Hypoactive Sexual Desire DisorderPhase 3NCT00131495
Study of Transdermal Testosterone Patches in Menopausal Women With Low Libido
A Phase 3 study testing Testosterone (transdermal patches) in people with Hypoactive Sexual Desire Disorder, run by Warner Chilcott at 1 site in Australia.
Trial summary
This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal testosterone patch in naturally or surgically menopausal women with low libido who are not receiving systemic estrogen or estrogen progestin therapy. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Hypoactive Sexual Desire Disorder
- What is being tested?
- Testosterone (transdermal patches)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 814 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2004to Feb 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be a generally healthy surgically menopausal woman (12 months), 20 to 70 years of age, not receiving any systemic estrogen or estrogen progestin therapy
- Be a generally healthy naturally menopausal woman (2 years since last period), 40 to 70 years of age, not receiving any systemic estrogen or estrogen progestin therapy.
- Be, in their own judgment, in a stable monogamous sexual relationship for at least one year prior to study entry that is perceived to be secure and communicative with the same partner who is sexually functional and physically present at least 50% of the time.
- Answer affirmatively to ALL of the following questions:
- Was the patient's sex life before menopause good and satisfying in general?
- Since menopause, has a meaningful loss in the level of desire for sex occurred?
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- Since menopause, has a significant decrease in sexual activity occurred?
- Is the current level of desire for or interest in sex bothering or concerning?
- Is an increase in the level of interest in or desire for sex and sexual activity desired?
Who cannot join
- Physical limitations that would interfere with normal sexual function;
- Estrogen use in the last 12 weeks (vaginal estriol or low dose vaginal estradiol accepted)
- Use of any of the following medications:
- antiandrogen therapy or topical minoxidil (last 5 years),
- androgen therapy (past 3 months/implantable past 7 months),
- systemic corticosteroids,
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- selective serotonin reuptake inhibitors (SSRIs),
- tricyclic anti-depressants,
- anti-androgens,
- systemic beta-blockers,
- anti-adrenergics,
- spironolactone,
- apomorphine,
- phosphodiesterase type 5 (PDE5) inhibitors (e.g., Viagra, tibolone or selective estrogen receptor modulators (SERMs), including tamoxifen (last 12 weeks))
- Be experiencing any chronic or acute life stress relating to any major life change that may significantly interfere with sexual function;
- Have significant psychiatric disorder (including mild depressive disorder - Beck Depression Inventory-II score of > 14;
- Have current severe dermatological problems or a known suspected hypersensitivity or allergy to any adhesive or any of the constituents of the transdermal testosterone patch
- Have evidence of or history of malignancy (estrogen dependent or any gynecological cancer) within the last 5 years;
- Have diabetes mellitus, active gallbladder disease, unstable thyroid disease, history of cerebrovascular disease, thrombo-embolic disorders, myocardial infarction or angina within the last 5 years or other significant organic disease that would prevent the patient from completing the study, or otherwise affect the outcome of the study.
- Have significant abnormal pretreatment laboratory parameters.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Monash Medical School, The Alfred Hospital
Prahran, Victoria, VIC 3181
About this study
Official title: A Randomized, Double-Blind, Placebo-controlled, Parallel-group, 52-week Study to Evaluate the Efficacy/Safety of Transdermal Patches Delivering Testosterone in Menopausal Women With Low Libido Not Receiving Estrogen Therapy
This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal testosterone patch in naturally or surgically menopausal women with low libido who are not receiving systemic estrogen or estrogen progestin therapy.
Read the detailed description
Detailed Description:
Hypoactive sexual desire disorder (HSDD) is a condition suffered by as many as 32% of the menopausal population. It is generally defined as a low libido which causes distress. Testosterone therapy (transdermal patch) is currently under investigation for this disorder and results of three phase 3 trials have shown evidence of efficacy in menopausal patients on hormone replacement therapy. Low libido does not discriminate between those women utilizing hormone replacement therapy and those who do not. This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal testosterone patch in naturally or surgically menopausal women with low libido who are not receiving systemic estrogen or estrogen progestin therapy. Persons could elect to go into a single blind study for one year after completing the first yeat double blind
- Conditions
- Hypoactive Sexual Desire Disorder
- Being tested
- Testosterone (transdermal patches), Placebo patch
- Keywords
- Low Libido, Low Desire, Distress
- 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.
Testosterone (transdermal patches)Drug
Testosterone patch (300mcg/day, changed twice a week for one year
Placebo patchDrug
placebo patch changed twice a week for one year
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo patch Receives: Drug: Placebo patch |
| 2 | Experimental | Testosterone patch (300mcg/day, changed twice a week for one year Receives: Drug: Testosterone (transdermal patches) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total satisfying sexual activity over 24 weeks
Measured: 6, 12, 24, 36, and 52 weeks
Secondary outcomes (5)
Sexual desire
Measured: 6, 12, 24, 36, and 52 weeks
personal distress
Measured: 6, 12, 24, 36, and 52 weeks
other domains of the Profile of Female Sexual Function over 24 weeks
Measured: 6, 12, 24, 36, and 52 weeks
mood, energy and well-being
Measured: 6, 12, 24, 36, and 52 weeks
menopausal symptoms
Measured: 6, 12, 24, 36, and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2005 (estimated)
- Study startJul 2004
- Primary completionFeb 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 814 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sue Davis, MD, Principal investigator, Monash Medical School, The Alfred Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131495
- Sponsor's protocol ID
- 2004031 and Yr 2 SB
- Status last verified
- Apr 2013
- First submitted
- 16 Aug 2005
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Davis SR, Moreau M, Kroll R, Bouchard C, Panay N, Gass M, Braunstein GD, Hirschberg AL, Rodenberg C, Pack S, Koch H, Moufarege A, Studd J; APHRODITE Study Team. Testosterone for low libido in postmenopausal women not taking estrogen. N Engl J Med. 2008 Nov 6;359(19):2005-17. doi: 10.1056/NEJMoa0707302.
PubMed 18987368
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
- A Randomized, Double-Blind, Placebo-controlled, Parallel-group, 52-week Study to Evaluate the Efficacy/Safety of Transdermal Patches Delivering Testosterone in Menopausal Women With Low Libido Not Receiving Estrogen Therapy
- ClinicalTrials.gov ID
- NCT00131495
- Acronym / sponsor ID
- 2004031 and Yr 2 SB
- Conditions
- Hypoactive Sexual Desire Disorder
- Keywords
- Low Libido, Low Desire, Distress
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 814 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 18 Aug 2005 (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.
This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal testosterone patch in naturally or surgically menopausal women with low libido who are not receiving systemic estrogen or estrogen progestin therapy.
Detailed description
Detailed Description:
Hypoactive sexual desire disorder (HSDD) is a condition suffered by as many as 32% of the menopausal population. It is generally defined as a low libido which causes distress. Testosterone therapy (transdermal patch) is currently under investigation for this disorder and results of three phase 3 trials have shown evidence of efficacy in menopausal patients on hormone replacement therapy. Low libido does not discriminate between those women utilizing hormone replacement therapy and those who do not. This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal testosterone patch in naturally or surgically menopausal women with low libido who are not receiving systemic estrogen or estrogen progestin therapy. Persons could elect to go into a single blind study for one year after completing the first yeat double blind
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo patchPlacebo patch |
| 2 | Experimental | Drug: Testosterone (transdermal patches)Testosterone patch (300mcg/day, changed twice a week for one year |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be a generally healthy surgically menopausal woman (12 months), 20 to 70 years of age, not receiving any systemic estrogen or estrogen progestin therapy
- Be a generally healthy naturally menopausal woman (2 years since last period), 40 to 70 years of age, not receiving any systemic estrogen or estrogen progestin therapy.
- Be, in their own judgment, in a stable monogamous sexual relationship for at least one year prior to study entry that is perceived to be secure and communicative with the same partner who is sexually functional and physically present at least 50% of the time.
- Answer affirmatively to ALL of the following questions:
Key exclusion criteria (20 listed)
- Physical limitations that would interfere with normal sexual function;
- Estrogen use in the last 12 weeks (vaginal estriol or low dose vaginal estradiol accepted)
- Use of any of the following medications:
- Be experiencing any chronic or acute life stress relating to any major life change that may significantly interfere with sexual function;
- Have significant psychiatric disorder (including mild depressive disorder - Beck Depression Inventory-II score of > 14;
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 (transdermal patches)Testosterone patch (300mcg/day, changed twice a week for one year | Drug | 2 |
| Placebo patchplacebo patch changed twice a week for one year | Drug | 1 |
Primary outcome
Total satisfying sexual activity over 24 weeks
Time frame: 6, 12, 24, 36, and 52 weeks
5 secondary outcomes
Sexual desire
Time frame: 6, 12, 24, 36, and 52 weeks
personal distress
Time frame: 6, 12, 24, 36, and 52 weeks
other domains of the Profile of Female Sexual Function over 24 weeks
Time frame: 6, 12, 24, 36, and 52 weeks
mood, energy and well-being
Time frame: 6, 12, 24, 36, and 52 weeks
menopausal symptoms
Time frame: 6, 12, 24, 36, and 52 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.
- Derived from this study: PubMed 18987368Davis SR, Moreau M, Kroll R, Bouchard C, Panay N, Gass M, Braunstein GD, Hirschberg AL, Rodenberg C, Pack S, Koch H, Moufarege A, Studd J; APHRODITE Study Team. Testosterone for low libido in postmenopausal women not taking estrogen. N Engl J Med. 2008 Nov 6;359(19):2005-17. doi: 10.1056/NEJMoa0707302.
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.
Sue Davis, MD principal investigator
Monash Medical School, The Alfred Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Testosterone (transdermal patches) in people with Hypoactive Sexual Desire Disorder, run by Warner Chilcott at 1 site in Australia.
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 9 inclusion and 20 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 1 site in Australia. 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?
Total satisfying sexual activity over 24 weeks (time frame: 6, 12, 24, 36, and 52 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 NCT00131495, which also lists 1 linked publication.
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.