PK Study of Testosterone Nasal Gel (TBS-2) in Healthy Premenopausal Women

Exclusion Criteria

• •Known history of hypersensitivity to Testosterone (e.g. Intrinsa patch) and/or related drugs.
• •Known history of polycystic ovarian syndrome.
• •Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, psychiatric, hematological, reproductive, liver or kidney disease, unless judged not clinically significant by the Principal Investigator or medical designate.
• •Presence of or known history of Estrogen-responsive tumors such as breast cancer and /or history of any cancer, excluding basal cell carcinoma.
• •Known history of frequent clinically significant acne.
• •Known history of hirsutism
• •History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, "nose job", or sinus surgery.
• •Prior nasal fractures.
• •Active allergies, such as rhinitis, rhinorrhea, and nasal congestion.
• •Mucosal inflammatory disorders, specifically pemphigus, and Sjogren's syndrome.
• •Sinus disease, specifically acute sinusitis, chronic sinusitis, or allergic fungal sinusitis.
• •History of nasal disorders or sleep apnea.
• •Use of any form of intra-nasal medication delivery, specifically nasal corticosteroids and oxymetazoline containing nasal sprays
• •History of Hepatitis B, a positive test for Hepatitis B surface antigen, a history of Hepatitis C, a positive test for Hepatitis C antibody, a history of HIV infection or demonstration of HIV antibodies.
• •Any history of severe allergic reaction (including drugs, food, insect bites, environmental allergens or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
• •Any history of drug abuse or alcohol abuse as per DSM-IV criteria within 6 months of study drug administration.
• •Current treatment with any hormone replacement therapy within previous 12 months, treatment with drugs which interfere with metabolism of Testosterone within 30 days of study drug administration and/or any other prescription medications. Difficulty in abstaining from OTC medication for the duration of study.
• •Use of oral, transdermal and implant contraceptives within 30 days prior to drug administration or a depot contraceptives injection within one year prior to drug administration.
• •Evidence of pregnancy or lactation.
• •Subjects who are breast feeding or have breast fed within the last six (6) months prior to the Screening Visit.
• •Administration of another investigational drug within 30 days prior to study medication administration.
• •Blood donation within 56 days prior to study medication administration.
• •Any participation as a plasma donor in a plasmapheresis program within seven days preceding screening in this study.
• •Intolerance to venipuncture.
• •History of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation.
• •History of Deep Venous Thrombosis or coagulation disorders.