HypogonadismNCT01143818
ESPRIT Study in Hypogonadal Men
An observational study of Hypogonadism, run by Abbott at 331 sites in 9 countries.
Trial summary
Observational study with AndroGel®, Testosterone 1% gel therapy (ESPRIT) in hypogonadal men in the community over 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hypogonadism
- What is being tested?
- AndroGel (testosterone gel) 1%
- How many people
- 1,053 participants
- Where
- 331 sitesin 9 countries
- Study dates
- Dec 2007to Aug 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Community
Who may be able to join
- Male patients >= 18 years of age
- Hypogonadism not previously treated with testosterone
- Testosterone deficiency confirmed clinically and biochemically
- Being prescribed AndroGel® 1% in accordance with the local summary of product characteristics
Who cannot join
- According to the contra-indications,
- Unwilling or unable to sign informed consent form
Trial locations and contacts
331 sites in 9 countries.
331 sites in 9 countries
Russia75 sites
Site Ref # / Investigator 59891
Kazan', 420004
Site Ref # / Investigator 59695
Kazan', 420110
Site Ref # / Investigator 59643
Kemerovo, 650061
Site Ref # / Investigator 59697
Kemerovo, 650090
Site Ref # / Investigator 59893
Khabarovsk, 680000
Site Ref # / Investigator 59654
Khabarovsk, 680045
Site Ref # / Investigator 59897
Krasnodar, 350012
Site Ref # / Investigator 59900
Krasnodar, 350018
Site Ref # / Investigator 59675
Krasnoyarsk, 660049
Site Ref # / Investigator 59903
Krasnoyarsk, 66049
Site Ref # / Investigator 59678
Moscow, 105425
Site Ref # / Investigator 59651
Moscow, 109052
Site Ref # / Investigator 59902
Moscow, 109428
Site Ref # / Investigator 59688
Moscow, 109431
Site Ref # / Investigator 59698
Moscow, 115432
Site Ref # / Investigator 59665
Moscow, 11558
Site Ref # / Investigator 59896
Moscow, 117136
Site Ref # / Investigator 59689
Moscow, 117139
Site Ref # / Investigator 59650
Moscow, 119435
Site Ref # / Investigator 59648
Moscow, 125167
Site Ref # / Investigator 59646
Moscow, 127018
Site Ref # / Investigator 59649
Moscow, 127642
Site Ref # / Investigator 59662
Moscow, 129344
Site Ref # / Investigator 59645
Naberezhnye Chelny, 423826
Site Ref # / Investigator 59638
Nizhny Novgorod, 603029
Site Ref # / Investigator 59677
Nizhny Novgorod, 603076
Site Ref # / Investigator 59668
Nizhny Novgorod, 603109
Site Ref # / Investigator 59693
Novosibirsk, 630003
Site Ref # / Investigator 59656
Novosibirsk, 630004
Site Ref # / Investigator 59895
Novosibirsk, 630073
Site Ref # / Investigator 59694
Novosibirsk, 630099
Site Ref # / Investigator 59641
Penza, 440046
Site Ref # / Investigator 59637
Penza, 440061
Site Ref # / Investigator 59657
Penza, 440064
Site Ref # / Investigator 59636
Rostov-on-Don, 344015
Site Ref # / Investigator 59699
Rostov-on-Don, 344029
Site Ref # / Investigator 59655
Rostov-on-Don, 344064
Site Ref # / Investigator 59667
Rostov-on-Don, 344113
Site Ref # / Investigator 54490
Saint Petersburg, 192241
Site Ref # / Investigator 59691
Saint Petersburg, 193091
Site Ref # / Investigator 59640
Saint Petersburg, 194291
Site Ref # / Investigator 59676
Saint Petersburg, 194354
Site Ref # / Investigator 59642
Saint Petersburg, 194358
Site Ref # / Investigator 59700
Saint Petersburg, 196000
Site Ref # / Investigator 59679
Saint Petersburg, 196135
Site Ref # / Investigator 59658
Saint Petersburg, 197198
Site Ref # / Investigator 59672
Samara, 443115
Site Ref # / Investigator 59661
Saratov, 41003
Site Ref # / Investigator 59666
Saratov, 410053
Site Ref # / Investigator 59663
Tolyatti, 445009
Site Ref # / Investigator 59905
Tolyatti, 445011
Site Ref # / Investigator 59653
Tolyatti, 445020
Site Ref # / Investigator 59692
Tomsk, 634021
Site Ref # / Investigator 59690
Tomsk, 634028
Site Ref # / Investigator 59673
Tomsk, 634031
Site Ref # / Investigator 59669
Ufa, 450001
Site Ref # / Investigator 59670
Ufa, 450022
Site Ref # / Investigator 59659
Ufa, 450095
Site Ref # / Investigator 59652
Ufa, 480005
Site Ref # / Investigator 59660
Vladivostok, 690000
Site Ref # / Investigator 59901
Vladivostok, 690000
Site Ref # / Investigator 59639
Vladivostok, 690003
Site Ref # / Investigator 59635
Volgograd, 400001
Site Ref # / Investigator 59892
Volgograd, 400107
Site Ref # / Investigator 59696
Voronezh, 394000
Site Ref # / Investigator 59906
Voronezh, 394000
Site Ref # / Investigator 59671
Voronezh, 394066
Site Ref # / Investigator 59894
Voronezh, 399002
Site Ref # / Investigator 59664
Yaroslavl, 150001
Site Ref # / Investigator 59899
Yaroslavl, 150003
Site Ref # / Investigator 59674
Yaroslavl, 150062
Site Ref # / Investigator 59647
Yekaterinburg, 620000
Site Ref # / Investigator 59904
Yekaterinburg, 620000
Site Ref # / Investigator 59898
Yekaterinburg, 620036
Site Ref # / Investigator 59644
Yekaterinburg, 620146
Saudi Arabia64 sites
Site Ref # / Investigator 59398
Abhā
Site Ref # / Investigator 59405
Dammam, 31411
Site Ref # / Investigator 59406
Dammam, 31488
Site Ref # / Investigator 59388
Dammam, 31952
Site Ref # / Investigator 59446
Dammam
Site Ref # / Investigator 59424
Hofouf, 31982
Site Ref # / Investigator 59429
Hofouf, 31982
Site Ref # / Investigator 59395
Jeddah, 21411
Site Ref # / Investigator 59423
Jeddah, 21415
Site Ref # / Investigator 59404
Jeddah, 21432
Site Ref # / Investigator 59809
Jeddah, 21451
Site Ref # / Investigator 59396
Jeddah, 21452
Site Ref # / Investigator 59437
Jeddah, 21452
Site Ref # / Investigator 59441
Jeddah, 21452
Site Ref # / Investigator 59444
Jeddah, 21452
Site Ref # / Investigator 59385
Jeddah, 21461
Site Ref # / Investigator 59435
Jeddah, 21461
Site Ref # / Investigator 59807
Jeddah, 21461
Site Ref # / Investigator 59806
Jeddah, 21463
Site Ref # / Investigator 59390
Jeddah, 21473
Site Ref # / Investigator 59443
Jeddah, 21473
Site Ref # / Investigator 59397
Jeddah, 21524
Site Ref # / Investigator 59392
Jeddah
Site Ref # / Investigator 59805
Jubail, 31961
Site Ref # / Investigator 54491
Khamis Mushait
Site Ref # / Investigator 59402
Khamis Mushait
Site Ref # / Investigator 59804
Khamis Mushait
Site Ref # / Investigator 59387
Khobar, 31952
Site Ref # / Investigator 59426
Khobar, 31952
Site Ref # / Investigator 59438
Khobar, 31952
Site Ref # / Investigator 59453
Khobar, 31952
Site Ref # / Investigator 59383
Madinah
Site Ref # / Investigator 59384
Madinah
Site Ref # / Investigator 59428
Madinah
Site Ref # / Investigator 59439
Madinah
Site Ref # / Investigator 59808
Madinah
Site Ref # / Investigator 59386
Mecca
Site Ref # / Investigator 59393
Mecca
Site Ref # / Investigator 59403
Mecca
Site Ref # / Investigator 59448
Riyadh, 11393
Site Ref # / Investigator 59389
Riyadh, 11435
Site Ref # / Investigator 59432
Riyadh, 11435
Site Ref # / Investigator 59440
Riyadh, 11435
Site Ref # / Investigator 59400
Riyadh, 11471
Site Ref # / Investigator 59399
Riyadh, 11472
Site Ref # / Investigator 59422
Riyadh, 11521
Site Ref # / Investigator 59451
Riyadh, 11526
Site Ref # / Investigator 59425
Riyadh, 11534
Site Ref # / Investigator 59427
Riyadh, 11541
Site Ref # / Investigator 59430
Riyadh, 11545
Site Ref # / Investigator 59452
Riyadh, 11564
Site Ref # / Investigator 59449
Riyadh, 11586
Site Ref # / Investigator 59433
Riyadh, 11643
Site Ref # / Investigator 59442
Riyadh, 11643
Site Ref # / Investigator 59447
Riyadh, 11643
Site Ref # / Investigator 59401
Riyadh, 11652
Site Ref # / Investigator 59394
Riyadh, 11671
Site Ref # / Investigator 59436
Riyadh, 11671
Site Ref # / Investigator 59391
Tabuk
Site Ref # / Investigator 59407
Tabuk
Site Ref # / Investigator 59434
Tabuk
Site Ref # / Investigator 59445
Tabuk
Site Ref # / Investigator 59450
Tabuk
Site Ref # / Investigator 59431
Yanbu
Canada48 sites
Site Ref # / Investigator 59753
Barrie, Ontario, L4M 7G1
Site Ref # / Investigator 59777
Barrie, Ontario, L4M 7G1
Site Ref # / Investigator 59788
Beauceville, Quebec, G5X 1M4
Site Ref # / Investigator 59744
Burlington, Ontario, L7M 3Z5
Site Ref # / Investigator 59749
Burnaby, British Columbia, V5G 1T4
Site Ref # / Investigator 59765
Coquitlam, British Columbia, V3B 6S2
Site Ref # / Investigator 59766
Corunna, Ontario, N0N 1G0
Site Ref # / Investigator 59748
Dartmouth, Nova Scotia, B2Y 4P5
Site Ref # / Investigator 59780
Grand-Mère, Quebec, G9T 4T8
Site Ref # / Investigator 59773
Greater Sudbury, Ontario, P3B 1R6
Site Ref # / Investigator 59751
Greater Sudbury, Ontario, P3E 1H5
Site Ref # / Investigator 59755
Halifax, Nova Scotia, B3H 4M2
Site Ref # / Investigator 59752
Hamilton, Ontario, L8L 5G8
Site Ref # / Investigator 59764
Jarvis, Ontario, N0A 1J0
Site Ref # / Investigator 59742
Kamloops, British Columbia, V2C 5Y2
Site Ref # / Investigator 59775
Kelowna, British Columbia, V1X 7N6
Site Ref # / Investigator 59785
L'lle Perrot, Quebec, J7V 7X4
Site Ref # / Investigator 59774
Lindsay, Ontario, K9V 5N7
Site Ref # / Investigator 59768
London, Ontario, N5Y 5K7
Site Ref # / Investigator 59776
Markham, Ontario, L3R 4C3
Site Ref # / Investigator 59759
Mississauga, Ontario, L4X 2Z9
Site Ref # / Investigator 59761
Mississauga, Ontario, L4Y 2N7
Site Ref # / Investigator 59769
Montreal, Quebec, H2X 1N8
Site Ref # / Investigator 59746
Mount Royal, Quebec, H3P 1R6
Site Ref # / Investigator 54484
North York, Ontario, M2J 1V1
Site Ref # / Investigator 59760
Ottawa, Ontario, K2P 0W4
Site Ref # / Investigator 59757
Penticton, British Columbia, V2A 5C8
Site Ref # / Investigator 59747
Pickering, Ontario, L1V 6M4
Site Ref # / Investigator 59781
Québec, Quebec, G2E 2X1
Site Ref # / Investigator 59770
Saint-Ambroise, Quebec, G7P 2K6
Site Ref # / Investigator 59779
Saint-Ambroise, Quebec, G7P 2K6
Site Ref # / Investigator 59787
Saint-Hyacinthe, Quebec, J2S 4Z1
Site Ref # / Investigator 59782
Saint-Lambert-de-Lauzon, Quebec, G0S 2W0
Site Ref # / Investigator 59786
Saint-Nicolas, Quebec, G7A 3S8
Site Ref # / Investigator 59750
Sarnia, Ontario, N7T 4X3
Site Ref # / Investigator 59745
Scarborough Village, Ontario, M1T 3T6
Site Ref # / Investigator 59771
Sherbrooke, Ontario, J1E 2X4
Site Ref # / Investigator 59784
Ste-Marthe-sur-le-Lac, Quebec, J0N 1P0
Site Ref # / Investigator 59772
Stoney Creek, Ontario, L8G 3L2
Site Ref # / Investigator 59756
Toronto, Ontario, M4K 1N2
Site Ref # / Investigator 59758
Toronto, Ontario, M8X 2W2
Site Ref # / Investigator 59783
Trois-Rivières, Quebec, G8T 7A1
Site Ref # / Investigator 59754
Victoria, British Columbia, V9A 7N6
Site Ref # / Investigator 59778
Ville Mont-Royal, Quebec, H3P 2W3
Site Ref # / Investigator 59767
Welland, Ontario, L3B 3L2
Site Ref # / Investigator 59743
Windsor, Ontario, N8X 1T2
Site Ref # / Investigator 59763
Winnipeg, Manitoba, R2H 0R8
Site Ref # / Investigator 59762
Winnipeg, Manitoba, R3R 3C9
United Arab Emirates33 sites
Site Ref # / Investigator 59502
Abu Dhabi
Site Ref # / Investigator 59506
Abu Dhabi
Site Ref # / Investigator 59513
Abu Dhabi
Site Ref # / Investigator 59524
Abu Dhabi
Site Ref # / Investigator 59526
Abu Dhabi
Site Ref # / Investigator 59528
Abu Dhabi
Site Ref # / Investigator 59516
Ajman, 4184
Site Ref # / Investigator 59519
Ajman, 4184
Site Ref # / Investigator 59514
Alain
Site Ref # / Investigator 59532
Alain
Site Ref # / Investigator 59534
Dubai, 31500
Site Ref # / Investigator 59523
Dubai, 48577
Site Ref # / Investigator 59508
Dubai, 7832
Site Ref # / Investigator 54493
Dubai
Site Ref # / Investigator 59504
Dubai
Site Ref # / Investigator 59505
Dubai
Site Ref # / Investigator 59509
Dubai
Site Ref # / Investigator 59511
Dubai
Site Ref # / Investigator 59517
Dubai
Site Ref # / Investigator 59518
Dubai
Site Ref # / Investigator 59521
Dubai
Site Ref # / Investigator 59525
Dubai
Site Ref # / Investigator 59529
Dubai
Site Ref # / Investigator 59531
Dubai
Site Ref # / Investigator 59533
Dubai
Site Ref # / Investigator 59510
Ras al-Khaimah, 5442
Site Ref # / Investigator 59515
Ras al-Khaimah, 5442
Site Ref # / Investigator 59522
Sharjah city, 20543
Site Ref # / Investigator 59530
Sharjah city, 2797
Site Ref # / Investigator 59507
Sharjah city, 3499
Site Ref # / Investigator 59512
Sharjah city, 3499
Site Ref # / Investigator 59535
Sharjah city, 3499
Site Ref # / Investigator 59527
Sharjah city, 457
Germany32 sites
Site Ref # / Investigator 59864
Bad Kreuznach, 5543
Site Ref # / Investigator 59867
Bad Schönborn, 76669
Site Ref # / Investigator 59889
Berlin, 10627
Site Ref # / Investigator 59884
Cologne, 50737
Site Ref # / Investigator 59879
Duisburg, 47179
Site Ref # / Investigator 59868
Erkrath, 40699
Site Ref # / Investigator 59862
Erlangen, 82467
Site Ref # / Investigator 59872
Essen, 45329
Site Ref # / Investigator 59886
Essen, 45329
Site Ref # / Investigator 59888
Frankfurt, 60313
Site Ref # / Investigator 59881
Freiburg im Breisgau, 79106
Site Ref # / Investigator 59861
Garmisch-Patenkirchen, 82467
Site Ref # / Investigator 59882
Gelsenkirchen, 45894
Site Ref # / Investigator 59876
Giessen, 35385
Site Ref # / Investigator 59883
Halle, 6120
Site Ref # / Investigator 59880
Hamburg, 20255
Site Ref # / Investigator 59870
Kamp-Lintfort, 47475
Site Ref # / Investigator 59860
Landstuhl, 66849
Site Ref # / Investigator 59877
Marburg, 35039
Site Ref # / Investigator 59866
München, 80331
Site Ref # / Investigator 59863
Münster, 48149
Site Ref # / Investigator 59874
Neuss, 41460
Site Ref # / Investigator 59890
Nieder-Olm, 55268
Site Ref # / Investigator 59873
Nienburg, 31582
Site Ref # / Investigator 59887
Osnabrück, 49080
Site Ref # / Investigator 59878
Paderborn, 33098
Site Ref # / Investigator 59875
Plön, 24306
Site Ref # / Investigator 59871
Saarlouis, 66740
Site Ref # / Investigator 59885
Schwelm, 58332
Site Ref # / Investigator 59869
Seligenstadt, 63500
Site Ref # / Investigator 54486
Warendorf, 48231
Site Ref # / Investigator 59865
Weiden, 92637
Romania29 sites
Site Ref # / Investigator 59488
Arad, 310158
Site Ref # / Investigator 59483
Brasov, 500365
Site Ref # / Investigator 59461
Bucharest, 010825
Site Ref # / Investigator 59460
Bucharest, 10825
Site Ref # / Investigator 59455
Bucharest, 11863
Site Ref # / Investigator 59459
Bucharest, 11863
Site Ref # / Investigator 59454
Bucharest, 20054
Site Ref # / Investigator 54489
Bucharest, 21336
Site Ref # / Investigator 59456
Bucharest, 41345
Site Ref # / Investigator 59458
Bucharest, 50042
Site Ref # / Investigator 59457
Bucharest, 50659
Site Ref # / Investigator 59462
Bucharest, 50659
Site Ref # / Investigator 59465
Cluj-Napoca, 400001
Site Ref # / Investigator 59473
Cluj-Napoca, 400006
Site Ref # / Investigator 59464
Cluj-Napoca, 4000349
Site Ref # / Investigator 59463
Cluj-Napoca, 400046
Site Ref # / Investigator 59466
Cluj-Napoca, 400349
Site Ref # / Investigator 59475
Cluj-Napoca, 400349
Site Ref # / Investigator 59479
Iași, 700056
Site Ref # / Investigator 59476
Iași, 700111
Site Ref # / Investigator 59477
Iași, 700111
Site Ref # / Investigator 59478
Iași, 700111
Site Ref # / Investigator 59480
Iași, 700483
Site Ref # / Investigator 59484
Sibiu, 550245
Site Ref # / Investigator 59482
Târgu Mureş, 540103
Site Ref # / Investigator 59481
Târgu Mureş, 540139
Site Ref # / Investigator 59485
Timișoara, 300011
Site Ref # / Investigator 59487
Timișoara, 300386
Site Ref # / Investigator 59486
Timișoara, 300736
Croatia28 sites
Site Ref # / Investigator 59628
Dubrovnik, 20000
Site Ref # / Investigator 59627
Karlovac, 47000
Site Ref # / Investigator 59540
Osijek, 31000
Site Ref # / Investigator 59626
Pula, 52100
Site Ref # / Investigator 59554
Rijeka, 51000
Site Ref # / Investigator 59622
Rijeka, 51000
Site Ref # / Investigator 59623
Rijeka, 51000
Site Ref # / Investigator 59624
Rijeka, 51000
Site Ref # / Investigator 59629
Rijeka, 51000
Site Ref # / Investigator 59550
Split, 21000
Site Ref # / Investigator 59551
Split, 21000
Site Ref # / Investigator 59552
Split, 21000
Site Ref # / Investigator 59553
Split, 21000
Site Ref # / Investigator 59625
Split, 21000
Site Ref # / Investigator 59536
Zagreb, 10000
Site Ref # / Investigator 59537
Zagreb, 10000
Site Ref # / Investigator 59538
Zagreb, 10000
Site Ref # / Investigator 59539
Zagreb, 10000
Site Ref # / Investigator 59541
Zagreb, 10000
Site Ref # / Investigator 59542
Zagreb, 10000
Site Ref # / Investigator 59543
Zagreb, 10000
Site Ref # / Investigator 59544
Zagreb, 10000
Site Ref # / Investigator 59545
Zagreb, 10000
Site Ref # / Investigator 59546
Zagreb, 10000
Site Ref # / Investigator 59547
Zagreb, 10000
Site Ref # / Investigator 59548
Zagreb, 10000
Site Ref # / Investigator 59549
Zagreb, 10000
Site Ref # / Investigator 54485
Zagreb, 20000
Slovenia16 sites
Site Ref # / Investigator 59800
Celje, SL 3000
Site Ref # / Investigator 59802
Celje, SL 3000
Site Ref # / Investigator 59798
Celje, SL3000
Site Ref # / Investigator 54492
Ljubljana, SL 1000
Site Ref # / Investigator 59791
Ljubljana, SL 1000
Site Ref # / Investigator 59792
Ljubljana, SL 1000
Site Ref # / Investigator 59793
Ljubljana, SL 1000
Site Ref # / Investigator 59794
Ljubljana, SL 1000
Site Ref # / Investigator 59797
Ljubljana, SL 1000
Site Ref # / Investigator 59799
Ljubljana, SL 1000
Site Ref # / Investigator 59789
Maribor, SL 2000
Site Ref # / Investigator 59790
Maribor, SL 2000
Site Ref # / Investigator 59795
Maribor, SL 2000
Site Ref # / Investigator 59796
Maribor, SL 2000
Site Ref # / Investigator 59801
Maribor, SL 2000
Site Ref # / Investigator 59803
Novo Mesto, SL 8000
Kuwait6 sites
Site Ref # / Investigator 59631
Ad Dasmah, 35151
Site Ref # / Investigator 54487
Ahmandi, 61002
Site Ref # / Investigator 59633
Al Ahmadi, 61002
Site Ref # / Investigator 59634
As Sālimīyah, 22077
Site Ref # / Investigator 59630
Bayān, 43755
Site Ref # / Investigator 59632
Bayān, 43755
About this study
Official title: Energy, Sexual Desire and Body PropoRtions wIth AndroGel®, Testosterone 1% Gel Therapy (ESPRIT) in Hypogonadal Men
Observational study with AndroGel®, Testosterone 1% gel therapy (ESPRIT) in hypogonadal men in the community over 6 months.
Read the detailed description
The objective of this study was to evaluate the efficacy and safety of AndroGel (testosterone gel) 1% following administration in community dwelling men with hypogonadism. The percent change from baseline to Month 6 in aging male symptom (AMS) assessment was the primary endpoint. Secondary endpoints were changes from baseline to Month 6 in International Index of Erectile Dysfunction (IIEF), Multidimensional Fatigue Inventory (MFI), and body mass index (BMI) assessments.
- Conditions
- Hypogonadism
- Being tested
- AndroGel (testosterone gel) 1%
- Keywords
- Male hypogonadism
- Medical subject headings
- Hypogonadism, Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AndroGel (testosterone gel) 1%Drug
Also called Topical AndroGel, 1% AndroGel, AndroGel®
AndroGel is topical testosterone gel 1% and is prescribed for once daily use.
| Study group | Role | What they receive |
|---|---|---|
| AndroGel (testosterone gel )1% | AndroGel is topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. Receives: Drug: AndroGel (testosterone gel) 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score
The Aging Male Symptoms (AMS) test is self-administered and designed to assess symptoms of aging with a rating from none (0) to extremely severe (5) for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total scores range from 17 (minimum) to 85 (maximum). The AMS total score was reported at baseline and at Month 6 and represented the sum of all the items. The percent change from baseline was calculated as the [(AMS value at Month 6 - AMS value at baseline)/baseline value] x 100.
Measured: Baseline to Month 6
Secondary outcomes (3)
Percent Change From Baseline to Month 6 in the International Index of Erectile Function (IIEF) Total Score
The International Index of Erectile Function (IIEF) test is a validated 15 question assessment designed to measure changes in erectile function (6 items), orgasmic function (2 items), sexual desire (2 items), intercourse satisfaction (3 items), and overall satisfaction (2 items). The scores ranged from 0 to 5 on each item with a lower score indicating greater dysfunction. A total IIEF score of 0 (minimum) to 75 (maximum) was possible and represented the sum of all the items at baseline and Month 6. The percent change = [(IIEF value at Month 6-IIEF baseline value)/IIEF baseline value]x 100.
Measured: Baseline to Month 6
Percent Change From Baseline to Month 6 in the Multidimensional Fatigue Inventory (MFI) Total Score
The MFI is a 20-item self-reported instrument designed to measure fatigue. Five scales measure different modes of fatigue: general fatigue (4 items), physical fatigue (4 items), mental fatigue (4 items), reduced motivation (4 items), and reduced activity items (4 items). The scores for each item range from 1 to 5. Each subscale includes 4 items with 5-point Likert scales and subscale scores range from 4 to 20 with a higher score indicating greater fatigue. The percent change=[(MFI value at Month 6-MFI value at baseline)/MFI baseline value] X 100.
Measured: Baseline to Month 6
Percent Change From Baseline to Month 6 in Body Mass Index (BMI)
The BMI was measured in kg/m^2 and was reported at baseline and at the Month 6. BMI = weight (kg)/[(height (m) x height (m)] and was measured to 1 decimal point precision.
Measured: Baseline to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startDec 2007
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,053 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fovea
- Responsible party
- Sponsor
- Investigators
- Michael Miller, PharmD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143818
- Sponsor's protocol ID
- S176.4.103
- Status last verified
- Oct 2011
- First submitted
- 9 Jun 2010
- Last updated
- 17 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy, Sexual Desire and Body PropoRtions wIth AndroGel®, Testosterone 1% Gel Therapy (ESPRIT) in Hypogonadal Men
- ClinicalTrials.gov ID
- NCT01143818
- Acronym / sponsor ID
- S176.4.103
- Conditions
- Hypogonadism
- Keywords
- Male hypogonadism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,053 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Fovea
- Study start
- Dec 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 14 Jun 2010 (estimated)
- Results
- Posted 26 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study with AndroGel®, Testosterone 1% gel therapy (ESPRIT) in hypogonadal men in the community over 6 months.
Detailed description
The objective of this study was to evaluate the efficacy and safety of AndroGel (testosterone gel) 1% following administration in community dwelling men with hypogonadism. The percent change from baseline to Month 6 in aging male symptom (AMS) assessment was the primary endpoint. Secondary endpoints were changes from baseline to Month 6 in International Index of Erectile Dysfunction (IIEF), Multidimensional Fatigue Inventory (MFI), and body mass index (BMI) assessments.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AndroGel (testosterone gel )1% | – | Drug: AndroGel (testosterone gel) 1%AndroGel is topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community
Key inclusion criteria (4 listed)
- Male patients >= 18 years of age
- Hypogonadism not previously treated with testosterone
- Testosterone deficiency confirmed clinically and biochemically
- Being prescribed AndroGel® 1% in accordance with the local summary of product characteristics
Key exclusion criteria (2 listed)
- According to the contra-indications,
- Unwilling or unable to sign informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AndroGel (testosterone gel) 1%Also: Topical AndroGel, 1% AndroGel, AndroGel®AndroGel is topical testosterone gel 1% and is prescribed for once daily use. | Drug | AndroGel (testosterone gel )1% |
Primary outcome
Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score
Time frame: Baseline to Month 6
The Aging Male Symptoms (AMS) test is self-administered and designed to assess symptoms of aging with a rating from none (0) to extremely severe (5) for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total scores range from 17 (minimum) to 85 (maximum). The AMS total score was reported at baseline and at Month 6 and represented the sum of all the items. The percent change from baseline was calculated as the [(AMS value at Month 6 - AMS value at baseline)/baseline value] x 100.
3 secondary outcomes
Percent Change From Baseline to Month 6 in the International Index of Erectile Function (IIEF) Total Score
Time frame: Baseline to Month 6
Percent Change From Baseline to Month 6 in the Multidimensional Fatigue Inventory (MFI) Total Score
Time frame: Baseline to Month 6
Percent Change From Baseline to Month 6 in Body Mass Index (BMI)
Time frame: Baseline to Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Miller, PharmD study director
Abbott
331 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypogonadism, run by Abbott at 331 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 331 sites in Russia, Saudi Arabia, Canada, United Arab Emirates, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score (time frame: Baseline to Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2011.