Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women

Chulalongkorn University

Status and phase: Completed; Phase 2

Conditions: Female Sexual Dysfunction

Treatments: Drug: Testosterone undecanoate; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01724658

CU0115

Details and patient eligibility

About

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.

Full 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

Enrollment: 70 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

70 participants in 2 patient groups, including a placebo group

Testosterone undecanoate

Experimental group

Description:

testosterone undecanoate 40 mg orally twice a week plus progynova 1mg oral daily

Treatment:

Drug: Testosterone undecanoate

placebo

Placebo Comparator group

Description:

placebo twice a week with progynova 1 mg oral daily

Treatment:

Drug: placebo