Navigation Links
Indevus Announces Submission of New Drug Application
Date:8/28/2007

oncentration of 2500 ng/dL, no more than 5% of patients should exceed a concentration of 1800 ng/dL, and no more than 15% of patients should exceed a concentration of 1500 ng/dL.

In addition, secondary outcomes included measurements evaluating the general health and well-being of the patients by questionnaires and assessment tools.

Phase III Study Findings

The trial randomized a total of 237 male hypogonadal patients (117 patients treated in the 1000 mg dose arm and 120 patients treated in the 750 mg dose arm). The patient completion rate of all 5 injections with NEBIDO was over 80%, demonstrating very high treatment compliance for a one-year study. Reasons for discontinuation were similar between the treatment groups.

Of the 97 patients in the 1000 mg arm receiving their steady-state injection, 94% had a Cavg over the course of the 12-week period that was within the normal range, demonstrating that treatment with NEBIDO successfully maintained therapeutic testosterone levels in hypogonadal men with injections given only once every 12 weeks (just 4 to 5 times per year). Further, no patients in the 1000 mg arm exceeded a testosterone concentration of 2500 ng/dL; four of 97 (4.1%) patients had a peak level over 1800 ng/dL; and 11 of 97 (11.3%) patients had a peak level exceeding 1500 ng/dL. The duration of time any patient had a concentration over these Cmax thresholds was brief.

Of the 102 patients in the 750 mg arm receiving their fourth injection, 86% had a Cavg within the normal range. No patients in the 750 mg arm exceeded a testosterone level of either 2500 ng/dL or 1800 ng/dL, and only four of 102 (3.9%) patients had a peak level exceeding 1500 ng/dL. For those few patients exceeding the 1500 ng/dL threshold, the duration of time above the threshold was brief.

Both treatment arms demonstrated improvements from baseline in key secondary clinical outcome variables.

Both doses of the drug were well-tolerated as indicated b
'/>"/>

SOURCE Indevus Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Indevus Announces Presentation of Pagoclone Data at 47th Annual New Clinical Drug Evaluation Unit Meeting
2. Indevus Reports Positive Data From Phase III NEBIDO Trial
3. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
4. Sygnis Pharma AG announces date for presentation of clinical results
5. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
6. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
7. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
8. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
9. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
10. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
11. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/27/2015)... -- WuXi PharmaTech (Cayman) Inc. (NYSE:  WX), a leading ... pharmaceutical, biotechnology, and medical device industries with operations in ... United States , congratulates our partner TaiMed Biologics ... for ibalizumab (TMB355). The FDA designates a drug as ... in combination with one or more other drugs, to ...
(Date:2/27/2015)... , Feb. 27, 2015  Acsis Inc., the market ... solutions, announced today that John DiPalo , Acsis, ... Supply & Demand Chain Executive 2015 Provider Pro ... are leading initiatives to help prepare their companies, and ... business climate. This year,s list of Provider Pros to ...
(Date:2/27/2015)... Securities lawyers at Dunnam & Dunnam ... (NASDAQ: SLXP ) in connection with a ... are encouraged to contact attorney Hamilton Lindley by ... upon the shareholder value of the transaction. Under terms ... $158.00 per share in cash. At least one analyst ...
Breaking Medicine Technology:WuXi Congratulates TaiMed Biologics on Receiving Breakthrough Therapy Designation from U.S. FDA 2Acsis CSO John DiPalo Named Supply & Demand Chain Executive 2015 Pro to Know 2
... HOUSTON, Sept. 22 On an exploration mission, an astronaut ... the spacecraft speeds to its destination. The ensuing scene is ... grasp on the situation and provide appropriate treatment. Efficient use ... and death. Engineers funded by the National Space ...
... Sept. 22 AlloSource, one of the nation,s largest non-profit ... in surgical procedures and the world,s largest processor of live ... company as judged by the ColoradoBiz Top Company ... each year for the past decade, AlloSource saved and enhanced ...
Cached Medicine Technology:Space-Age Device to Deliver More Efficient Health Care on Earth and Above 2Space-Age Device to Deliver More Efficient Health Care on Earth and Above 3AlloSource Named Colorado's Top Healthcare Company 2
(Date:3/1/2015)... CrossFit Attollo is a CrossFit gym located in Vancouver ... to new members. Now through the end of March ... will receive their fourth month half off. , ... The three month contract is only $264, dropping the price ... comes in at only $55. The special saves new members ...
(Date:2/28/2015)... February 28, 2015 In recent years Medical ... of practicing physicians as a way for them to expand ... regarding Cannabis as medicine. Since the FDA still lists Cannabis ... resources available to licensed physicians that can help guide ... Dr. Deborah Malka in Santa Cruz, CA is a ...
(Date:2/28/2015)... OR (PRWEB) February 28, 2015 In ... Duncan Fletcher of Game Change Athlete ... Shannon Leinert about the benefits of athlete development and ... some of the unique challenges that athletes face and ... and future success. , Fletcher became involved in athlete ...
(Date:2/28/2015)... 2015 With their commitment to achieving ... an additional exercise to their already robust library of ... most commonly known as, is often performed on a ... executed in a relatively safe manner and can be ... The full description of “Rope Pulls” is located in ...
(Date:2/28/2015)... Portland, Oregon (PRWEB) February 28, 2015 ... Portland, Oregon, is offering a new special. Throughout ... denture relines. , This service ... from sleep problems and pain. Patients may notice certain ... and need relining. These symptoms include: , 1.    Pain, ...
Breaking Medicine News(10 mins):Health News:CrossFit Gym in Vancouver WA Offers Spring Special 2Health News:Reputable Cannabis Doctor In Santa Cruz and Monterey Joins the Medical Cannabis Network 2Health News:SCI TV Covers Athlete Development with Duncan Fletcher 2Health News:SCI TV Covers Athlete Development with Duncan Fletcher 3Health News:Classic Denture Center in Portland Oregon is Offering March Discount 2
... have found a new family of therapeutic agents that ... growth of breast cancer cells. The results of the ... The Endocrine Society,s 90th Annual Meeting in San Francisco. ... therapeutic called TPBM and related compounds are likely to ...
... have discovered a new family of agents that inhibit ... described today at a meeting of the Endocrine Society, ... to combat estrogen-dependent breast cancers. , "This cell-based study ... to be effective in tumors that remain dependent on ...
... treatments, researchers say , , MONDAY, June 16 (HealthDay News) ... that might one day be added to the armamentarium ... "This is a potential new approach to treating hormonally ... officer of the American Cancer Society. "If it proves ...
... 16 The National Center for Healthcare,Leadership (NCHL) ... MD, chief,executive officer of Denver Health, as the ... her significant and lasting contributions,to healthcare. Under her ... system that achieves organizational,excellence while treating at-risk populations, ...
... S.C., June 16 The planned,Presbyterian College school of ... the dean of the school of pharmacy and assistant,provost ... Charleston,W. Va. has accepted the college,s offer to become ... developing the first school of pharmacy in,Upstate South Carolina., ...
... of RU-486,s companion drug misoprostol is safe, but vaginal use ... a drug given with RU-486 to terminate a pregnancy may ... in women taking the drugs since 2000, a study by ... is FDA-approved to be taken by mouth along with RU-486 ...
Cached Medicine News:Health News:Future hope for patients with breast cancers resistant to tamoxifen 2Health News:Team discovers new inhibitors of estrogen-dependent breast cancer cells 2Health News:New Molecule Discovery Shows Promise Against Tamoxifen-Resistant Breast Cancers 2Health News:Denver Health's Dr. Patricia Gabow Receives NCHL's 2008 National Healthcare Leadership Award 2Health News:Denver Health's Dr. Patricia Gabow Receives NCHL's 2008 National Healthcare Leadership Award 3Health News:Denver Health's Dr. Patricia Gabow Receives NCHL's 2008 National Healthcare Leadership Award 4Health News:Presbyterian College Announces First Dean of New Pharmacy School 2Health News:Presbyterian College Announces First Dean of New Pharmacy School 3Health News:Abortion drug's off-label use may have led to deaths 2Health News:Abortion drug's off-label use may have led to deaths 3
... eyes, oral. Marked with recommended tube ... line. Graduated. Single use. For improved ... of the tube by incorporating a ... the anatomical situation at body temperature. ...
... stylet inside. Sterile, Latex Free, Single ... tube with a preloaded Slick® Stylet ... time and storage space. The stylet ... and has a stopper to help ...
Ruschelit® PVC. Murphy eye-nasoral. Black positioning ring. High volume/low pressure cuff. X-ray opaque line. Graduated. Single use....
Ruschelit® PVC. Magill tip-nasoral. Black positioning ring. High volume/low pressure cuff. X-ray opaque line. Graduated. Single use....
Medicine Products: