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ABT-SLV176 in Hypogonadal Men
NCT02082197Phase 3
Key facts
- Status
- Withdrawn
- Start
- Mar 2014
- Primary completion
- Jun 2015
- Countries
- 1
- Sponsor
- AbbVie Inc.
- Modality
- Small Molecules
- Drugs
- testosterone
- Conditions
- Hypogonadism
01
Overview
Phase 3, open-label, single-arm trial of testosterone in Hypogonadism, sponsored by AbbVie Inc. Primary endpoint: Serum Total Testosterone Average Concentration Cavg(0-24) at Week 12. Planned start Mar 2014; status: withdrawn.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
ABT-SLV176
ABT-SLV176 administered daily
03
Who it enrols
Men with hypogonadism (low testosterone) are eligible. Patients with normal testosterone levels, elevated PSA, or a history of breast or prostate cancer are excluded.
04
Endpoints
Primary
Serum Total Testosterone Average Concentration Cavg(0-24)
Secondary
Maximum Total Testosterone Concentration
Average Serum Total Testosterone and Dihydrotestosterone (DHT) Concentration
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