Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Testosterone · 1 trial · 1 indication
initial pharmacokinetics \[PK\] (day 1) of oral testosterone dosed 3 times daily and the PK after 9 days of treatment
initial 24-hour pharmacokinetics (PK) of oral testosterone dosed 3 times daily and post 24-hour PK after 9 days of treatment
| Arm | Type | Description |
|---|---|---|
| Acyline and oral testosterone | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Oral Testosterone | DRUG | Oral Testosterone: 300 mg, pills, three times daily Day 1 - 10 (total of 27 pills) |
| Acyline | DRUG | 300 ug/kg injection on Day 0 |
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, hematol...
Testosterone is being studied for use in male hormonal contraception. It is an investigational small molecule in Phase 1 clinical development. The completed trial, NCT01167829, enrolled 14 healthy male volunteers in the United States to evaluate oral testosterone for this purpose.
Testosterone is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research on this small molecule for male hormonal contraception. The investigational drug is currently in Phase 1 development.
Testosterone is in Phase 1 clinical development. The single trial, NCT01167829, has been completed. This Phase 1 study enrolled 14 healthy male participants in the United States to assess oral testosterone for male hormonal contraception.
Testosterone has one clinical trial, NCT01167829, titled "ORAL T-8 Oral Testosterone for Male Hormonal Contraception." This Phase 1 study was completed and enrolled 14 healthy male volunteers aged 18 years and older in the United States. The trial was uncontrolled and not randomized.
Testosterone is not FDA approved for male hormonal contraception. It is an investigational drug currently in Phase 1 clinical development. The completed trial, NCT01167829, was a Phase 1 study involving 14 healthy male volunteers in the United States.