Efficacy of Tibolone Versus Transdermal E2/NETA on Sexual Function in Naturally Postmenopausal Women (P06089)

Inclusion criteria

• Physically and mentally healthy postmenopausal women, >=48 and <=68 years of age, with an intact uterus.
• Women were to suffer from decreased satisfactory sexual activity compared to younger age and sexual problems were not to be considered caused by relationship/partner problems. The decreased sexual functioning was to result in sexually related personal distress as confirmed by the FSDS (score =15).
• An affirmative answer was to be given to the following questions: (a) In previous years did you find sexual activity satisfying? (b) Has there been a decline in your satisfaction with sexual activity? (c) Are you satisfied with your partner as a friend?
• All subjects were to have an established sexual relationship of at least 6 months duration prior to screening.
• Women were to be sexually active.
• Normal mammography within 6 months prior to randomization.
• Body mass index >18 and <=32 kg/m2.
• Voluntary written informed consent

Exclusion criteria

• Any unexplained abnormal uterine bleeding
• Double layer endometrial thickness >4 mm
• Tibolone or transdermal E2/NETA use within 3 months prior to screening
• Progestogen implants or injections and estrogen/progestogen injectable therapy within 6 months prior to screening
• Use of intra-uterine progestogen
• Unsuccessful previous treatment with androgens or compounds known to enhance androgenic activity
• Current successful treatment with androgens, without applying the applicable washout period of 3 months prior to screening
• Any previous or current unopposed estrogen administration, prior use of estrogen pellets or tamoxifen citrate (previous low dose vaginal estrogen-only applications are allowed)
• Use of anti -androgens within the preceding 5 years prior to screening.
• Women with significant organic disorder of sexual dysfunction or a partner with sexual dysfunction
• Women who had early onset sexual dysfunction (>15 years prior to menopause)
• Women suffering from androgenic alopecia, acne or hirsutism
• Women suffering from illnesses influencing sexuality
• Women using medication influencing sexuality
• Moderate to severe depression
• Current or prior use of antidepressant within 8 weeks prior to screening
• Major gynecological surgery in the preceding 3 months
• Any serious disease or disorder; or any endocrine disorder with systemic disease which would have impaired overall health and well being (controlled hypo/hyperthyroidism and diabetes mellitus Type II was allowed)
• History or presence of severe psychiatric illness and/or any addictions to drugs, medication or alcohol in the past 3 years
• Diseases for which exogenous hormonal steroids were contraindicated.
• History or presence of any malignancy, except successfully treated non-melanoma skin cancers
• History or presence of cardiovascular or cerebrovascular conditions, thrombosis or thromboembolic disorders
• History or presence of liver, gallbladder or renal disease, epilepsy or classical migraine headaches
• Uncontrolled hypertension
• Women with abnormal cervical smear results
• History or presence of breast cancer, suspicious breast lump or mammographic abnormality
• Known hypersensitivity to any of the ingredients of the trial medication.
• Non-compliance with the screening diary
• Current use of raloxifene, clonidine, veralipride, phytoestrogen extracts
• Drugs known to interfere with the pharmacokinetics of the steroids
• Use of investigational drugs within the past 60 days
• Any disease or condition that was clinically relevant and which, in the opinion of the investigator, would have jeopardized the subject's well being during the course of the trial