Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 12, 2012
CompletedFirst Posted
Study publicly available on registry
November 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedJanuary 29, 2014
January 1, 2014
10 months
October 12, 2012
January 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
female sexual function index score
8 weeks
Secondary Outcomes (1)
adverse effects of the drug
8 week
Study Arms (2)
Testosterone undecanoate
EXPERIMENTALtestosterone undecanoate 40 mg orally twice a week plus progynova 1mg oral daily
placebo
PLACEBO COMPARATORplacebo twice a week with progynova 1 mg oral daily
Interventions
testosterone undecanoate 40 mg orally twice a week
Eligibility Criteria
You may qualify if:
- postmenopausal women with age between 40-60 years
- Women complain about her sexual problem and her score of Female Sexual Function Index ≤ 26.5
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King Chulalongkorn memorial hospital
Bangkok, Bankok, 10330, Thailand
Related Publications (2)
Floter A, Nathorst-Boos J, Carlstrom 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.
PMID: 12626215RESULTTungmunsakulchai R, Chaikittisilpa S, Snabboon T, Panyakhamlerd K, Jaisamrarn U, Taechakraichana N. Effectiveness of a low dose testosterone undecanoate to improve sexual function in postmenopausal women. BMC Womens Health. 2015 Dec 2;15:113. doi: 10.1186/s12905-015-0270-6.
PMID: 26631095DERIVED
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Reuthairat Tungmunsakulchai, MD
Menopause unit of Chulalongkorn hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2012
First Posted
November 12, 2012
Study Start
June 1, 2012
Primary Completion
April 1, 2013
Study Completion
May 1, 2013
Last Updated
January 29, 2014
Record last verified: 2014-01