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

NCT ID: NCT00413764

Last Updated: 2022-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 358 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-23
• Study Completion Date: 2005-11-15

Brief Summary

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.

Conditions

Sexual Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

tibolone

Group Type: EXPERIMENTAL

tibolone

Intervention Type: DRUG

tibolone (2.5 mg) over 24 weeks

2

transdermal continuous combined E2-NETA (estradiol-norethisterone)

Group Type: ACTIVE_COMPARATOR

estradiol-norethisterone

Intervention Type: DRUG

transdermal continuous combined E2-NETA (estradiol-norethisterone 50/140 mcg) over 24 weeks

Interventions

tibolone

tibolone (2.5 mg) over 24 weeks

Intervention Type: DRUG

estradiol-norethisterone

transdermal continuous combined E2-NETA (estradiol-norethisterone 50/140 mcg) over 24 weeks

Intervention Type: DRUG

Other Intervention Names

Livial®; Combipatch®; Estalis®

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

• Minimum Eligible Age: 48 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Nijland EA, Weijmar Schultz WC, Nathorst-Boos J, Helmond FA, Van Lunsen RH, Palacios S, Norman RJ, Mulder RJ, Davis SR; LISA study investigators. Tibolone and transdermal E2/NETA for the treatment of female sexual dysfunction in naturally menopausal women: results of a randomized active-controlled trial. J Sex Med. 2008 Mar;5(3):646-56. doi: 10.1111/j.1743-6109.2007.00726.x.

Reference Type: RESULT

PMID: 18304284 (View on PubMed)

Other Identifiers

C-1774

Identifier Type: -

Identifier Source: secondary_id

P06089

Identifier Type: -

Identifier Source: org_study_id