Clinical trial NCT00413764 (phase 3, status: completed)
Conditions: sexual dysfunction
ICD codes: R37, N53.8, N53.9, F10.181, F10.281, F11.181, F11.281
Drugs: tibolone, estradiol-norethisterone
SMILES: [H][C@@]12CC[C@@](O)(C#C)[C@@]1(C)CC[C@]1([H])C3=C(CC(=O)CC3)C[C@@]([H])(C)[C@@]21[H], [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=C(CC[C@@]21[H])C=C(O)C=C3
Eligibility criteria:

        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