Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-05-31

Brief Summary

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Additional testosterone undecanoate can improve female sexual function in postmenopausal women which one aspects of quality of life. The dose adjustment can reduce incidence of adverse effects and low cost of treatment with effective outcome.

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Detailed Description

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Research Question:

" Does oral testosterone undecanoate improve sexual problem in postmenopausal women? " Type Research:Clinical research

Study design:

Randomized double-blinded placebo controlled trial

Conditions

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Female Sexual Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Testosterone undecanoate

testosterone undecanoate 40 mg orally twice a week plus progynova 1mg oral daily

Group Type EXPERIMENTAL

Testosterone undecanoate

Intervention Type DRUG

testosterone undecanoate 40 mg orally twice a week

placebo

placebo twice a week with progynova 1 mg oral daily

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo orally twice a week with progynova 1 mg oral daily

Interventions

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Testosterone undecanoate

testosterone undecanoate 40 mg orally twice a week

Intervention Type DRUG

placebo

placebo orally twice a week with progynova 1 mg oral daily

Intervention Type DRUG

Other Intervention Names

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Andriol

Eligibility Criteria

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Inclusion Criteria

* postmenopausal women with age between 40-60 years
* Women complain about her sexual problem and her score of Female Sexual Function Index ≤ 26.5

Exclusion Criteria

* women with previous use of hormonal replacement or anti-psychiatric drugs within 3 months
* women with history of or present premalignancies/malignancies
* women present with liver disease or abnormal liver enzyme
* women with active cardiovascular, cerebrovascular or thromboembolic disorders
* women with Present psychiatric disease
* Partner have sexual dysfunction

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes