Efficacy and Safety of Testogel® in Men With Partial Androgen Deficiency of Aging Males (PADAM)

PHASE3CompletedINTERVENTIONAL
Enrollment

363

Participants

Timeline

Start Date

September 30, 2004

Primary Completion Date

September 30, 2006

Study Completion Date

October 31, 2007

Conditions
Androgens (Deficiency)Male
Interventions
DRUG

Testogel (Testosterone, BAYV001915)

50mg (5g gel sachet), 75mg (5g+2.5g sachet) or 100mg (2x5g sachet) per day applied to the skin of the shoulders, arms or abdomen for 18 months

DRUG

Placebo

5g gel sachet, 5g+2.5g sachet or 2x5g sachets per day applied to the skin of the shoulders, arms or abdomen for 6 months followed by 12 months treatment with testosterone 1% gel as described for arm 1

Trial Locations (30)

1021

Vienna

1090

Vienna

5020

Salzburg

6020

Innsbruck

8036

Graz

14186

Stockholm

20123

Milan

20502

Malmo

28007

Madrid

33521

Tampere

39310

Magdeburg

41346

Gothenburg

53105

Bonn

80131

Napoli

90100

Oulu

00260

Helsinki

01067

Dresden

04103

Leipzig

06112

Halle

Unknown

Dublin

00161

Roma

00186

Roma

08907

L'Hospitalet de Llobregat

08025

Barcelona

RG2 7AG

Reading

WN1 1XX

Wigan

CF14 5GJ

Cardiff

EC1A 7BE

London

NW3 2QG

London

S5 7AU

Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY