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The purpose of this study is to compare how subjects feel after receiving injections of two different types of GnRH six months apart. One injection is given under the skin of the abdomen, and the other one into the muscle of the buttock or thigh.
GnRH is given as an injection. Injections of GnRH can be uncomfortable, causing a feeling of burning or stinging. The uncomfortable feeling may be caused by differences in the types of GnRH and the site of the injection (under the skin of the abdomen, or into the muscle of the buttock or thigh).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leuprolide acetate | Active Comparator | Polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) injected subcutaneously in upper or mid-abdominal area. Injection occurred either 6 months before or 6 months after injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock. |
|
| Triptorelin pamoate | Active Comparator | Triptorelin pamoate suspension (Trelstar 22.5 mg) injected intramuscularly in the buttock. Injection occurred either 6 months before or 6 months after injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) subcutaneously in upper or mid-abdominal area. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptorelin pamoate | Drug | Triptorelin pamoate for injectable suspension 22.5 mg administered as a single intramuscular injection in either buttock |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Bother From Injection Site Burning and/or Stinging | Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Discomfort From Injection | Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection | 15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marilyn McIlwain, BS | Watson Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Watson Investigational Site | Homewood | Alabama | United States | |||
| Watson Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24354113 | Derived | Shore ND, Sieber P, Schimke L, Perzin A, Olsen S. Comparison of tolerability and adverse events following treatment with two GnRH agonists in patients with advanced prostate cancer. Urol Nurs. 2013 Sep-Oct;33(5):236-44, 248. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Triptorelin First, Then Leuprolide Acetate | Injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock, followed 6 months later by injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) in the upper or mid-abdominal area. A detailed breakdown of participant flow by treatment period for each arm is not available. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Leuprolide acetate | Drug | Leuprolide acetate for injectable suspension 45 mg administered as a single subcutaneous injection in the upper- or mid-abdominal area. |
|
| Daytona Beach |
| Florida |
| United States |
| Watson Investigational Site | Orange City | Florida | United States |
| Watson Investigational Site | Coeur d'Alene | Idaho | United States |
| Watson Investigational Site | Carmel | Indiana | United States |
| Watson Investigational Site | Jeffersonville | Indiana | United States |
| Watson Investigational Site | Shreveport | Louisiana | United States |
| Watson Investigational Site | Las Vegas | Nevada | United States |
| Watson Investigational Site | Mount Laurel | New Jersey | United States |
| Watson Investigational Site | Voorhees Township | New Jersey | United States |
| Watson Investigational Site | Albany | New York | United States |
| Watson Investigational Site | Syracuse | New York | United States |
| Watson Investigational Site | Lancaster | Pennsylvania | United States |
| Watson Investigational Site | Myrtle Beach | South Carolina | United States |
| Watson Investigational Site | Dallas | Texas | United States |
| Watson Investigational Site | Norfolk | Virginia | United States |
| FG001 | Leuprolide Acetate First, Then Triptorelin | Injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) in the upper or mid-abdominal area, followed 6 months later by injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock. A detailed breakdown of participant flow by treatment period for each arm is not available. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Leuprolide Acetate First, Then Triptorelin | Polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) injected subcutaneously in upper or mid-abdominal area 6 months before injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock. |
| BG001 | Triptorelin First, Then Leuprolide Acetate | Triptorelin pamoate suspension (Trelstar 22.5 mg) injected intramuscularly in the buttock 6 months before injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) subcutaneously in upper or mid-abdominal area. |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Patient Bother From Injection Site Burning and/or Stinging | Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection | Per-protocol population, defined as all patients who receive both study drugs and complete both post-injection questionnaires. | Posted | Mean | 95% Confidence Interval | units on a scale | 15 minutes |
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| Secondary | Discomfort From Injection | Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection | Per-protocol population, defined as all subjects who receive both study drugs and complete both post-injection questionnaires. | Posted | Mean | 95% Confidence Interval | units on a scale | 15 minutes |
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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 | Leuprolide Acetate | 0 | 118 | 0 | 118 | |||
| EG001 | Triptorelin Pamoate | 0 | 118 | 0 | 118 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Hoel, RPh, PhD, Vice President, Global Brand Clinical Research | Watson Laboratories, Inc. | 801-588-6641 | gary.hoel@watson.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D017329 | Triptorelin Pamoate |
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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| >=65 years |
|
| Male |
|
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