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

Organon

Status and phase

Completed

Phase 3

Conditions

Sexual Dysfunction

Treatments

Drug: estradiol-norethisterone

Drug: tibolone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00413764

P06089

C-1774

Details and patient eligibility

About

Tibolone has been registered for treatment of menopausal symptoms. It is, however, not known what the effects are of tibolone in postmenopausal women diagnosed with sexual dysfunction. This is important because there is currently no approved treatment of libido problems in postmenopausal women. Therefore, the primary aim of this study was to compare the effects of tibolone with an estrogen/progestogen skin patch in postmenopausal women diagnosed sexual dysfunction.

Enrollment

358 patients

Sex

Female

Ages

48 to 68 years old

Volunteers

No Healthy Volunteers

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