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OpenTrials
Completed

NCT Number: NCT01724658

Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women

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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Key information

Conditions

Female Sexual Dysfunction

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

King Chulalongkorn memorial hospital

Bangkok, Bankok, 10330, Thailand

About this study

Research Question:

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

Study design:

Randomized double-blinded placebo controlled trial

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testosterone Undecanoate

Drug

testosterone undecanoate 40 mg orally twice a week

Other names: Andriol

Placebo

Drug

placebo orally twice a week with progynova 1 mg oral daily

Primary outcomes

  1. female sexual function index score

    Time frame: 8 weeks

Secondary outcomes

  1. adverse effects of the drug

    Time frame: 8 week

    • weight gain
    • acne
    • hirsutism.
    • vaginal bleeding

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 12, 2012
Registry last updated
Jan 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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