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

NCT00413764 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2022-02-04

No results posted yet for this study

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

Interventions

DRUG

tibolone

tibolone (2.5 mg) over 24 weeks

DRUG

estradiol-norethisterone

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

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
48 Years
Max Age
68 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-23
Primary Completion
2005-11-15
Completion
2005-11-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00413764 on ClinicalTrials.gov