None listed
Conditions
Brief summary
The Primary Aim of this study is to assess the efficacy of transdermal testosterone therapy on sexual function over 3 months in women at midlife being treated for depression with a selective serotonin re-uptake inhibitor (SSRI) who are experiencing at least one of: loss of sexual desire, sexual arousal disorder or delayed orgasm/anorgasmia for which they desire treatment Study hypothesis Transdermal testosterone, compared with placebo, will result in a clinically meaningful improvement in the total score of the Sabbatsberg Sexual Self Rating Scale indicating improvement in sexual dysfunction secondary to the use of SSRI/SNRI medication .
Interventions
Administration of 300 micrograms/day transdermal testosterone via skin patch applied by the patient twice weekly. Patients will be required to wear the patch for 84 hours each time before removal. Patients will undergo the intervention treatment for 3 months.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
35 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Women: 1. who are aged 35 to 55 years on a stable dose of a Selective Serotonin Reuptake Inhibitor (sertraline, citalopram, paroxetine, fluoxetine or fluvoxamine) or a Selective Noradrenaline Reuptake Inhibitor (venlafaxine) for at least 3 months 2. are using a medically acceptable form of contraception: oral contraceptives (except those with antiandrogen component), injectable or implantable methods, intrauterine devices, properly used barrier contraception, bilateral tubal ligation or involvement in a monogamous relationship with a partner who has had a vasectomy (not required for hysterectomised / oophorectomised women or women with evidence of being >2 years postmenopausal), 3. have a negative pregnancy test at screening (not required for hysterectomised / oophorectomised women or women with evidence of being >2 years postmenopausal), 4. if using hormone replacement therapy have been on a stable dose for >3 months, excluding conjugated oestrogen (Premarin) or drospirenone. 5. have a clinically acceptable screening mammogram or documented results of a previous mammogram within 2 years of screening for women over 50 years; 6. have a clinically acceptable Pap smear within the past 2 years(no evidence of malignancy or squamous intraepithelial lesions) if the cervix is present; 7. who have provided informed consent by signing the approved consent agreement
Exclusion criteria
1. 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.
Outcome results
None listed