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Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01724658
First Posted: November 12, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chulalongkorn University
  Purpose
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.

Condition Intervention Phase
Female Sexual Dysfunction Drug: Testosterone undecanoate Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • female sexual function index score [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • adverse effects of the drug [ Time Frame: 8 week ]
    1. weight gain
    2. acne
    3. hirsutism.
    4. vaginal bleeding


Enrollment: 70
Study Start Date: June 2012
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Testosterone undecanoate
testosterone undecanoate 40 mg orally twice a week plus progynova 1mg oral daily
Drug: Testosterone undecanoate
testosterone undecanoate 40 mg orally twice a week
Other Name: Andriol
Placebo Comparator: placebo
placebo twice a week with progynova 1 mg oral daily
Drug: placebo
placebo orally twice a week with progynova 1 mg oral daily

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724658


Locations
Thailand
King Chulalongkorn memorial hospital
Bankok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Reuthairat Tungmunsakulchai, MD Menopause unit of Chulalongkorn hospital
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01724658     History of Changes
Other Study ID Numbers: CU0115
First Submitted: October 12, 2012
First Posted: November 12, 2012
Last Update Posted: October 12, 2017
Last Verified: January 2014

Keywords provided by Chulalongkorn University:
female sexual function
postmenopause
testosterone

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Estradiol valerate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Contraceptive Agents
Reproductive Control Agents