Testosterone for Low Sexual Desire in Premenopausal Women: A randomized, double-blind, placebo-controlled trial: The SYBIL study

Exclusion Criteria28

• Participants who meet any of the following criteria:
• Have any of the following:
• a. Significant organic disorder of sexual function e.g. dyspareunia or vaginismus
• b. Severe depression (Beck Depression score >28)
• c. New onset of vasomotor symptoms
• If partnered,
• d. Relationship problems / poor feeling for partner
• e. Partner with sexual dysfunction or a current partner who is absent > 50% of time
• BMI 40kg/m2
• Current or past (within 2 years prior to randomisation) androgen therapy including testosterone implant, tibolone, oral DHEA, testosterone cream, gel or troches
• Use of more than one psychotropic medication
• Participants with one current psychotropic medication will not be excluded provided they have been on stable therapy for at least 6 months
• Known severe psychiatric illness or eating disorder
• Uncontrolled hypertension with systolic blood pressure of > 140 mmHg and/or diastolic blood pressure of >90mmHg.
• Sex hormone binding globulin (SHBG) > 50% above upper female reference range if on the combined oral contraceptive pill
• A significant medical condition (e.g. hepatic/renal cardiovascular, endocrine including Type 1 or 2 diabetes mellitus) or any other major illness or surgical procedures that have occurred within the last 6 months prior to randomisation
• Participants with treated hypertension, treated hyperlipidaemia or treated thyroid disease will not be excluded provided they have been on stable therapy for at least 6 months prior to randomisation
• Any history of malignancy except non-melanotic skin cancer
• Alcohol consumption > 3 standard drinks per day or any addiction to drugs or medication within the past 5 years prior to randomisation
• Suspicious breast lump or mammographic abnormality, personal history of breast cancer
• Currently on medications, herbal remedies known to be strong inducers/ inhibitors of CYP 3A4 affect the production (e.g. opiates, GnRH agonists) or action (e.g. spironolactone) of androgens
• Planning to fall pregnant, are pregnant or breast feeding
• Participants who have been recently pregnant or breast feeding and have returned to a normal regular menstrual cycle will not be excluded from the study
• Treatment with anti-androgens for hirsutism in the previous 5 years prior to randomisation or who are concerned by their level of facial or body hair excess or are experiencing scalp hair loss consistent with androgenic alopecia
• Current or recent (less than 3 months prior to randomisation) treatment with COCP containing an anti-androgenic progestin (e.g drospirenone, cyproterone acetate, dienogest)
• Current history of moderate or severe acne at screening, or systemic treatment for acne with anti-androgens or roaccutane in the preceding 5 years prior to randomisation
• In the opinion of the investigator, a poor medical or psychiatric risk for treatment in a research protocol.
• Participation in a medical or surgical research protocol in the 28 days prior to randomisation.