Effects of TAK-448 in Middle-aged and Older Men With Low Testosterone

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Low Testosterone

In brief

The purpose of this study is to evaluate the effects on serum testosterone (ST) after 6 weeks of subcutaneous (SC) administration of different doses and dosing frequencies of TAK-448 to middle-aged and older men with low ST levels.

Key facts

Study ID

NCT02381288

Run by

Takeda

People needed

17

Starts

2015-09-10

Expected to finish

2016-04-08

Last updated by the study team

2017-05-17

Who can join

Age: 60 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Has total serum testosterone (ST) levels less than 300 ng/dL at Screening.
• Has a body mass index (BMI) between 20.0 and 40.0 kg/m\^2, inclusive at Screening.
• A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from the time of signing of informed consent throughout the duration of the study and for 12 weeks after the last dose.

You may not qualify if…

• Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality that may impact the ability of the participant to participate or potentially confound the study results. Participants will be excluded based on:
• Has a serum creatinine >2.0 milligrams per deciliter (mg/dL) at Screening.
• Is receiving dialysis treatment.
• Has an American Urological Association (AUA)/ International Prostate Symptom Score (I-PSS) score of >19 or serum prostate-specific antigen (PSA) >4 nanogram per milliliter (ng/mL) at Screening.
• Has thyrotropin (TSH) levels less than (<) 0.3 or >7.5 milli-international units per liter (mIU/L) at Screening.
• Has systolic blood pressure >160 millimeter of mercury (mm Hg) or diastolic blood pressure >100 mm Hg (if out of range may be repeated once for eligibility determination) at Screening.
• Has luteinizing hormone (LH) >9.4 units per liter (U/L) at Screening.
• Is receiving insulin therapy.
• Has a hematocrit <30 percent (%) or >48% at Screening.
• Has a glycosylated hemoglobin (HbA1c) >8.0 at Screening (Cohort 1).
• Has type 2 diabetes mellitus defined as fasting blood glucose >125 mg/dL, glycosylated hemoglobin (HbA1c) >6.2%, or use of antidiabetic medication (Cohort 2 only).
• Has clinical evidence of anatomic or pathological hypothalamic/pituitary/testicular disease, such as (but not limited to) Klinefelter's syndrome, Kallmann's syndrome, systemic infiltrative diseases (hemochromatosis, sarcoidosis, Wilson's disease), or prior pituitary surgery.
• Has used gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, antiandrogens, clomiphene, or other reproductive hormone-related agents within 6 months prior to Screening.
• Has used anabolic therapies (testosterone, dehydroepiandrosterone [DHEA], androstendione, any other androgen, or recombinant human growth hormone) within 1 year of Screening.

Where it is running

• Study site — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.