420
Participants
Start Date
October 25, 2018
Primary Completion Date
September 6, 2024
Study Completion Date
September 6, 2024
Nestorone + Testosterone Combination Gel
The combined gel is a transdermal treatment that will be applied daily for 52 weeks to a male subject's arms and shoulders. The formulation will be a hydro alcoholic gel. About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume.
University of Pennsylvania Medical Center, Philadelphia
Eastern Virginia Medical School-EVMS Obstetrics & Gynecology, Norfolk
University of Bologna, Italy, Bologna
University of Kansas, Kansas City
Comprehensive Women's Health Center, Denver
University of Utah, Salt Lake City
The Lunquist Institute at Harbor-UCLA Medical Center, Torrance
UC Davis Health, Sacramento
Oregon Health & Science University, Portland
University of Washington Medical Center & Health Sciences, Seattle
Centro de Medicina Reproductiva Shady Grove Chile, Santiago
Chilean Institute of Reproductive Medicine, Santiago
Kenyatta National Hospital, Nairobi
Karolinska Institutet, Stockholm
University of Edinburgh, Edinburgh
University of Manchester, UK, Manchester
Spilhaus Clinical Research Site, Harare
Lead Sponsor
Population Council
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Premier Research
OTHER