Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women

Female Sexual Dysfunction Clinical Trial

Official title:

Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01724658
• Other study ID #: CU0115
• Status: Completed
• Phase: Phase 2
• First received: October 12, 2012
• Last updated: January 28, 2014
• Start date: June 2012
• Est. completion date: May 2013

Study information

• Verified date: January 2014
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Research Question:

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

Study design:

Randomized double-blinded placebo controlled trial

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Female Sexual Dysfunction

Intervention

Drug:
• Testosterone undecanoate
testosterone undecanoate 40 mg orally twice a week
• placebo
placebo orally twice a week with progynova 1 mg oral daily

Locations

Country	Name	City	State
Thailand	King Chulalongkorn memorial hospital	Bankok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Flöter A, Nathorst-Böös J, Carlström K, von Schoultz B. Addition of testosterone to estrogen replacement therapy in oophorectomized women: effects on sexuality and well-being. Climacteric. 2002 Dec;5(4):357-65. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	female sexual function index score		8 weeks
Secondary	adverse effects of the drug	weight gain; acne; hirsutism.; vaginal bleeding	8 week