Female Sexual DysfunctionPhase 2NCT01724658
Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women
A Phase 2 study testing Testosterone undecanoate in people with Female Sexual Dysfunction, run by Chulalongkorn University at 1 site in Thailand.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Sexual Dysfunction
- What is being tested?
- Testosterone undecanoate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2012to May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- postmenopausal women with age between 40-60 years
- Women complain about her sexual problem and her score of Female Sexual Function Index ≤ 26.5
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Female Sexual Dysfunction
- Being tested
- Testosterone undecanoate, placebo
- Keywords
- female sexual function, postmenopause, testosterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone undecanoateDrug
Also called Andriol
testosterone undecanoate 40 mg orally twice a week
placeboDrug
placebo orally twice a week with progynova 1 mg oral daily
| Study group | Role | What they receive |
|---|---|---|
| Testosterone undecanoate | Experimental | testosterone undecanoate 40 mg orally twice a week plus progynova 1mg oral daily Receives: Drug: Testosterone undecanoate |
| placebo | Placebo comparator | placebo twice a week with progynova 1 mg oral daily Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
female sexual function index score
Measured: 8 weeks
Secondary outcomes (1)
adverse effects of the drug
- weight gain
- acne
- hirsutism.
- vaginal bleeding
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startJun 2012
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Female Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reuthairat Tungmunsakulchai, MD, Principal investigator, Menopause unit of Chulalongkorn hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724658
- Sponsor's protocol ID
- CU0115
- Status last verified
- Jan 2014
- First submitted
- 12 Oct 2012
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
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 12626215Tungmunsakulchai 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01724658
- Acronym / sponsor ID
- CU0115
- Conditions
- Female Sexual Dysfunction
- Keywords
- female sexual function, postmenopause, testosterone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 12 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone undecanoate | Experimental | Drug: Testosterone undecanoatetestosterone undecanoate 40 mg orally twice a week plus progynova 1mg oral daily |
| placebo | Placebo comparator | Drug: placeboplacebo twice a week with progynova 1 mg oral daily |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- postmenopausal women with age between 40-60 years
- Women complain about her sexual problem and her score of Female Sexual Function Index ≤ 26.5
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone undecanoateAlso: Andrioltestosterone undecanoate 40 mg orally twice a week | Drug | Testosterone undecanoate |
| placeboplacebo orally twice a week with progynova 1 mg oral daily | Drug | placebo |
Primary outcome
female sexual function index score
Time frame: 8 weeks
1 secondary outcome
adverse effects of the drug
Time frame: 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
- Results publication: PubMed 12626215Floter 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.
- Derived from this study: PubMed 26631095Tungmunsakulchai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reuthairat Tungmunsakulchai, MD principal investigator
Menopause unit of Chulalongkorn hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Testosterone undecanoate in people with Female Sexual Dysfunction, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
female sexual function index score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01724658, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2014.