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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This is a prospective, randomized, double-blinded, two-center trial to evaluate the gonadotropin suppressive activity of transdermal treatment with a combined NES/T gel, or T gel alone, for 28 days.
A total of 45 subjects will be enrolled and randomized in a 2:1 ratio to one of two treatment groups. A description of each group is as follows:
The total duration of treatment will be 28 days followed by a 72 hour sampling period to assess half-life and a recovery period of at least 28 days, at which point the subjects will return to the clinic for an end of study visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders |
|
| Group 2 | Experimental | 4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nestorone® /testosterone gel | Drug | Nestorone® /testosterone combined gel |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Gonadotropin Suppression | To quantify the gonadotropin suppressive activity of 4 weeks daily therapy of a combination transdermal gel containing 8.3 mg Nestorone® (NES) gel and 62.5 mg (1.62%) testosterone (T) gel, and of T gel (1.62%) alone. Specifically, the proportion (and 95% CI) of men who suppress both gonadotropins (luteinizing hormone [LH] and follicle-stimulating hormone [FSH]) to ≤ 1 IU/L in each group, will be quantified. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gonadotropin and Follicle-stimulating Hormone Suppression | • To quantify the proportion (and 95% CI) of men who suppress both gonadotropins (luteinizing hormone [LH] and follicle-stimulating hormone [FSH]) to the detection limit of the assay in each group. | 4 weeks |
| Change in LH and FSH Concentrations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Wang, MD | Research Site | Principal Investigator |
| William Bremner, MD | Research Site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LA Biomedical Research Institute | Torrance | California | 90502 | United States | ||
| University of Washington |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | 5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders Nestorone® /testosterone gel: Nestorone® /testosterone combined gel |
| FG001 | Group 2 | 4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders Testosterone only gel: Testosterone only gel |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | 5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders Nestorone® /testosterone gel: Nestorone® /testosterone combined gel |
| BG001 | Group 2 |
| 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 |
| 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 | Gonadotropin Suppression | To quantify the gonadotropin suppressive activity of 4 weeks daily therapy of a combination transdermal gel containing 8.3 mg Nestorone® (NES) gel and 62.5 mg (1.62%) testosterone (T) gel, and of T gel (1.62%) alone. Specifically, the proportion (and 95% CI) of men who suppress both gonadotropins (luteinizing hormone [LH] and follicle-stimulating hormone [FSH]) to ≤ 1 IU/L in each group, will be quantified. | Posted | Count of Participants | Participants | 4 weeks |
|
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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 | Group 1 | 5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders Nestorone® /testosterone gel: Nestorone® /testosterone combined gel |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHEA | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Myer | Health Decisions | 9842381297 | Kimberly.Myer@premier-research.com |
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| ID | Term |
|---|---|
| C029167 | ST 1435 |
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Testosterone only gel |
| Drug |
Testosterone only gel |
|
|
• To quantify the median percent change from baseline to week 4 and interquartile range for serum gonadotropins (LH and FSH) concentrations for each treatment group. |
| 4 weeks |
| Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations. | A simple acceptability questionnaire used previously in male CCTN studies was administered at treatment Day 28 (28, 29) for subjects to answer questions about the acceptability of gel as a product and as a method for contraception over the preceding 4 weeks. | 4 weeks |
| T Serum Concentrations | 8 weeks |
| Secondary Outcome # 6 Part 1a: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hemoglobin) | General composite safety as measured various times during the study by CBC-Hemoglobin | 4 weeks |
| Assessing Sexual Function by Compare Gonadotropin Suppressive Activity of T and NES Against T Alone Through the Psychosexual Daily Questionnaire. | Sexual activity was rated on a scale from 0 (not at all) to 7 (very high enjoyment/pleasure). Erections were rated on a scale of 0 (not satisfactory) to 7 (very satisfactory). Results are change from baseline to final treatment evaluation. | 4 weeks |
| Secondary Outcome # 6 Part 2a: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry | Change from baseline to final treatment evaluation-Total Cholesterol, Triglycerides, HDL | 4 weeks |
| Secondary Outcome # 6 Part 3a: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Blood Pressure) | Change from baseline to final treatment evaluation | 4 weeks |
| Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | Change from baseline to final treatment evaluation | 4 weeks |
| Secondary Outcome # 6 Part 5: A Composite Safety of the Combined Gel Determined by Outcomes of Psychosexual Questionnaires | Change from baseline to final treatment evaluation. Sexual motivation was rated on a scale of 0 (none) to 7 (very high). Erections were rated on a scale of 0 (not satisfactory) to 7 (very satisfactory). | 4 weeks |
| Secondary Outcome # 6 Part 3: A Composite Safety of the Combined Gel Determined by Outcomes of Patient Health Questionnaires | PHQ-9 Total Score: Change from baseline to final treatment evaluation. The Patient Health Questionnaire (PHQ)-9 is a self-administered instrument for screening, monitoring and diagnosis of depression. This questionnaire can be used repeatedly to monitor improvement or worsening of symptoms. Scale range is from 0 (not at all) to 3 (nearly every day). | 4 weeks |
| NES Serum Concentrations | 8 weeks |
| Secondary Outcome # 6 Part 1b: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (WBC) | General composite safety as measured various times during the study by CBC - WBC | 4 weeks |
| Secondary Outcome # 6 Part 1c: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hematocrit) | General composite safety as measured various times during the study by CBC-Hematocrit | 4 weeks |
| Secondary Outcome # 6 Part 2b: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry | Change from baseline to final treatment evaluation-ALT, AST | 4 weeks |
| Secondary Outcome # 6 Part 3b: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Weight) | Change from baseline to final treatment evaluation | 4 weeks |
| Seattle |
| Washington |
| 98195 |
| United States |
4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders
Testosterone only gel: Testosterone only gel
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders
Testosterone only gel: Testosterone only gel
|
|
|
| Secondary | Gonadotropin and Follicle-stimulating Hormone Suppression | • To quantify the proportion (and 95% CI) of men who suppress both gonadotropins (luteinizing hormone [LH] and follicle-stimulating hormone [FSH]) to the detection limit of the assay in each group. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Secondary | Change in LH and FSH Concentrations | • To quantify the median percent change from baseline to week 4 and interquartile range for serum gonadotropins (LH and FSH) concentrations for each treatment group. | Posted | Median | Standard Deviation | IU/L | 4 weeks |
|
|
|
| Secondary | Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations. | A simple acceptability questionnaire used previously in male CCTN studies was administered at treatment Day 28 (28, 29) for subjects to answer questions about the acceptability of gel as a product and as a method for contraception over the preceding 4 weeks. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Secondary | T Serum Concentrations | The difference in numbers means there was missing data | Posted | Mean | Standard Deviation | ng/dL | 8 weeks |
|
|
|
| Secondary | Secondary Outcome # 6 Part 1a: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hemoglobin) | General composite safety as measured various times during the study by CBC-Hemoglobin | Posted | Mean | Standard Deviation | g/dl | 4 weeks |
|
|
|
| Secondary | Assessing Sexual Function by Compare Gonadotropin Suppressive Activity of T and NES Against T Alone Through the Psychosexual Daily Questionnaire. | Sexual activity was rated on a scale from 0 (not at all) to 7 (very high enjoyment/pleasure). Erections were rated on a scale of 0 (not satisfactory) to 7 (very satisfactory). Results are change from baseline to final treatment evaluation. | The difference in numbers means there was missing data in the questionnaire which caused some of the domains to have missing results while some domains could have a score calculated. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
|
|
| Secondary | Secondary Outcome # 6 Part 2a: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry | Change from baseline to final treatment evaluation-Total Cholesterol, Triglycerides, HDL | Posted | Mean | Standard Deviation | mg/dL | 4 weeks |
|
|
|
| Secondary | Secondary Outcome # 6 Part 3a: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Blood Pressure) | Change from baseline to final treatment evaluation | The difference in numbers means there was missing data. | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
|
|
|
| Secondary | Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes | Change from baseline to final treatment evaluation | The difference in numbers means there was missing data. | Posted | Number | participants | 4 weeks |
|
|
|
| Secondary | Secondary Outcome # 6 Part 5: A Composite Safety of the Combined Gel Determined by Outcomes of Psychosexual Questionnaires | Change from baseline to final treatment evaluation. Sexual motivation was rated on a scale of 0 (none) to 7 (very high). Erections were rated on a scale of 0 (not satisfactory) to 7 (very satisfactory). | The difference in numbers means there was missing data in the questionnaire which caused some of the domains to have missing results while some domains could have a score calculated. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
|
|
| Secondary | Secondary Outcome # 6 Part 3: A Composite Safety of the Combined Gel Determined by Outcomes of Patient Health Questionnaires | PHQ-9 Total Score: Change from baseline to final treatment evaluation. The Patient Health Questionnaire (PHQ)-9 is a self-administered instrument for screening, monitoring and diagnosis of depression. This questionnaire can be used repeatedly to monitor improvement or worsening of symptoms. Scale range is from 0 (not at all) to 3 (nearly every day). | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
|
|
| Secondary | NES Serum Concentrations | The difference in numbers means there was missing data | Posted | Mean | Standard Deviation | pmol/L | 8 weeks |
|
|
|
| Secondary | Secondary Outcome # 6 Part 1b: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (WBC) | General composite safety as measured various times during the study by CBC - WBC | Posted | Mean | Standard Deviation | WBCs per microliter | 4 weeks |
|
|
|
| Secondary | Secondary Outcome # 6 Part 1c: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hematocrit) | General composite safety as measured various times during the study by CBC-Hematocrit | Posted | Mean | Standard Deviation | percentage of blood | 4 weeks |
|
|
|
| Secondary | Secondary Outcome # 6 Part 2b: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry | Change from baseline to final treatment evaluation-ALT, AST | Posted | Mean | Standard Deviation | IU/L | 4 weeks |
|
|
|
| Secondary | Secondary Outcome # 6 Part 3b: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Weight) | Change from baseline to final treatment evaluation | The difference in numbers means there was missing data. | Posted | Mean | Standard Deviation | lbs | 4 weeks |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 10 |
| 29 |
| EG001 | Group 2 | 4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders Testosterone only gel: Testosterone only gel | 0 | 15 | 0 | 15 | 5 | 15 |
| VOMITING | Gastrointestinal disorders |
|
| APPLICATION SITE RASH | General disorders |
|
| HYPERSENSITIVITY | Immune system disorders |
|
| LOCALIZED INFECTION | Infections and infestations |
|
| EXCORIATION | Injury, poisoning and procedural complications |
|
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications |
|
| Periorbital contusion | Injury, poisoning and procedural complications |
|
| SUNBURN | Injury, poisoning and procedural complications |
|
| THERMAL BURN | Injury, poisoning and procedural complications |
|
| Eosinophil count increased | Investigations |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders |
|
| PAIN IN EXTREMITY | Metabolism and nutrition disorders |
|
| CONVULSION | Nervous system disorders |
|
| HEADACE | Nervous system disorders |
|
| SYNCOPE | Nervous system disorders |
|
| LIBIDO DECREASED | Psychiatric disorders |
|
| Varicocele | Reproductive system and breast disorders |
|
| DRY SKIN | Skin and subcutaneous tissue disorders |
|
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| Overall satisfaction: undecided |
|
| Overall satisfaction: agree |
|
| Overall satisfaction: Strongly agree |
|
| Testosterone Day 28: 0 minutes pre-dose |
|
|
| Testosterone Day 56 (recovery) |
|
|
| Erections |
|
|
| HDL |
|
| Skin: No Change |
|
|
| Skin: Worsened |
|
|
| Heart: Improved |
|
|
| Heart: No Change |
|
|
| Heart: Worsened |
|
|
| Digital Rectal Exam: Improved |
|
|
| Digital Rectal Exam: No Change |
|
|
| Digital Rectal Exam: Worsened |
|
|
| Erections: Change from baseline to final treatment |
|
|
| Nesterone Day 28: 0 minutes pre-dose |
|
|
| Nesterone Day 56 (recovery) |
|
|