Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women
Phase 2
Completed
- Conditions
- Female Sexual Dysfunction
- Interventions
- Drug: placebo
- Registration Number
- NCT01724658
- Lead Sponsor
- Chulalongkorn University
- Brief 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 70
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo placebo twice a week with progynova 1 mg oral daily Testosterone undecanoate Testosterone undecanoate testosterone undecanoate 40 mg orally twice a week plus progynova 1mg oral daily
- Primary Outcome Measures
Name Time Method female sexual function index score 8 weeks
- Secondary Outcome Measures
Name Time Method adverse effects of the drug 8 week 1. weight gain
2. acne
3. hirsutism.
4. vaginal bleeding
Trial Locations
- Locations (1)
King Chulalongkorn memorial hospital
🇹🇭Bankok, Thailand