Hypoactive Sexual Desire DisorderPhase 3NCT00384046
Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen
A Phase 3 study testing Testosterone in people with Hypoactive Sexual Desire Disorder, run by Warner Chilcott at 31 sites in 5 countries.
Trial summary
The purpose of this study is to examine whether the transdermal testosterone system (TTS) is effective and safe in the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women who are on transdermal estrogen. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Hypoactive Sexual Desire Disorder
- What is being tested?
- Testosterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 272 participants
- Where
- 31 sitesin 5 countries
- Study dates
- Nov 2006to Jul 2007
- Phase
- Phase 3
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women will be screened for study participation according to the following inclusion criteria at Week -4. Eligible women must be a woman one year post menopausal, 40-70 years old in general good health on transdermal HRT and in a stable monogamous sexual relationship with low sexual desire causing distress.
Who cannot join
- Women will be screened for study participation according to the following exclusion criteria at Week -4 or as specified. Eligible women must not have any medical, physical, psychological, or pharmacological condition that could confound safety or efficacy.
Trial locations and contacts
31 sites in 5 countries.
31 sites in 5 countries
United Kingdom19 sites
Research Facility
Atherstone, CV9 1EU
Research Facility
Coventry, CV7 8LA
Research Facility
Doncaster, DN1 2ET
Site Facility
Headington, Oxford, OX3 9DU
Research Facility
Headington, OX3 9DU
Research Facility
Herts, SG6 4TS
Research Facility
Leicester, LE1 5WW
Research Facility
Leicester, LW1 5WW
Research Facility
Lichfield, WS14 9LH
Research Facility
London, NW8 9NH
Research Facility
London, SE1 9RT
Research Facility
London, SW1W 8RH
Research Facility
London, W12 0HS
Research Facility
London, W1G 7JW
Research Facility
London, W2 1NY
Research Facility
Plymouth, PL4 8QU
Research Facility
Salford, M8 8HD
Research Facility
Solihull, West Midlands, B91 2JL
Research Facility
Warks, CV9 1EU
Australia6 sites
Research Facility
Ashfield, New South Wales, 2131
Research Facility
Dulwich, South Australia, 5065
Research Facility
Gordon, New South Wales, 2072
Research Facility
Nedlands, Western Australia, 6009
Research Facility
Prahran, Victoria, 3181
Research Facility
Randwick, New South Wales, 2031
Germany3 sites
Research Facility
Aachen, D-52074
Research Facility
Hamburg, 20357
Research Facility
Münster, Münster, 48149
Canada2 sites
Research Facility
Montreal, Quebec, H1T 1P6
Research Facility
Québec, Quebec, G1S 2L6
About this study
Official title: 24-Week Study to Evaluate the Efficacy/Safety of Transdermal Testosterone in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder Receiving Systemic Transdermal Estrogen Therapy.
The purpose of this study is to examine whether the transdermal testosterone system (TTS) is effective and safe in the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women who are on transdermal estrogen.
Read the detailed description
This is a randomised, double-blind, placebo-controlled, parallel-group, multicentre, 24 week study to be conducted in approximately 300 patients at approximately 14 clinical sites in the UK, 6 sites in Australia, 5 sites in Germany, and 2 sites in Canada. Women will be randomised 1:1 to receive 300 mcg/day TTS or placebo for a 24 week period. Consistent with previous phase III studies, efficacy will be assessed over 24 weeks using the Sexual Activity Log (SAL), and at 12 and 24 weeks using the Profile of Female Sexual Function (PFSF) and Personal Distress Scale (PDS). Safety will be assessed over the entire 24 weeks. Hormone data (free and total testosterone, total estradiol, and sex hormone binding globulin) will be collected at Weeks -4 and 24. The total duration of treatment for each patient is 24 weeks.
- Conditions
- Hypoactive Sexual Desire Disorder
- Being tested
- Testosterone, Placebo
- Medical subject headings
- Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
patch, 300 mcg/day testosterone, patch changed every 3-4 days, 24 weeks
PlaceboDrug
patch, placebo, patch changed every 3-4 days, 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 300mcg/day testosterone Receives: Drug: Testosterone |
| 2 | Placebo comparator | Placebo arm Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of the TTS by measuring change in frequency of total satisfying episodes. The safety assessment of TTS with various parameters.
Measured: Assessment at 12 and 24 weeks
Secondary outcomes (1)
To assess the efficacy of the TTS as measured by the following parameters: changes in sexual desire, personal distress, and other domains of PFSF and SAL questionnaires.
Measured: Assessment at 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoactive Sexual Desire DisorderStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Imran A Lodhi, MD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384046
- Sponsor's protocol ID
- 2005108
- Status last verified
- Apr 2013
- First submitted
- 3 Oct 2006
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 24-Week Study to Evaluate the Efficacy/Safety of Transdermal Testosterone in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder Receiving Systemic Transdermal Estrogen Therapy.
- ClinicalTrials.gov ID
- NCT00384046
- Acronym / sponsor ID
- 2005108
- Conditions
- Hypoactive Sexual Desire Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 4 Oct 2006 (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.
The purpose of this study is to examine whether the transdermal testosterone system (TTS) is effective and safe in the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women who are on transdermal estrogen.
Detailed description
This is a randomised, double-blind, placebo-controlled, parallel-group, multicentre, 24 week study to be conducted in approximately 300 patients at approximately 14 clinical sites in the UK, 6 sites in Australia, 5 sites in Germany, and 2 sites in Canada. Women will be randomised 1:1 to receive 300 mcg/day TTS or placebo for a 24 week period. Consistent with previous phase III studies, efficacy will be assessed over 24 weeks using the Sexual Activity Log (SAL), and at 12 and 24 weeks using the Profile of Female Sexual Function (PFSF) and Personal Distress Scale (PDS). Safety will be assessed over the entire 24 weeks. Hormone data (free and total testosterone, total estradiol, and sex hormone binding globulin) will be collected at Weeks -4 and 24. The total duration of treatment for each patient is 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Testosterone300mcg/day testosterone |
| 2 | Placebo comparator | Drug: PlaceboPlacebo arm |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women will be screened for study participation according to the following inclusion criteria at Week -4. Eligible women must be a woman one year post menopausal, 40-70 years old in general good health on transdermal HRT and in a stable monogamous sexual relationship with low sexual desire causing distress.
Key exclusion criteria (1 listed)
- Women will be screened for study participation according to the following exclusion criteria at Week -4 or as specified. Eligible women must not have any medical, physical, psychological, or pharmacological condition that could confound safety or efficacy.
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 |
|---|---|---|
| Testosteronepatch, 300 mcg/day testosterone, patch changed every 3-4 days, 24 weeks | Drug | 1 |
| Placebopatch, placebo, patch changed every 3-4 days, 24 weeks | Drug | 2 |
Primary outcome
To assess the efficacy of the TTS by measuring change in frequency of total satisfying episodes. The safety assessment of TTS with various parameters.
Time frame: Assessment at 12 and 24 weeks
1 secondary outcome
To assess the efficacy of the TTS as measured by the following parameters: changes in sexual desire, personal distress, and other domains of PFSF and SAL questionnaires.
Time frame: Assessment at 12 and 24 weeks
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 17 Apr 2013.
Related trials for Hypoactive Sexual Desire Disorder
Not yet recruitingPhase 1/2
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder
Not yet recruitingPhase 2
An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD
Hypoactive Sexual Desire Disorder
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.
Imran A Lodhi, MD study director
Procter and Gamble
31 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Testosterone in people with Hypoactive Sexual Desire Disorder, run by Warner Chilcott at 31 sites in 5 countries.
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 1 inclusion and 1 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 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United Kingdom, Australia, Germany, Canada, Botswana. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To assess the efficacy of the TTS by measuring change in frequency of total satisfying episodes. The safety assessment of TTS with various parameters. (time frame: Assessment at 12 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2013.