Transdermal testosterone therapy: a potential treatment for selective serotonin reuptake inhibitor (SSRI)-associated sexual dysfunction in women.

Exclusion Criteria1

• Women with any of the following: (a) Have not had sexual function they consider satisfactory, prior to this episode of treatment for depression (b) Have a Body Mass Index<18 or > 40kg/m2 (c) Not sexually active (at least one sexual event per 28 days alone or with a partner) (d) Are found on the screening questionnaire to be experiencing any of the following: planning a pregnancy, breast feeding, significant dyspareunia; partnership problems / poor feeling for partner. (e) Have a Beck Depression Inventory-11 (BDI-II) score on screening > 28 ie severe depression (f) Have a sexual pain disorder (g) Have used recent androgen therapy (testosterone implant < 16 weeks ago, transdermal testosterone cream < 8 weeks ago, tibolone < 12 weeks ago, oral testosterone <4 weeks ago, injected testosterone<6 weeks ago) (h) Have sexual dysfunction caused by another medical condition (i) Current use of hormone replacement therapy containing conjugated oestrogen (Premarin) (j) Screening Sex Hormone Binding Globulin (SHBG)>160nmol/L (k) Have renal disease, history of cerebrovascular disease, thrombo-embolic disorders, myocardial infarction or angina at any time before study entry or thrombo-phlebitis within the last 5 years, or any other major illness that has occurred within the last 6 months. (l) Have undiagnosed genital bleeding (m) Have moderate to severe acne or hirsutism, have used antiandrogen therapy for acne or hirsutism in the preceding 5 years, have androgenic alopecia ( will exclude women with clinically meaningful androgen excess) (n) Active malignancy, or treatment for malignancy in the preceding 6 months (excluding non-melanotic skin cancer) (o) Report alcohol consumption > 3 standard drinks per day. (p) Have an abnormal thyroid stimulating hormone (TSH) value at screening confirmed by a Free T4 outside the normal laboratory range (patients with an abnormal TSH, normal Free T4 and no clinical signs or symptoms of thyroid disease, with or without replacement treatment, may be admitted to the study). (q) Have a history of Bipolar Disorder or Schizophrenia (r) Have a history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation (s) Any clinically significant skin abnormalities in the area of study drug application (Skin Irritation Scale must < 1 at Visit 2). 2. Women who, in the opinion of the investigator, are a poor medical or psychiatric risk for treatment in a research protocol. 3. Women who have participated in a medical or surgical research protocol in the preceding 28 days.