Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women

January 28, 2014 updated by: Chulalongkorn University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bankok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
female sexual function index score
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse effects of the drug
Time Frame: 8 week
  1. weight gain
  2. acne
  3. hirsutism.
  4. vaginal bleeding
8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Reuthairat Tungmunsakulchai, MD, Menopause unit of Chulalongkorn hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

October 12, 2012

First Submitted That Met QC Criteria

November 7, 2012

First Posted (ESTIMATE)

November 12, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2014

Last Update Submitted That Met QC Criteria

January 28, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CU0115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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