-sorry, Ms. Lea Thompson said: “The agency continues to be committed to protecting consumers from dangerous and potentially harmful drug interactions that may occur during a clinical trial, including when a patient is taking a prescription drug or over the counter product.”
FDA also said that it would not recommend the sale of Viagra or Cialis in China for health reasons, as the company does not have an FDA-approved prescription for these drugs.
“We are pleased that the FDA has not decided to remove these drugs from sale,” said FDA spokesperson Cindy Whitehead. “We will continue to take appropriate steps to ensure the safety and effectiveness of these medications.”
Originally Published: March 6, 2013 at 12:01 AM EST
This article has been corrected to reflect the news and information about the FDA’s decision to halt the sale of the drug in China.The Food and Drug Administration (FDA) has not given reason to believe that these drugs should be removed from sale, but the agency has made clear that it does not recommend the sale of these drugs in other countries in Asia and Europe, according to the statement.The FDA has been asked to review a number of other drug interactions and safety warnings issued by the agency, including warnings related to a potentially dangerous drug used to treat HIV. The FDA is also expected to make a decision on whether to approve the use of Viagra and Cialis in certain circumstances.FDA has been asked to review a number of other drug interactions and safety warnings issued by the agency, including warnings related to a potentially dangerous drug used to treat HIV.“We are pleased that the FDA has not decided to remove these drugs from sale, but the agency has made clear that it does not recommend these drugs to patients in China,” said FDA spokesman Cindy Whitehead.
Stade de France Pharmacy