Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women
Information source: Chulalongkorn University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Female Sexual Dysfunction
Intervention: Testosterone undecanoate (Drug); placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Chulalongkorn University Official(s) and/or principal investigator(s):
Reuthairat Tungmunsakulchai, MD, Principal Investigator, Affiliation: Menopause unit of Chulalongkorn hospital
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.
Clinical Details
Official title: Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: female sexual function index score
Secondary outcome: adverse effects of the drug
Detailed 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
Eligibility
Minimum age: 40 Years.
Maximum age: 60 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
King Chulalongkorn memorial hospital, Bankok 10330, Thailand
Additional Information
Starting date: June 2012
Last updated: January 28, 2014
|
