Phase 1
Completed N=12
ORAL T-8 Oral Testosterone for Male Hormonal Contraception
Healthy
Source: ClinicalTrials.gov NCT01167829 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Maximum Testosterone Concentration — 924; 741 ng/dL — p=0.05
Summary
The purpose of this study is to test how the body absorbs a new form of oral testosterone (T). On Day 1 and Day 9 there are overnight stays in the General Clinical Research Center at the University of Washington to monitor blood testosterone levels over a 24-hour period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Testosterone Concentration |
924; 741 | 0.05 |
| PRIMARY Mean Testosterone Concentration |
378; 315 | — |
| SECONDARY Maximum Dihydrotestosterone (DHT) Concentration |
233; 142 | — |
| SECONDARY Mean Dihydrotestosterone (DHT) Concentration |
96; 69 | — |
| SECONDARY Maximum Sex Hormone-Binding Globulin (SHGB)Concentration |
31; 22 | — |
| SECONDARY Mean SHGB Concentration |
27; 19 | — |
| SECONDARY Maximum Estradiol Concentration |
14; 9 | — |
| SECONDARY Mean Estradiol Concentration |
11; 7 | — |
| SECONDARY Free T Maximum Concentration |
24; 21 | — |
| SECONDARY Free Testosterone Mean Concentration |
8.7; 8.3 | — |
Eligibility Criteria
INCLUSION CRITERIA
- able and willing to
- not participate in another drug study or donate blood, not take medications
- use contraception, comply with the protocol
EXCLUSION CRITERIA
- abnormal evaluation, based on physical exam, medical history, blood tests (including serum chemistry, hematology, HIV, HCV, hormone levels)
- history or current use of alcohol, drug, steroid abuse, >3 alcohol drinks/day
- history of testicular disease, severe testicular trauma, major psychiatric disorder, bleeding disorders, current use of anti-coagulants or testosterone
- participation in hormonal drug study within past month
Data sourced from ClinicalTrials.gov (NCT01167829). 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.