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Trial record 11 of 212 for:    female sexual dysfunction
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Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women

This study is currently recruiting participants.
Verified October 2012 by Chulalongkorn University
Sponsor:
Information provided by (Responsible Party):
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01724658
First received: October 12, 2012
Last updated: November 7, 2012
Last verified: October 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • female sexual function index score [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • adverse effects of the drug [ Time Frame: 8 week ] [ Designated as safety issue: Yes ]
    1. weight gain ......kg
    2. acne -mild -moderate -severe
    3. hirsutism. -mild -moderate -severe
    4. vaginal bleeding -mild -moderate -severe


Estimated Enrollment: 70
Study Start Date: June 2012
Estimated Study Completion Date: May 2013
Estimated 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
Other Name: placebo

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

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age group : 40-60 years
  • postmenopausal women
  • Women complain about her sexual problem and her score of Female Sexual Function Index ≤ 26.5

Exclusion Criteria:

  • Previous use of hormonal replacement or anti-psychiatric drugs within 3 months
  • History of or present premalignancies/malignancies
  • Present liver disease or abnormal liver enzyme
  • Active cardiovascular, cerebrovascular or thromboembolic disorders
  • Present psychiatric disease
  • Partner have sexual dysfunction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724658

Contacts
Contact: Reuthairat Tungmunsakulchai, MD +668 6852 1449 tungmunsakulchai@yahoo.com
Contact: Sukanya Chaikittisilp, MD +6681-8145650 sukanya.c@chula.ac.th

Locations
Thailand
King Chulalongkorn memorial hospital Recruiting
Bankok, Thailand, 10330
Contact: reuthairat tungmunsakulchai, MD     +668 6852 1449     tungmunsakulchai@yahoo.com    
Contact: sukanya chaikittisilp, MD     +668 1814 5650     sukanya.c@chula.ac.th    
Principal Investigator: reuthairat tungmunsakulchai, MD            
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Reuthairat Tungmunsakulchai, MD Menopause unit of Chulalongkorn hospital
  More Information

Publications:

Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01724658     History of Changes
Other Study ID Numbers: CU0115
Study First Received: October 12, 2012
Last Updated: November 7, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:
female sexual function
postmenopause
testosterone

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on May 16, 2013