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Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women

Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01724658
Enrollment
70
Registered
2012-11-12
Start date
2012-06-30
Completion date
2013-05-31
Last updated
2014-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Sexual Dysfunction

Keywords

female sexual function, postmenopause, testosterone

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

Interventions

DRUGTestosterone undecanoate

testosterone undecanoate 40 mg orally twice a week

DRUGplacebo

placebo orally twice a week with progynova 1 mg oral daily

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
female sexual function index score8 weeks

Secondary

MeasureTime frameDescription
adverse effects of the drug8 week1. weight gain 2. acne 3. hirsutism. 4. vaginal bleeding

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026