Hypoactive Sexual Desire DisorderPhase 3NCT00467259
Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women
A Phase 3 study testing Testosterone Transdermal System in people with Hypoactive Sexual Desire Disorder, run by Warner Chilcott at 115 sites in United States.
Trial summary
This study is designed to evaluate the endometrial safety of a testosterone patch as treatment for low libido in naturally postmenopausal women. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Hypoactive Sexual Desire Disorder
- What is being tested?
- Testosterone Transdermal System
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,271 participants
- Where
- 115 sitesUnited States
- Study dates
- Apr 2007to Jan 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women will be screened for study participation and must be at least one year post menopausal, 45-70 years old, in general good health, and may or may not be on hormone therapy, and must have low sexual desire which causes distress.
Who cannot join
- Women will be screened for study participation and must not be using androgen therapy or have any medical, physical, psychological, or pharmacological condition that could make participation unsafe or confound the safety evaluation.
Trial locations and contacts
115 sites in 1 country.
115 sites in 1 country
United States115 sites
Research Facility
Alpharetta, Georgia, 30005
Research Facility
Anaheim, California, 92805
Research Facility
Atlanta, Georgia, 30342
Site Facility
Austin, Texas, 78705
Study Facility
Baltimore, Maryland, 21229
Research Facility
Baltimore, Maryland, 21285-6815
Research Facility
Beachwood, Ohio, 44122
Research Site
Berkeley, California, 94705
Site Facility
Billings, Montana, 59102
Research Facility
Bingham Farm, Michigan, 48025
Study Facility
Birmingham, Alabama, 35209
Research Facility
Birmingham, Alabama, 35233
Study Facility
Boston, Massachusetts, 02114
Research Facility
Boynton Beach, Florida, 33437
Study Facility
Bristol, Tennessee, 37620
Research Facility
Carrolton, Texas, 75007
Test Facility
Centerville, Ohio, 45459
Test Facility
Champaign, Illinois, 61820
Test Facility
Chandler, Arizona, 85225
Research Site
Charleston, West Virginia, 25301
Research Facility
Chattanooga, Tennessee, 37404
Test Facility
Chicago, Illinois, 60610
Research Facility
Cincinnati, Ohio, 45219
Study Facility
Cincinnati, Ohio, 45249
Research Facility
Cincinnati, Ohio, 45267-0457
Site Facility
Clearwater, Florida, 33759
Research Site
Cleveland, Ohio, 44106
Site Facility
Cleveland, Ohio, 44122
Test Facility
Columbus, Ohio, 43212
Test Facility
Columbus, Ohio, 43231
Site Facility
Corpus Christi, Texas, 78414
Research Facility
Dallas, Texas, 75231
Research Facility
Dayton, Ohio, 45409
Site Facility
Daytona Beach, Florida, 32114
Site Facility
Decatur, Georgia, 30034
Test Facility
Denver, Colorado, 80218
Site Facility
Douglasville, Georgia, 30134
Research Facility
Edina, Minnesota, 55435
Test Facility
Englewood, Ohio, 45322
Site Facility
Eugene, Oregon, 97401
Test Facility
Farmers Branch, Texas, 75234
Research Facility
Gainesville, Florida, 32601
Research Facility
Houston, Texas, 77030
Study Facility
Idaho Falls, Idaho, 83404
Test Facility
Indianapolis, Indiana, 46250
Research Facility
Irving, Texas, 75061
Research Site
Jackson, Mississippi, 39216
Research Site
Jacksonville, Florida, 32207
Site Facility
Jonesboro, Arkansas, 72401
Site Facility
Jupiter, Florida, 33458
Site Facility
Las Vegas, Nevada, 89146
Site Facility
Little Rock, Arkansas, 72223
Research Facility
Longmont, Colorado, 80501
Site Facility
Louisville, Kentucky, 40291
Test Facility
Miami, Florida, 33156
Research Facility
Midland, Texas, 79705
Research Facility
Mobile, Alabama, 36617
Research Facility
Montgomery, Alabama, 36116
Test Facility
Moorestown, New Jersey, 08057
Research Facility
Nashville, Tennessee, 37203
Test Facility
New London, Connecticut, 06320
Research Facility
New York, New York, 10016
Research Facility
Newport News, Virginia, 23606
Test Facility
Oklahoma City, Oklahoma
Research Site
Omaha, Nebraska, 68124
Research Facility
Overland Park, Kansas, 66202
Research Facility
Palm Desert, California, 92260
Research Facility
Pasadena, California, 91106
Study Facility
Paw Paw, Michigan, 49079
Study Facility
Peoria, Arizona, 85381
Research Facility
Philadelphia, Pennsylvania, 19114
Research Facility
Phoenix, Arizona, 85015
Research Facility
Phoenix, Arizona, 85032
Research Facility
Pinellas Park, Florida, 33781
Research Facility
Plantation, Florida, 33324
Test Facility
Raleigh, North Carolina, 27609
Test Facility
Reno, Nevada, 89502
Research Facility
Richardson, Texas, 75082
Study Facility
Richmond, Virginia, 23229
Test Facility
Richmond, Virginia, 23229
Site Facility
Richmond, Virginia, 23294
Site Facility
Roswell, Georgia, 30075
Test Facility
Saginaw, Michigan
Study Facility
Salt Lake City, Utah, 84117
Site Facility
San Antonio, Texas, 78229
Test Facility
San Antonio, Texas, 78229
Research Facility
San Diego, California, 92123
Research Facility
San Ramon, California, 94583
Test Facility
Santa Rosa, California, 95405
Test Facility
Savannah, Georgia, 31405
Research Facility
Scottsdale, Arizona, 85251
Site Facility
Seattle, Washington, 98105
Study Facility
South Miami, Florida, 33143
Test Facility
St Louis, Missouri, 63141
Research Facility
Tacoma, Washington, 98405
Test Facility
Tacoma, Washington, 98405
Research Site
Tampa, Florida, 33606
Research Site
Tucson, Arizona, 85712
Research Facility
Tucson, Arizona, 85715
Test Facility
Tulsa, Oklahoma, 74104
Study Facility
Tuscon, Arizona, 85741
Site Facility
Upland, California, 91786
Test Facility
Vero Beach, Florida, 32960
Research Facility
Virginia Beach, Virginia, 23452
Research Facility
Virginia Beach, Virginia, 23456
Research Facility
Vista, California, 92083
Site Facility
Vista, California, 92083
Research Facility
Washington D.C., District of Columbia, 20036
Study Facility
Waterbury, Connecticut, 06708
Research Facility
West Palm Beach, Florida, 33409
Research Facility
West Valley City, Utah, 84120
Site Facility
Westlake Village, California, 91361
Research Facility
Weston, Florida, 33326
Site Facility
Winston-Salem, North Carolina, 27103
Study Facility
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Double-Blind, Placebo-controlled, Multicenter, 52-week Study to Evaluate the Endometrial Safety of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder.
This study is designed to evaluate the endometrial safety of a testosterone patch as treatment for low libido in naturally postmenopausal women.
Read the detailed description
Naturally postmenopausal women with hypoactive sexual desire disorder (HSDD) will be randomized into a 52-week, multicenter, double-blind (DB), parallel-group, placebo-controlled study. Patients will be stratified based on whether they use concomitant estrogen/progestin therapy and then randomized in a 4:1 ration to receive either testosterone transdermal system (300 mcg/day) or placebo. Patients using estrogen/progestin at the start of the study should maintain this therapy throughout the study; patients not using estrogen/progestin at the start of the study should not initiate estrogen/progestin therapy throughout the study. Endometrial biopsies and transvaginal ultrasounds will be collected/performed at screening and study exit for all patients. Safety will be assessed by adverse events, reports of vaginal bleeding, lipids, serum chemistry, and hematology. Physical exams, pap smears, and mammograms will be monitored.
- Conditions
- Hypoactive Sexual Desire Disorder
- Being tested
- Testosterone Transdermal System, Placebo patch
- Keywords
- Natural Menopause
- 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 SystemDrug
Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
Placebo patchDrug
placebo patch, changed twice a week for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 28 cm² Placebo patch Receives: Drug: Placebo patch |
| Testosterone | Experimental | Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks Receives: Drug: Testosterone Transdermal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1
Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies
Measured: 52 weeks
Secondary outcomes (2)
Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1
Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies
Measured: 52 weeks
Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1
Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johna Lucas, MD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467259
- Sponsor's protocol ID
- 2007004
- Status last verified
- Nov 2011
- First submitted
- 27 Apr 2007
- Last updated
- 15 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-controlled, Multicenter, 52-week Study to Evaluate the Endometrial Safety of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder.
- ClinicalTrials.gov ID
- NCT00467259
- Acronym / sponsor ID
- 2007004
- Conditions
- Hypoactive Sexual Desire Disorder
- Keywords
- Natural Menopause
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,271 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 30 Apr 2007 (estimated)
- Results
- Posted 15 Dec 2011
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 endometrial safety of a testosterone patch as treatment for low libido in naturally postmenopausal women.
Detailed description
Naturally postmenopausal women with hypoactive sexual desire disorder (HSDD) will be randomized into a 52-week, multicenter, double-blind (DB), parallel-group, placebo-controlled study. Patients will be stratified based on whether they use concomitant estrogen/progestin therapy and then randomized in a 4:1 ration to receive either testosterone transdermal system (300 mcg/day) or placebo. Patients using estrogen/progestin at the start of the study should maintain this therapy throughout the study; patients not using estrogen/progestin at the start of the study should not initiate estrogen/progestin therapy throughout the study. Endometrial biopsies and transvaginal ultrasounds will be collected/performed at screening and study exit for all patients. Safety will be assessed by adverse events, reports of vaginal bleeding, lipids, serum chemistry, and hematology. Physical exams, pap smears, and mammograms will be monitored.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo patch28 cm² Placebo patch |
| Testosterone | Experimental | Drug: Testosterone Transdermal SystemTestosterone patch, 300 mcg/day, change patch twice a week for 52 weeks |
Who may qualify
- Ages
- 45 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 and must be at least one year post menopausal, 45-70 years old, in general good health, and may or may not be on hormone therapy, and must have low sexual desire which causes distress.
Key exclusion criteria (1 listed)
- Women will be screened for study participation and must not be using androgen therapy or have any medical, physical, psychological, or pharmacological condition that could make participation unsafe or confound the safety evaluation.
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 SystemTestosterone patch, 300 mcg/day, change patch twice a week for 52 weeks | Drug | Testosterone |
| Placebo patchplacebo patch, changed twice a week for 52 weeks | Drug | Placebo |
Primary outcome
Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1
Time frame: 52 weeks
Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies
2 secondary outcomes
Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1
Time frame: 52 weeks
Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Johna Lucas, MD study director
Procter and Gamble
115 sites 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 System in people with Hypoactive Sexual Desire Disorder, run by Warner Chilcott at 115 sites in United States.
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 15 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 115 sites in United States. 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?
Yes. Results are posted in the registry (first posted 15 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1 (time frame: 52 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 15 Dec 2011.