Hypogonadism Clinical Trial
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.
| Status | Completed |
| Enrollment | 1053 |
| Est. completion date | August 2010 |
| Est. primary completion date | August 2010 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria 1. Male patients >= 18 years of age 2. Hypogonadism not previously treated with testosterone 3. Testosterone deficiency confirmed clinically and biochemically 4. Being prescribed AndroGel® 1% in accordance with the local summary of product characteristics Exclusion Criteria 1. According to the contra-indications, 2. Unwilling or unable to sign informed consent form |
Observational Model: Ecologic or Community, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Canada | Site Ref # / Investigator 59753 | Barrie | Ontario |
| Canada | Site Ref # / Investigator 59777 | Barrie | Ontario |
| Canada | Site Ref # / Investigator 59788 | Beauceville | Quebec |
| Canada | Site Ref # / Investigator 59744 | Burlington | Ontario |
| Canada | Site Ref # / Investigator 59749 | Burnaby | British Columbia |
| Canada | Site Ref # / Investigator 59765 | Coquitlam | British Columbia |
| Canada | Site Ref # / Investigator 59766 | Corunna | Ontario |
| Canada | Site Ref # / Investigator 59748 | Dartmouth | Nova Scotia |
| Canada | Site Ref # / Investigator 59780 | Grand-Mere | Quebec |
| Canada | Site Ref # / Investigator 59755 | Halifax | Nova Scotia |
| Canada | Site Ref # / Investigator 59752 | Hamilton | Ontario |
| Canada | Site Ref # / Investigator 59764 | Jarvis | Ontario |
| Canada | Site Ref # / Investigator 59742 | Kamloops | British Columbia |
| Canada | Site Ref # / Investigator 59775 | Kelowna | British Columbia |
| Canada | Site Ref # / Investigator 59785 | L'lle Perrot | Quebec |
| Canada | Site Ref # / Investigator 59774 | Lindsay | Ontario |
| Canada | Site Ref # / Investigator 59768 | London | Ontario |
| Canada | Site Ref # / Investigator 59776 | Markham | Ontario |
| Canada | Site Ref # / Investigator 59759 | Mississauga | Ontario |
| Canada | Site Ref # / Investigator 59761 | Mississauga | Ontario |
| Canada | Site Ref # / Investigator 59746 | Mont-Royal | Quebec |
| Canada | Site Ref # / Investigator 59769 | Montreal | Quebec |
| Canada | Site Ref # / Investigator 54484 | North York | Ontario |
| Canada | Site Ref # / Investigator 59760 | Ottawa | Ontario |
| Canada | Site Ref # / Investigator 59757 | Penticton | British Columbia |
| Canada | Site Ref # / Investigator 59747 | Pickering | Ontario |
| Canada | Site Ref # / Investigator 59781 | Quebec | |
| Canada | Site Ref # / Investigator 59787 | Saint-Hyacinthe | Quebec |
| Canada | Site Ref # / Investigator 59782 | Saint-Lambert-de-Lauzon | Quebec |
| Canada | Site Ref # / Investigator 59786 | Saint-Nicolas | Quebec |
| Canada | Site Ref # / Investigator 59750 | Sarnia | Ontario |
| Canada | Site Ref # / Investigator 59745 | Scarborough | Ontario |
| Canada | Site Ref # / Investigator 59771 | Sherbrooke | Ontario |
| Canada | Site Ref # / Investigator 59770 | St. Ambroise | Quebec |
| Canada | Site Ref # / Investigator 59779 | St. Ambroise | Quebec |
| Canada | Site Ref # / Investigator 59784 | Ste-Marthe-sur-le-Lac | Quebec |
| Canada | Site Ref # / Investigator 59772 | Stoney Creek | Ontario |
| Canada | Site Ref # / Investigator 59751 | Sudbury | Ontario |
| Canada | Site Ref # / Investigator 59773 | Sudbury | Ontario |
| Canada | Site Ref # / Investigator 59756 | Toronto | Ontario |
| Canada | Site Ref # / Investigator 59758 | Toronto | Ontario |
| Canada | Site Ref # / Investigator 59783 | Trois-Rivieres | Quebec |
| Canada | Site Ref # / Investigator 59754 | Victoria | British Columbia |
| Canada | Site Ref # / Investigator 59778 | Ville Mont-Royal | Quebec |
| Canada | Site Ref # / Investigator 59767 | Welland | Ontario |
| Canada | Site Ref # / Investigator 59743 | Windsor | Ontario |
| Canada | Site Ref # / Investigator 59762 | Winnipeg | Manitoba |
| Canada | Site Ref # / Investigator 59763 | Winnipeg | Manitoba |
| Croatia | Site Ref # / Investigator 59628 | Dubrovnik | |
| Croatia | Site Ref # / Investigator 59627 | Karlovac | |
| Croatia | Site Ref # / Investigator 59540 | Osijek | |
| Croatia | Site Ref # / Investigator 59626 | Pula | |
| Croatia | Site Ref # / Investigator 59554 | Rijeka | |
| Croatia | Site Ref # / Investigator 59622 | Rijeka | |
| Croatia | Site Ref # / Investigator 59623 | Rijeka | |
| Croatia | Site Ref # / Investigator 59624 | Rijeka | |
| Croatia | Site Ref # / Investigator 59629 | Rijeka | |
| Croatia | Site Ref # / Investigator 59550 | Split | |
| Croatia | Site Ref # / Investigator 59551 | Split | |
| Croatia | Site Ref # / Investigator 59552 | Split | |
| Croatia | Site Ref # / Investigator 59553 | Split | |
| Croatia | Site Ref # / Investigator 59625 | Split | |
| Croatia | Site Ref # / Investigator 54485 | Zagreb | |
| Croatia | Site Ref # / Investigator 59536 | Zagreb | |
| Croatia | Site Ref # / Investigator 59537 | Zagreb | |
| Croatia | Site Ref # / Investigator 59538 | Zagreb | |
| Croatia | Site Ref # / Investigator 59539 | Zagreb | |
| Croatia | Site Ref # / Investigator 59541 | Zagreb | |
| Croatia | Site Ref # / Investigator 59542 | Zagreb | |
| Croatia | Site Ref # / Investigator 59543 | Zagreb | |
| Croatia | Site Ref # / Investigator 59544 | Zagreb | |
| Croatia | Site Ref # / Investigator 59545 | Zagreb | |
| Croatia | Site Ref # / Investigator 59546 | Zagreb | |
| Croatia | Site Ref # / Investigator 59547 | Zagreb | |
| Croatia | Site Ref # / Investigator 59548 | Zagreb | |
| Croatia | Site Ref # / Investigator 59549 | Zagreb | |
| Germany | Site Ref # / Investigator 59864 | Bad Kreuznach | |
| Germany | Site Ref # / Investigator 59867 | Bad Schönborn | |
| Germany | Site Ref # / Investigator 59889 | Berlin | |
| Germany | Site Ref # / Investigator 59879 | Duisburg | |
| Germany | Site Ref # / Investigator 59868 | Erkrath | |
| Germany | Site Ref # / Investigator 59862 | Erlangen | |
| Germany | Site Ref # / Investigator 59872 | Essen | |
| Germany | Site Ref # / Investigator 59886 | Essen | |
| Germany | Site Ref # / Investigator 59888 | Frankfurt | |
| Germany | Site Ref # / Investigator 59881 | Freiburg | |
| Germany | Site Ref # / Investigator 59861 | Garmisch-Patenkirchen | |
| Germany | Site Ref # / Investigator 59882 | Gelsenkirchen | |
| Germany | Site Ref # / Investigator 59876 | Giessen | |
| Germany | Site Ref # / Investigator 59883 | Halle | |
| Germany | Site Ref # / Investigator 59880 | Hamburg | |
| Germany | Site Ref # / Investigator 59870 | Kamp-Lintfort | |
| Germany | Site Ref # / Investigator 59884 | Koln | |
| Germany | Site Ref # / Investigator 59860 | Landstuhl | |
| Germany | Site Ref # / Investigator 59877 | Marburg | |
| Germany | Site Ref # / Investigator 59863 | Muenster | |
| Germany | Site Ref # / Investigator 59866 | München | |
| Germany | Site Ref # / Investigator 59874 | Neuss | |
| Germany | Site Ref # / Investigator 59890 | Nieder-Olm | |
| Germany | Site Ref # / Investigator 59873 | Nienburg | |
| Germany | Site Ref # / Investigator 59887 | Osnabrueck | |
| Germany | Site Ref # / Investigator 59878 | Paderborn | |
| Germany | Site Ref # / Investigator 59875 | Plon | |
| Germany | Site Ref # / Investigator 59871 | Saarlouis | |
| Germany | Site Ref # / Investigator 59885 | Schwelm | |
| Germany | Site Ref # / Investigator 59869 | Seligenstadt | |
| Germany | Site Ref # / Investigator 54486 | Warendorf | |
| Germany | Site Ref # / Investigator 59865 | Weiden | |
| Kuwait | Site Ref # / Investigator 59633 | Ahmadi | |
| Kuwait | Site Ref # / Investigator 54487 | Ahmandi | |
| Kuwait | Site Ref # / Investigator 59630 | Bayan | |
| Kuwait | Site Ref # / Investigator 59632 | Bayan | |
| Kuwait | Site Ref # / Investigator 59631 | Dasma | |
| Kuwait | Site Ref # / Investigator 59634 | Salmiyah | |
| Romania | Site Ref # / Investigator 59488 | Arad | |
| Romania | Site Ref # / Investigator 59483 | Brasov | |
| Romania | Site Ref # / Investigator 59458 | Bucharest | |
| Romania | Site Ref # / Investigator 59461 | Bucharest | |
| Romania | Site Ref # / Investigator 54489 | Bucuresti | |
| Romania | Site Ref # / Investigator 59454 | Bucuresti | |
| Romania | Site Ref # / Investigator 59455 | Bucuresti | |
| Romania | Site Ref # / Investigator 59456 | Bucuresti | |
| Romania | Site Ref # / Investigator 59457 | Bucuresti | |
| Romania | Site Ref # / Investigator 59459 | Bucuresti | |
| Romania | Site Ref # / Investigator 59460 | Bucuresti | |
| Romania | Site Ref # / Investigator 59462 | Bucuresti | |
| Romania | Site Ref # / Investigator 59463 | Cluj-Napoca | |
| Romania | Site Ref # / Investigator 59464 | Cluj-Napoca | |
| Romania | Site Ref # / Investigator 59465 | Cluj-Napoca | |
| Romania | Site Ref # / Investigator 59466 | Cluj-Napoca | |
| Romania | Site Ref # / Investigator 59473 | Cluj-Napoca | |
| Romania | Site Ref # / Investigator 59475 | Cluj-Napoca | |
| Romania | Site Ref # / Investigator 59476 | Iasi | |
| Romania | Site Ref # / Investigator 59477 | Iasi | |
| Romania | Site Ref # / Investigator 59478 | Iasi | |
| Romania | Site Ref # / Investigator 59479 | Iasi | |
| Romania | Site Ref # / Investigator 59480 | Iasi | |
| Romania | Site Ref # / Investigator 59484 | Sibiu | |
| Romania | Site Ref # / Investigator 59481 | Targu-Mures | |
| Romania | Site Ref # / Investigator 59482 | Targu-Mures | |
| Romania | Site Ref # / Investigator 59485 | Timisoara | |
| Romania | Site Ref # / Investigator 59486 | Timisoara | |
| Romania | Site Ref # / Investigator 59487 | Timisoara | |
| Russian Federation | Site Ref # / Investigator 59644 | Ekaterinburg | |
| Russian Federation | Site Ref # / Investigator 59647 | Ekaterinburg | |
| Russian Federation | Site Ref # / Investigator 59898 | Ekaterinburg | |
| Russian Federation | Site Ref # / Investigator 59904 | Ekaterinburg | |
| Russian Federation | Site Ref # / Investigator 59695 | Kazan | |
| Russian Federation | Site Ref # / Investigator 59891 | Kazan | |
| Russian Federation | Site Ref # / Investigator 59643 | Kemerovo | |
| Russian Federation | Site Ref # / Investigator 59697 | Kemerovo | |
| Russian Federation | Site Ref # / Investigator 59654 | Khabarovsk | |
| Russian Federation | Site Ref # / Investigator 59893 | Khabarovsk | |
| Russian Federation | Site Ref # / Investigator 59897 | Krasnodar | |
| Russian Federation | Site Ref # / Investigator 59900 | Krasnodar | |
| Russian Federation | Site Ref # / Investigator 59675 | Krasnoyarsk | |
| Russian Federation | Site Ref # / Investigator 59903 | Krasnoyarsk | |
| Russian Federation | Site Ref # / Investigator 59646 | Moscow | |
| Russian Federation | Site Ref # / Investigator 59648 | Moscow | |
| Russian Federation | Site Ref # / Investigator 59649 | Moscow | |
| Russian Federation | Site Ref # / Investigator 59650 | Moscow | |
| Russian Federation | Site Ref # / Investigator 59651 | Moscow | |
| Russian Federation | Site Ref # / Investigator 59662 | Moscow | |
| Russian Federation | Site Ref # / Investigator 59665 | Moscow | |
| Russian Federation | Site Ref # / Investigator 59678 | Moscow | |
| Russian Federation | Site Ref # / Investigator 59688 | Moscow | |
| Russian Federation | Site Ref # / Investigator 59689 | Moscow | |
| Russian Federation | Site Ref # / Investigator 59698 | Moscow | |
| Russian Federation | Site Ref # / Investigator 59896 | Moscow | |
| Russian Federation | Site Ref # / Investigator 59902 | Moscow | |
| Russian Federation | Site Ref # / Investigator 59638 | N. Novgorod | |
| Russian Federation | Site Ref # / Investigator 59668 | N. Novgorod | |
| Russian Federation | Site Ref # / Investigator 59677 | N. Novgorod | |
| Russian Federation | Site Ref # / Investigator 59645 | Naberezhnye Chelny | |
| Russian Federation | Site Ref # / Investigator 59656 | Novosibirsk | |
| Russian Federation | Site Ref # / Investigator 59693 | Novosibirsk | |
| Russian Federation | Site Ref # / Investigator 59694 | Novosibirsk | |
| Russian Federation | Site Ref # / Investigator 59895 | Novosibirsk | |
| Russian Federation | Site Ref # / Investigator 59637 | Penza | |
| Russian Federation | Site Ref # / Investigator 59641 | Penza | |
| Russian Federation | Site Ref # / Investigator 59657 | Penza | |
| Russian Federation | Site Ref # / Investigator 59636 | Rostov-On-Don | |
| Russian Federation | Site Ref # / Investigator 59655 | Rostov-On-Don | |
| Russian Federation | Site Ref # / Investigator 59667 | Rostov-On-Don | |
| Russian Federation | Site Ref # / Investigator 59699 | Rostov-On-Don | |
| Russian Federation | Site Ref # / Investigator 54490 | Saint-Petersburg | |
| Russian Federation | Site Ref # / Investigator 59640 | Saint-Petersburg | |
| Russian Federation | Site Ref # / Investigator 59642 | Saint-Petersburg | |
| Russian Federation | Site Ref # / Investigator 59658 | Saint-Petersburg | |
| Russian Federation | Site Ref # / Investigator 59676 | Saint-Petersburg | |
| Russian Federation | Site Ref # / Investigator 59679 | Saint-Petersburg | |
| Russian Federation | Site Ref # / Investigator 59691 | Saint-Petersburg | |
| Russian Federation | Site Ref # / Investigator 59700 | Saint-Petersburg | |
| Russian Federation | Site Ref # / Investigator 59672 | Samara | |
| Russian Federation | Site Ref # / Investigator 59661 | Saratov | |
| Russian Federation | Site Ref # / Investigator 59666 | Saratov | |
| Russian Federation | Site Ref # / Investigator 59653 | Togliatti | |
| Russian Federation | Site Ref # / Investigator 59663 | Togliatti | |
| Russian Federation | Site Ref # / Investigator 59905 | Togliatti | |
| Russian Federation | Site Ref # / Investigator 59673 | Tomsk | |
| Russian Federation | Site Ref # / Investigator 59690 | Tomsk | |
| Russian Federation | Site Ref # / Investigator 59692 | Tomsk | |
| Russian Federation | Site Ref # / Investigator 59652 | UFA | |
| Russian Federation | Site Ref # / Investigator 59659 | UFA | |
| Russian Federation | Site Ref # / Investigator 59669 | UFA | |
| Russian Federation | Site Ref # / Investigator 59670 | UFA | |
| Russian Federation | Site Ref # / Investigator 59639 | Vladivostok | |
| Russian Federation | Site Ref # / Investigator 59660 | Vladivostok | |
| Russian Federation | Site Ref # / Investigator 59901 | Vladivostok | |
| Russian Federation | Site Ref # / Investigator 59635 | Volgograd | |
| Russian Federation | Site Ref # / Investigator 59892 | Volgograd | |
| Russian Federation | Site Ref # / Investigator 59671 | Voronezh | |
| Russian Federation | Site Ref # / Investigator 59696 | Voronezh | |
| Russian Federation | Site Ref # / Investigator 59894 | Voronezh | |
| Russian Federation | Site Ref # / Investigator 59906 | Voronezh | |
| Russian Federation | Site Ref # / Investigator 59664 | Yaroslavl | |
| Russian Federation | Site Ref # / Investigator 59674 | Yaroslavl | |
| Russian Federation | Site Ref # / Investigator 59899 | Yaroslavl | |
| Saudi Arabia | Site Ref # / Investigator 59398 | Abha | |
| Saudi Arabia | Site Ref # / Investigator 59388 | Dammam | |
| Saudi Arabia | Site Ref # / Investigator 59405 | Dammam | |
| Saudi Arabia | Site Ref # / Investigator 59406 | Dammam | |
| Saudi Arabia | Site Ref # / Investigator 59446 | Dammam | |
| Saudi Arabia | Site Ref # / Investigator 59424 | Hofouf | |
| Saudi Arabia | Site Ref # / Investigator 59429 | Hofouf | |
| Saudi Arabia | Site Ref # / Investigator 59385 | Jeddah | |
| Saudi Arabia | Site Ref # / Investigator 59390 | Jeddah | |
| Saudi Arabia | Site Ref # / Investigator 59392 | Jeddah | |
| Saudi Arabia | Site Ref # / Investigator 59395 | Jeddah | |
| Saudi Arabia | Site Ref # / Investigator 59396 | Jeddah | |
| Saudi Arabia | Site Ref # / Investigator 59397 | Jeddah | |
| Saudi Arabia | Site Ref # / Investigator 59404 | Jeddah | |
| Saudi Arabia | Site Ref # / Investigator 59423 | Jeddah | |
| Saudi Arabia | Site Ref # / Investigator 59435 | Jeddah | |
| Saudi Arabia | Site Ref # / Investigator 59437 | Jeddah | |
| Saudi Arabia | Site Ref # / Investigator 59441 | Jeddah | |
| Saudi Arabia | Site Ref # / Investigator 59443 | Jeddah | |
| Saudi Arabia | Site Ref # / Investigator 59444 | Jeddah | |
| Saudi Arabia | Site Ref # / Investigator 59806 | Jeddah | |
| Saudi Arabia | Site Ref # / Investigator 59807 | Jeddah | |
| Saudi Arabia | Site Ref # / Investigator 59809 | Jeddah | |
| Saudi Arabia | Site Ref # / Investigator 59805 | Jubail | |
| Saudi Arabia | Site Ref # / Investigator 54491 | Khamis Mushait | |
| Saudi Arabia | Site Ref # / Investigator 59402 | Khamis Mushait | |
| Saudi Arabia | Site Ref # / Investigator 59804 | Khamis Mushait | |
| Saudi Arabia | Site Ref # / Investigator 59387 | Khobar | |
| Saudi Arabia | Site Ref # / Investigator 59426 | Khobar | |
| Saudi Arabia | Site Ref # / Investigator 59438 | Khobar | |
| Saudi Arabia | Site Ref # / Investigator 59453 | Khobar | |
| Saudi Arabia | Site Ref # / Investigator 59383 | Madina | |
| Saudi Arabia | Site Ref # / Investigator 59384 | Madina | |
| Saudi Arabia | Site Ref # / Investigator 59428 | Madina | |
| Saudi Arabia | Site Ref # / Investigator 59439 | Madina | |
| Saudi Arabia | Site Ref # / Investigator 59808 | Madina | |
| Saudi Arabia | Site Ref # / Investigator 59386 | Makka | |
| Saudi Arabia | Site Ref # / Investigator 59393 | Makka | |
| Saudi Arabia | Site Ref # / Investigator 59403 | Makka | |
| Saudi Arabia | Site Ref # / Investigator 59389 | Riyadh | |
| Saudi Arabia | Site Ref # / Investigator 59394 | Riyadh | |
| Saudi Arabia | Site Ref # / Investigator 59399 | Riyadh | |
| Saudi Arabia | Site Ref # / Investigator 59400 | Riyadh | |
| Saudi Arabia | Site Ref # / Investigator 59401 | Riyadh | |
| Saudi Arabia | Site Ref # / Investigator 59422 | Riyadh | |
| Saudi Arabia | Site Ref # / Investigator 59425 | Riyadh | |
| Saudi Arabia | Site Ref # / Investigator 59427 | Riyadh | |
| Saudi Arabia | Site Ref # / Investigator 59430 | Riyadh | |
| Saudi Arabia | Site Ref # / Investigator 59432 | Riyadh | |
| Saudi Arabia | Site Ref # / Investigator 59433 | Riyadh | |
| Saudi Arabia | Site Ref # / Investigator 59436 | Riyadh | |
| Saudi Arabia | Site Ref # / Investigator 59440 | Riyadh | |
| Saudi Arabia | Site Ref # / Investigator 59442 | Riyadh | |
| Saudi Arabia | Site Ref # / Investigator 59447 | Riyadh | |
| Saudi Arabia | Site Ref # / Investigator 59448 | Riyadh | |
| Saudi Arabia | Site Ref # / Investigator 59449 | Riyadh | |
| Saudi Arabia | Site Ref # / Investigator 59451 | Riyadh | |
| Saudi Arabia | Site Ref # / Investigator 59452 | Riyadh | |
| Saudi Arabia | Site Ref # / Investigator 59391 | Tabuk | |
| Saudi Arabia | Site Ref # / Investigator 59407 | Tabuk | |
| Saudi Arabia | Site Ref # / Investigator 59434 | Tabuk | |
| Saudi Arabia | Site Ref # / Investigator 59445 | Tabuk | |
| Saudi Arabia | Site Ref # / Investigator 59450 | Tabuk | |
| Saudi Arabia | Site Ref # / Investigator 59431 | Yanbu | |
| Slovenia | Site Ref # / Investigator 59798 | Celje | |
| Slovenia | Site Ref # / Investigator 59800 | Celje | |
| Slovenia | Site Ref # / Investigator 59802 | Celje | |
| Slovenia | Site Ref # / Investigator 54492 | Ljubljana | |
| Slovenia | Site Ref # / Investigator 59791 | Ljubljana | |
| Slovenia | Site Ref # / Investigator 59792 | Ljubljana | |
| Slovenia | Site Ref # / Investigator 59793 | Ljubljana | |
| Slovenia | Site Ref # / Investigator 59794 | Ljubljana | |
| Slovenia | Site Ref # / Investigator 59797 | Ljubljana | |
| Slovenia | Site Ref # / Investigator 59799 | Ljubljana | |
| Slovenia | Site Ref # / Investigator 59789 | Maribor | |
| Slovenia | Site Ref # / Investigator 59790 | Maribor | |
| Slovenia | Site Ref # / Investigator 59795 | Maribor | |
| Slovenia | Site Ref # / Investigator 59796 | Maribor | |
| Slovenia | Site Ref # / Investigator 59801 | Maribor | |
| Slovenia | Site Ref # / Investigator 59803 | Novo Mesto | |
| United Arab Emirates | Site Ref # / Investigator 59502 | Abudhabi | |
| United Arab Emirates | Site Ref # / Investigator 59506 | Abudhabi | |
| United Arab Emirates | Site Ref # / Investigator 59513 | Abudhabi | |
| United Arab Emirates | Site Ref # / Investigator 59524 | Abudhabi | |
| United Arab Emirates | Site Ref # / Investigator 59526 | Abudhabi | |
| United Arab Emirates | Site Ref # / Investigator 59528 | Abudhabi | |
| United Arab Emirates | Site Ref # / Investigator 59516 | Ajman | |
| United Arab Emirates | Site Ref # / Investigator 59519 | Ajman | |
| United Arab Emirates | Site Ref # / Investigator 59514 | Alain | |
| United Arab Emirates | Site Ref # / Investigator 59532 | Alain | |
| United Arab Emirates | Site Ref # / Investigator 54493 | Dubai | |
| United Arab Emirates | Site Ref # / Investigator 59504 | Dubai | |
| United Arab Emirates | Site Ref # / Investigator 59505 | Dubai | |
| United Arab Emirates | Site Ref # / Investigator 59508 | Dubai | |
| United Arab Emirates | Site Ref # / Investigator 59509 | Dubai | |
| United Arab Emirates | Site Ref # / Investigator 59511 | Dubai | |
| United Arab Emirates | Site Ref # / Investigator 59517 | Dubai | |
| United Arab Emirates | Site Ref # / Investigator 59518 | Dubai | |
| United Arab Emirates | Site Ref # / Investigator 59521 | Dubai | |
| United Arab Emirates | Site Ref # / Investigator 59523 | Dubai | |
| United Arab Emirates | Site Ref # / Investigator 59525 | Dubai | |
| United Arab Emirates | Site Ref # / Investigator 59529 | Dubai | |
| United Arab Emirates | Site Ref # / Investigator 59531 | Dubai | |
| United Arab Emirates | Site Ref # / Investigator 59533 | Dubai | |
| United Arab Emirates | Site Ref # / Investigator 59534 | Dubai | |
| United Arab Emirates | Site Ref # / Investigator 59510 | Rak | |
| United Arab Emirates | Site Ref # / Investigator 59515 | Rak | |
| United Arab Emirates | Site Ref # / Investigator 59507 | Sharjah | |
| United Arab Emirates | Site Ref # / Investigator 59512 | Sharjah | |
| United Arab Emirates | Site Ref # / Investigator 59522 | Sharjah | |
| United Arab Emirates | Site Ref # / Investigator 59527 | Sharjah | |
| United Arab Emirates | Site Ref # / Investigator 59530 | Sharjah | |
| United Arab Emirates | Site Ref # / Investigator 59535 | Sharjah |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott | Fovea |
Canada, Croatia, Germany, Kuwait, Romania, Russian Federation, Saudi Arabia, Slovenia, United Arab Emirates,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Baseline to Month 6 | No |
| Secondary | 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. | Baseline to Month 6 | No |
| Secondary | 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. | Baseline to Month 6 | No |
| Secondary | 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. | Baseline to Month 6 | No |
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