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CompletedNCT01724658Updated Jan 29, 2014

Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women

A Phase 2 interventional study of Testosterone undecanoate and placebo in Female Sexual Dysfunction, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to female participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-29.

Sponsored by Chulalongkorn University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
Female
01

Study 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.

Read the 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

02

Conditions studied

  • Female Sexual Dysfunction

Keywords

  • female sexual function
  • postmenopause
  • testosterone
03

In context

Lead sponsor

Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Testosterone undecanoate

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

    Drug: Testosterone undecanoate

  • Placebo comparator
    placebo

    placebo twice a week with progynova 1 mg oral daily

    Drug: placebo

Interventions

  • DrugTestosterone undecanoate

    testosterone undecanoate 40 mg orally twice a week

    Also known as: Andriol

  • Drugplacebo

    placebo orally twice a week with progynova 1 mg oral daily

06

What researchers measure

Primary outcomes

  1. female sexual function index score

    Time frame: 8 weeks

Secondary outcomes

  1. adverse effects of the drug

    1. weight gain 2. acne 3. hirsutism. 4. vaginal bleeding

    Time frame: 8 week

07

Study locations

1 site
  • King Chulalongkorn memorial hospital
    Bankok, 10330, Thailand
08

References and documents

Publications

  • 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. PubMed 12626215 ↗
  • Tungmunsakulchai 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. PubMed 26631095 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01724658
Lead sponsor
Chulalongkorn University
Responsible party
Sponsor
First posted
Nov 12, 2012
Start date
Jun 2012
Primary completion
Apr 2013
Completion
May 2013
Last update
Jan 29, 2014

Study contacts

Reuthairat Tungmunsakulchai, MD
principal investigator · Menopause unit of Chulalongkorn hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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