Phase 2
Completed N=11
Oral T7 Oral Testosterone in Man
Healthy Males · Male Contraceptive
Source: ClinicalTrials.gov NCT00842751 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcomePrimary: Maximum Testosterone Concentration — 471; 444; 543 ng*hr/dL
Summary
The purpose of this study is to test how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Testosterone Concentration |
471; 444; 543 | — |
| PRIMARY Serum Dihydrotestosterone Concentration |
154; 118; 125 | — |
| PRIMARY Serum Estradiol Concentration |
7.9; 6.5; 7.2 | — |
Eligibility Criteria
Inclusion Criteria
- Males between 18 and 50 years of age
- In good health based on normal screening evaluation (consisting of a medical history, physical exam normal serum chemistry, hematology, and baseline hormone levels.
- Must agree to not participate in another research drug study
- Must agree to not donate blood
- Must be willing to comply with the study protocol and procedures
Exclusion Criteria
- Men in poor general health, with abnormal blood results (clinical laboratory tests or hormone values)
- A known history of alcohol or drug abuse
- Participation in a long-term male contraceptive study within the past month
- History of bleeding disorders or current use of anti-coagulants
- History of sleep apnea
- History of major psychiatric disorder
- Body mass index > 37
- Infertility
- Hematocrit > 55 or 4
Data sourced from ClinicalTrials.gov (NCT00842751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.