Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Newly Published Study Showed Axiron® (testosterone) Topical Solution Restored Testosterone Levels to Normal Range in Hypogonadal Men

June 28, 2011 By Bio-Medicine.Org

INDIANAPOLIS, June 28, 2011 /PRNewswire/ — Eli Lilly and
Company (NYSE:
LLY
) announced that a pivotal Phase III Axiron study, published
on the Clinical Endocrinology website, showed that Axiron®
(testosterone) topical solution CIII, when applied to the underarm,
met the primary study objective to restore testosterone levels to
the normal range (300 – 1050 ng/dL) in men with low
testosterone. In addition, secondary outcomes showed that the
treatment of Axiron improved symptoms associated with low
testosterone.

Testosterone deficiency, also known as hypogonadism or low
testosterone, is a clinical condition in which the testicles,
hypothalamus or pituitary gland is affected by disease or damage
that results in inhibiting hormone secretion and testosterone
production.(i)

About the Study

The Phase III open label, 120-day clinical study, conducted in
26 centers throughout the world, assessed the safety,
pharmacokinetics and efficacy of a 2% formulation of testosterone
topical solution (Axiron) applied daily to the underarm.  All
155 men began the study on a 60 mg dose and had their dose adjusted
on Days 45 and 90, if necessary, to maintain their testosterone
levels within the physiological range based on an average serum
testosterone levels tested on Days 15 and 60, respectively.
 On Day 120, of the 138 men for which there was evaluable
data, 84% had an average testosterone concentration within the
normal range (300-1050 ng/dL).  On Day 120, the majority of
the men, 97 subjects, remained on 60 mg starting dose; three men
were on 30 mg; 25 men were on 90 mg; and 10 men were on 120 mg.

The study also assessed the effect of treatment on symptoms
associated with low testosterone as measured by the Psychosexual
Daily Questionnaire.  Improvement in sexual desire and
activity were apparent as early as 15 days (1.9 and 0.93
point

‘/>”/>

SOURCE

Related Articles Read More >

Engineer inspecting artificial hip joint parts in quality control department in orthopaedic factory
Deburring and finishing for beautiful, functional medical devices
A Medtronic HVAD pump opened up to show the inner workings
FDA designates new Medtronic HVAD pump implant recall as Class I
Dexcom One
How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age

DeviceTalks Weekly.

June 24, 2022
How innovative design, commercial strategy is building Cala Trio’s bioelectronic medicine market
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech