Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia

Inclusion Criteria

• Subject agrees to participate in the study and has signed and dated the informed consent form prior to the initiation of any study-related activities.
• AGA classified utilizing the Norwood-Hamilton classification.
• Men 18 to 50 years old, inclusively.
• Fluent and literate in local language with the ability to comprehend and record information on the International Index of Erectile Function, Hair Growth Satisfaction Scale, and DLQI questionnaires.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is 2.0 ng/mL at screening.
• Serum creatinine >1.5xULN at screening.
• Unstable liver disease (chronic stable hepatitis B and C are acceptable if the subject otherwise meets entry criteria).
• History of malignancy (including prostate cancer) within the past 5 years, except basal cell or squamous cell carcinoma of the skin.
• History of prostate cancer before the age of 50 years in a first degree relative.
• History of breast cancer or clinical breast examination suggestive of malignancy.
• Any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening; and uncontrolled diabetes or peptic ulcer disease that is uncontrolled by medical management.
• History or current evidence of any serious and/or unstable pre-existing medical or psychiatric disorder, or other conditions that could, in the opinion of the investigator or the medical monitor, interfere with the subject's safety, obtaining informed consent, or compliance with study procedures.Note: the investigator may consult with the GSK medical monitor if a condition could interfere with the subject's safety.
• Global scalp hair thinning, including occipital areas.
• Scarring of the scalp, including prior hair transplant or scalp reduction, or any other condition or disease of the scalp or hair, including diseases of the hair shaft (e.g., tinea infection, non-androgenetic-cause of alopecia, psoriatic dermatitis or other psoriatic lesions, or uncontrolled seborrheic dermatitis).
• History of hair transplantation at any time to correct AGA or use of hair weaving within 6 months prior to screening.
• History or evidence of hair loss other than AGA (e.g., due to an auto-immune, endocrine, mechanical or infectious process, or secondary to a scalp dermatological disorder).
• Use of any cosmetic product aimed at improving or correcting the signs of hair loss (e.g., scalp preparations with claims aiming at improved hair growth) within 2 weeks prior to screening.
• Use of light or laser treatments on the scalp (e.g., light emitting diode [LED] lamps) within 3 months prior to screening.
• Hypersensitivity to any 5-alpha reductase inhibitor (5-ARI) or its components or excipients or drugs chemically related to the study treatment.
• Use of dutasteride within 10 months prior to screening or use of finasteride within 6 months prior to screening.
• Previous use of systemic cytotoxic agents.
• Use of glucocorticoids (inhaled glucocorticoids are allowed; topical corticosteroids are allowed provided that they are not used on the scalp) within 3 months prior to screening.
• Use of the following prior to Baseline (within 1 week for topical products; within

1 week or 5 half-lives, whichever is longer, for systemic treatments): Phosphodiesterase type 5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil); Minoxidil (oral or topical); Carpronium chloride; Systemic drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, and bicalutamide); Topical or systemic estrogen or progesterone; Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin, psoralens); Drugs potentially causing hypertrichosis or t