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:1/23/2015)... Idaho , Jan. 23, 2015  Now available for ... No. 7,849,611) support that prevents ankle sprains by cushioning ... brace, it fits securely around the outside of any ... mobility & comfort while still offering protection against sprains. ...
(Date:1/23/2015)... , Jan. 23, 2015   Leatt Corporation  (OTCQB: LEAT), ... equipment for all forms of sports, including extreme motor ... brace, announced today that the UISP Lega Motociclismo Lombardia, ... all riders to wear a neck brace during its ...
(Date:1/23/2015)... BOSTON , January 23, 2015 Heptares ... is delighted to announce that the Malcolm Campbell ... Congreve (Vice President of Chemistry), Fiona Marshall ... (Chief Executive Officer and co-founder) for the seminal contributions to ...
Breaking Medicine Technology:The Armor1 Ankle Roll Guard is the New Breakthrough Solution for Ankle Sprain Prevention! 2Leatt Announces Neck Braces Now Required For Motocross/Minicross Racing In Italy 2Leatt Announces Neck Braces Now Required For Motocross/Minicross Racing In Italy 3Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 2Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 3Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 4
... N.J., May 26, 2011 Johnson & Johnson (NYSE: ... its Pharmaceuticals business at a meeting with the investment ... and pharmaceuticals segment will review how the business plans ... needs and outpace pharmaceutical market growth with an optimized ...
... Pharmaceuticals, Inc. (NASDAQ: AMLN ) ("Amylin" or "the ... the Southern District of California issued a temporary restraining order ... ) ("Lilly") relating to its litigation with respect to the ... District Court restrained Lilly from proceeding with its plans to ...
Cached Medicine Technology:Johnson & Johnson Highlights Strategies for Growth Through Differentiated Medicines, Transformational Pipeline and Global Product Launches 2Johnson & Johnson Highlights Strategies for Growth Through Differentiated Medicines, Transformational Pipeline and Global Product Launches 3Johnson & Johnson Highlights Strategies for Growth Through Differentiated Medicines, Transformational Pipeline and Global Product Launches 4Johnson & Johnson Highlights Strategies for Growth Through Differentiated Medicines, Transformational Pipeline and Global Product Launches 5Amylin Pharmaceuticals Obtains Temporary Restraining Order Against Eli Lilly 2Amylin Pharmaceuticals Obtains Temporary Restraining Order Against Eli Lilly 3Amylin Pharmaceuticals Obtains Temporary Restraining Order Against Eli Lilly 4
(Date:1/22/2015)... TX (PRWEB) January 22, 2015 The Incredible ... Bodybuilder Ben Pakulski to increase lean muscle by up to ... has caught the attention of HealthyandFitZone.com’s Stan Stevenson, prompting an ... that it is a step-by-step, scientific diet formula that allows ...
(Date:1/22/2015)... Juvent Sports ( http://www.juventsports.com ) and David ... Show to bestow a Juvent Sports Achievement award upon ... McKitrick. The award commemorated and congratulated McKitrick for her ... won her first amateur tournament in 1979 and most ...
(Date:1/22/2015)... Carinsurancesavings.biz has released a new blog post presenting the ... , Purchasing an accidental death and dismemberment rider for ... of rider provides benefits if the insured dies in an ... form of life insurance. , AD&D is not expensive ...
(Date:1/22/2015)... January 22, 2015 IsoComforter, Inc. has introduced ... with patented IsoTube design to treat specific body parts and ... most progressive and easy to use patented cold therapy machine ... sports related orthopedic and muscle injuries. IsoComforter has become ...
(Date:1/22/2015)... 2015 JJsHouse.com is a famous dress online ... business announces its latest collection of wedding dresses , ... important issue is the wedding dress on your big day; ... woman’s life. Every bride wants to find the most suitable ...
Breaking Medicine News(10 mins):Health News:The Incredible Bulk: Review Examining Ben Pakulski’s Brand New Bulking Muscle Building Diet Program Released 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 3Health News:Accidental Death and Dismemberment Insurance Can Be Purchased at Low Prices Online 2Health News:IsoComforter Introduces Best of Class Cold Therapy Product to the Worldwide Market 2Health News:Find The Most Suitable Wedding Dress At JJsHouse.com 2
... YORK, Dec. 17 Cognition Pharmaceuticals LLC today announced ... C105 (l amphetamine sulfate) on 151 Multiple Sclerosis patients ... In the six-week placebo-controlled study, Cognition Pharmaceuticals ... secondary outcome measures of memory and learning, including the ...
... The GT2™ by ZEISS Combines ZEISS,s Precision Progressive Lenses and Transitions® ... ... Diego, CA (PRWEB) December 17, 2008 -- Two of the most ... about the latest in leading-edge eyewear., , ,Carl Zeiss Vision, a ...
... to some countries where data doesn,t match WHO ... About 7 million fewer children are immunized against ... nations and World Health Organization/UNICEF estimates report, a ... funding for vaccinations based on these estimates, the ...
... and tissue recovery organization for Northeast Ohio, participated with,the ... first,near total face transplant in the United States. , ... is from LifeBanc Chief Executive Officer Gordon,Bowen. , ... mission of helping to improve and save the,lives of ...
... JEFFERSON CITY, Mo., Dec. 17 The Missouri ... the Substance Abuse and,Mental Health Services Administration (SAMHSA) ... Service Awards. These awards "recognize,exemplary implementation of ... treat mental illnesses and substance abuse"(1). , ...
... COLUMBIA, Mo. All spiritual experiences are based in ... according to a University of Missouri neuropsychologist. An MU ... proposes spiritual experiences associated with selflessness are related to ... brain. The study is one of the first to ...
Cached Medicine News:Health News:Cognition Pharmaceuticals Announces Positive Memory Results for Phase II Trial of C105 in Multiple Sclerosis 2Health News:Cognition Pharmaceuticals Announces Positive Memory Results for Phase II Trial of C105 in Multiple Sclerosis 3Health News:Cognition Pharmaceuticals Announces Positive Memory Results for Phase II Trial of C105 in Multiple Sclerosis 4Health News:Carl Zeiss Vision and Transitions Optical Inc. Promote Pioneering Eyewear to Consumers 2Health News:Independent Audit of Global Child Immunizations Urged 2Health News:LifeBanc Assists Cleveland Clinic in First Near Total Face Transplant in the United States 2Health News:Missouri Behavioral Pharmacy Management Program Receives 2008 SAMHSA Science and Service Award 2Health News:Missouri Behavioral Pharmacy Management Program Receives 2008 SAMHSA Science and Service Award 3Health News:Selflessness, core of all major world religions, has neuropsychological connection 2
Malaria device / strip (2 line, P.f.-HRP2 Test)...
High sensitive, specific one step immunochromatographic assay for human infectious disease...
High sensitive, specific one step immunochromatographic assay for human infectious disease...
High sensitive, specific one step immunochromatographic assay for human infectious disease...
Medicine Products: