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

NCT00413764 | Completed Phase 3

• 2 other identifiers: P06089C-1774
• Study Type: interventional
• Target: 358
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Compare the effect of tibolone (2.5 mg) to transdermal E2/NETA (50/140 mcg) on the vaginal bleeding and spotting rate in healthy postmenopausal women with sexual dysfunction.

  Week 13-24 of the in treatment period

• Compare the effect of tibolone to E2/NETA on sexual functioning in healthy postmenopausal women with sexual dysfunction.

  Week 8-12 and Week 20-24 of the in-treatment period.

Secondary Outcomes (1)

• Compare the effects of tibolone to E2/NETA on the frequency of satisfactory sexual events, the frequency of sexual fantasies and subjective arousal, scores on the FSFI, FSDS, WHQ and endocrine parameters

  Week 8-12 and Week 20-24 of the in-treatment period

Study Arms (2)

1

EXPERIMENTAL

tibolone

Drug: tibolone

2

ACTIVE COMPARATOR

transdermal continuous combined E2-NETA (estradiol-norethisterone)

Drug: estradiol-norethisterone

Interventions

tibolone DRUG

tibolone (2.5 mg) over 24 weeks

Also known as: Livial®

1

estradiol-norethisterone DRUG

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

Also known as: Combipatch®, Estalis®

2

Eligibility Criteria

• Age: 48 Years - 68 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 18304284 RESULT

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

tibolone; estradiol, norethisterone, testosterone drug combination; estradiol, norethindrone drug combination

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2006
• First Posted: December 20, 2006
• Study Start: March 23, 2004
• Primary Completion: November 15, 2005
• Study Completion: November 15, 2005
• Last Updated: February 4, 2022

Record last verified: 2022-02