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This study is designed to evaluate the endometrial safety of a testosterone patch as treatment for low libido in naturally postmenopausal women.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 28 cm² Placebo patch |
|
| Testosterone | Experimental | Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone Transdermal System | Drug | Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johna Lucas, MD | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Facility | Birmingham | Alabama | 35209 | United States | ||
| Research Facility |
Randomized 1127 women not using concomitant estrogen & progestin (E&P) therapy. An additional 134 women using concomitant estrogen & progestin therapy were randomized. Subjects were stratified by using or not using E&P by site and then randomized 4:1 300 mcg/d TTS or placebo.
Screening began 14 May 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo patch |
| FG001 | Testosterone | Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo patch | Drug | placebo patch, changed twice a week for 52 weeks |
|
Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies |
| 52 weeks |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| Research Facility | Mobile | Alabama | 36617 | United States |
| Research Facility | Montgomery | Alabama | 36116 | United States |
| Test Facility | Chandler | Arizona | 85225 | United States |
| Study Facility | Peoria | Arizona | 85381 | United States |
| Research Facility | Phoenix | Arizona | 85015 | United States |
| Research Facility | Phoenix | Arizona | 85032 | United States |
| Research Facility | Scottsdale | Arizona | 85251 | United States |
| Research Site | Tucson | Arizona | 85712 | United States |
| Research Facility | Tucson | Arizona | 85715 | United States |
| Study Facility | Tuscon | Arizona | 85741 | United States |
| Site Facility | Jonesboro | Arkansas | 72401 | United States |
| Site Facility | Little Rock | Arkansas | 72223 | United States |
| Research Facility | Anaheim | California | 92805 | United States |
| Research Site | Berkeley | California | 94705 | United States |
| Research Facility | Palm Desert | California | 92260 | United States |
| Research Facility | Pasadena | California | 91106 | United States |
| Research Facility | San Diego | California | 92123 | United States |
| Research Facility | San Ramon | California | 94583 | United States |
| Test Facility | Santa Rosa | California | 95405 | United States |
| Site Facility | Upland | California | 91786 | United States |
| Research Facility | Vista | California | 92083 | United States |
| Site Facility | Vista | California | 92083 | United States |
| Site Facility | Westlake Village | California | 91361 | United States |
| Test Facility | Denver | Colorado | 80218 | United States |
| Research Facility | Longmont | Colorado | 80501 | United States |
| Test Facility | New London | Connecticut | 06320 | United States |
| Study Facility | Waterbury | Connecticut | 06708 | United States |
| Research Facility | Washington D.C. | District of Columbia | 20036 | United States |
| Research Facility | Boynton Beach | Florida | 33437 | United States |
| Site Facility | Clearwater | Florida | 33759 | United States |
| Site Facility | Daytona Beach | Florida | 32114 | United States |
| Research Facility | Gainesville | Florida | 32601 | United States |
| Research Site | Jacksonville | Florida | 32207 | United States |
| Site Facility | Jupiter | Florida | 33458 | United States |
| Test Facility | Miami | Florida | 33156 | United States |
| Research Facility | Pinellas Park | Florida | 33781 | United States |
| Research Facility | Plantation | Florida | 33324 | United States |
| Study Facility | South Miami | Florida | 33143 | United States |
| Research Site | Tampa | Florida | 33606 | United States |
| Test Facility | Vero Beach | Florida | 32960 | United States |
| Research Facility | West Palm Beach | Florida | 33409 | United States |
| Research Facility | Weston | Florida | 33326 | United States |
| Research Facility | Alpharetta | Georgia | 30005 | United States |
| Research Facility | Atlanta | Georgia | 30342 | United States |
| Site Facility | Decatur | Georgia | 30034 | United States |
| Site Facility | Douglasville | Georgia | 30134 | United States |
| Site Facility | Roswell | Georgia | 30075 | United States |
| Test Facility | Savannah | Georgia | 31405 | United States |
| Study Facility | Idaho Falls | Idaho | 83404 | United States |
| Test Facility | Champaign | Illinois | 61820 | United States |
| Test Facility | Chicago | Illinois | 60610 | United States |
| Test Facility | Indianapolis | Indiana | 46250 | United States |
| Research Facility | Overland Park | Kansas | 66202 | United States |
| Site Facility | Louisville | Kentucky | 40291 | United States |
| Study Facility | Baltimore | Maryland | 21229 | United States |
| Research Facility | Baltimore | Maryland | 21285-6815 | United States |
| Study Facility | Boston | Massachusetts | 02114 | United States |
| Research Facility | Bingham Farm | Michigan | 48025 | United States |
| Study Facility | Paw Paw | Michigan | 49079 | United States |
| Test Facility | Saginaw | Michigan | United States |
| Research Facility | Edina | Minnesota | 55435 | United States |
| Research Site | Jackson | Mississippi | 39216 | United States |
| Test Facility | St Louis | Missouri | 63141 | United States |
| Site Facility | Billings | Montana | 59102 | United States |
| Research Site | Omaha | Nebraska | 68124 | United States |
| Site Facility | Las Vegas | Nevada | 89146 | United States |
| Test Facility | Reno | Nevada | 89502 | United States |
| Test Facility | Moorestown | New Jersey | 08057 | United States |
| Research Facility | New York | New York | 10016 | United States |
| Test Facility | Raleigh | North Carolina | 27609 | United States |
| Site Facility | Winston-Salem | North Carolina | 27103 | United States |
| Study Facility | Winston-Salem | North Carolina | 27103 | United States |
| Research Facility | Beachwood | Ohio | 44122 | United States |
| Test Facility | Centerville | Ohio | 45459 | United States |
| Research Facility | Cincinnati | Ohio | 45219 | United States |
| Study Facility | Cincinnati | Ohio | 45249 | United States |
| Research Facility | Cincinnati | Ohio | 45267-0457 | United States |
| Research Site | Cleveland | Ohio | 44106 | United States |
| Site Facility | Cleveland | Ohio | 44122 | United States |
| Test Facility | Columbus | Ohio | 43212 | United States |
| Test Facility | Columbus | Ohio | 43231 | United States |
| Research Facility | Dayton | Ohio | 45409 | United States |
| Test Facility | Englewood | Ohio | 45322 | United States |
| Test Facility | Oklahoma City | Oklahoma | United States |
| Test Facility | Tulsa | Oklahoma | 74104 | United States |
| Site Facility | Eugene | Oregon | 97401 | United States |
| Research Facility | Philadelphia | Pennsylvania | 19114 | United States |
| Study Facility | Bristol | Tennessee | 37620 | United States |
| Research Facility | Chattanooga | Tennessee | 37404 | United States |
| Research Facility | Nashville | Tennessee | 37203 | United States |
| Site Facility | Austin | Texas | 78705 | United States |
| Research Facility | Carrolton | Texas | 75007 | United States |
| Site Facility | Corpus Christi | Texas | 78414 | United States |
| Research Facility | Dallas | Texas | 75231 | United States |
| Test Facility | Farmers Branch | Texas | 75234 | United States |
| Research Facility | Houston | Texas | 77030 | United States |
| Research Facility | Irving | Texas | 75061 | United States |
| Research Facility | Midland | Texas | 79705 | United States |
| Research Facility | Richardson | Texas | 75082 | United States |
| Site Facility | San Antonio | Texas | 78229 | United States |
| Test Facility | San Antonio | Texas | 78229 | United States |
| Study Facility | Salt Lake City | Utah | 84117 | United States |
| Research Facility | West Valley City | Utah | 84120 | United States |
| Research Facility | Newport News | Virginia | 23606 | United States |
| Study Facility | Richmond | Virginia | 23229 | United States |
| Test Facility | Richmond | Virginia | 23229 | United States |
| Site Facility | Richmond | Virginia | 23294 | United States |
| Research Facility | Virginia Beach | Virginia | 23452 | United States |
| Research Facility | Virginia Beach | Virginia | 23456 | United States |
| Site Facility | Seattle | Washington | 98105 | United States |
| Research Facility | Tacoma | Washington | 98405 | United States |
| Test Facility | Tacoma | Washington | 98405 | United States |
| Research Site | Charleston | West Virginia | 25301 | United States |
| ITT Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo patch |
| BG001 | Testosterone | Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | ITT Population | Mean | Standard Deviation | years |
| ||||||||||||||
| Age, Customized | ITT Population | Number | Participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | ITT Population | Number | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | ITT Population | Number | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Subjects with evaluable endometrial biopsies. | Posted | Number | 95% Confidence Interval | # Endometrial Hyperplasia/Evaluable Biop | 52 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Subjects with evaluable endometrial biopsies. | Posted | Number | 95% Confidence Interval | # Endometrial Hyperplasia/Evaluable Biop | 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Subjects with evaluable endometrial biopsies. | Posted | Number | 95% Confidence Interval | # Endometrial Hyperplasia/Evaluable Biop | 52 weeks |
|
|
52 week treatment period
Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo patch | 10 | 251 | 125 | 251 | ||
| EG001 | Testosterone | Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks | 33 | 1,019 | 472 | 1,019 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Artery Disease | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Congenital Cerebrovascular Anomaly | Congenital, familial and genetic disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Oesophageal Spasm | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Small Intestine Haemorrhage | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Appendicitis Perforated | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Joint Abscess | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Sternal Injury | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Radius Fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Ulna Fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Arthritis Reactive | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Breast Cancer in Situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Hodgkin's Disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Leiomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Leiomyosarcoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Colon Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Metastases to Liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Brain Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Acoustic Neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Oesophageal Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Guillain-Barre Syndrome | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Carotid Artery Occlusion | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypertensive Encephalopathy | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Affective Disorder | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Stress Urinary Incontinence | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Glomerulonephritis Minimal Lesion | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Uterine Prolapse | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Application Site Reaction | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hirsutism | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grexan Wulff, Manager Regulatory Affairs | Warner Chilcott | 973-442-3376 | gwulff@wcrx.com |
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
| 50-59 years old |
|
| 60-65 years old |
|
| 66 + years old |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian (Oriental) |
|
| Black or African American |
|
| Caucasian |
|
| Hispanic |
|
| Indian (Asian) |
|
| Latino |
|
| Mexican |
|
| Multi-Racial |
|
| Hawaiian / Pacific Islander |
|
| Spanish |
|
|
|
|
|