| Primary | Changes From Baseline (Cavg) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel | Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cavg after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman. | includes female participants that completed the skin contact types | Posted | | Mean | Standard Deviation | ng/dL | | Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt) | | | | ID | Title | Description |
|---|
| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
| | | Title | Denominators | Categories |
|---|
| Baseline | | | | With T-shirt Clothing Barrier | |
| |
| Secondary | PK of T in Males After NES/T With a T-shirt and After Washing | PK of testosterone in males after wearing a T shirt and after washing will be compared to serum testosterone PK after application of the combined gel without washing using AUC (0-t, where t is the last time-point with measurable concentration) | Subjects that had measurements at the respective timepoints were included | Posted | | Mean | Standard Deviation | ng/dL | | Baseline and 24 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt) | | | | ID | Title | Description |
|---|
| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
|
| Secondary | PK of NES in Males After NES/T With a T-shirt and After Washing | PK of Nestorone in males after wearing a T shirt and after washing will be compared to serum Nestorone PK after application of the combined gel without washing using AUC (0-t, where t is the last time-point with measurable concentration) | Subjects that had measurements at the respective timepoints were included | Posted | | Mean | Standard Deviation | pg/dL | | Baseline and 24 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt) | | | | ID | Title | Description |
|---|
| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
|
| Secondary | Average Testosterone Levels 90 and 150 Minutes After Each Application in Men | Average testosterone levels 90 and 150 minutes after each application in men (over a 15 day period) as measured by adhesive D-square strips with showering (Visit 5) and without showering (Visit 7). | Subjects that had measurements at the respective timepoints were analyzed | Posted | | Mean | Standard Deviation | T (microg) | | Visits 5 and 7 (Days 8 and 15) | | | | ID | Title | Description |
|---|
| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
|
| Secondary | Average Nestorone Levels 90 and 150 Minutes After Each Application in Men | Average Nestorone levels 90 and 150 minutes after each application in men (over a 15 day period) as measured by adhesive D-square strips with showering (Visit 5) and without showering (Visit 7). | Subjects that had measurements at the respective timepoints were analyzed | Posted | | Mean | Standard Deviation | NES (microg) | | Visits 5 and 7 (Days 8 and 15) | | | | ID | Title | Description |
|---|
| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
|
| Secondary | Incidence of Adverse Events and Serious Adverse Events for Males | | | Posted | | Count of Participants | | Participants | | 31 days | | | | ID | Title | Description |
|---|
| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
| |
| Secondary | Incidence of Adverse Events and Serious Adverse Events for Females | | | Posted | | Count of Participants | | Participants | | 31 days | | | | ID | Title | Description |
|---|
| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
| |
| Secondary | Changes From Baseline in Hematology Safety Labs for Females | Changes from baseline in hematology parameters for females measured at Screening (Day -28 to 0) and Visit 7 (Day 15) | only includes subjects who had both baseline and at least on post-baseline non-missing data | Posted | | Mean | Standard Deviation | 10^3 cells/uL | | Screening and Visit 7, up to 43 days | | | | ID | Title | Description |
|---|
| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
| |
| Primary | Changes From Baseline (Cmin) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel | Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cmin after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman. | includes female participants that completed the skin contact types | Posted | | Mean | Standard Deviation | ng/dL | | Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt) | | | | ID | Title | Description |
|---|
| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
|
| Primary | Changes From Baseline (Cmax) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel | Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cmax after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman. | includes female participants that completed the skin contact types | Posted | | Mean | Standard Deviation | ng/dL | | Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt) | | | | ID | Title | Description |
|---|
| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
|
| Primary | Changes From Baseline (Cmin) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel | Evaluate in female participants by assessing changes from baseline up to 48 hours for serum Nestorone levels in Cmin after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman. | includes female participants that had measurements at the specified timepoints | Posted | | Mean | Standard Deviation | pg/dL | | Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt) | | | | ID | Title | Description |
|---|
| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
|
| Primary | Changes From Baseline (Cmax) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel | Evaluate in female participants by assessing changes from baseline up to 48 hours for serum Nestorone levels in Cmax after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman. | includes female participants that had measurements at the specified timepoints | Posted | | Mean | Standard Deviation | pg/dL | | Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt) | | | | ID | Title | Description |
|---|
| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
|
| Primary | Changes From Baseline (Cavg) for Serum Nestorone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel | Evaluate in female participants by assessing changes from baseline up to 48 hours for serum Nestorone levels in Cavg after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman. | includes female participants that had measurements at the specified timepoints | Posted | | Mean | Standard Deviation | pg/dL | | Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt) | | | | ID | Title | Description |
|---|
| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
|
| Secondary | Changes From Baseline in Hematology Safety Labs for Males | Changes from baseline in hematology parameters for males measured at Screening (Day -28 to 0) and Visit 7 (Day 15) | only includes subjects who had both baseline and at least one post-baseline non-missing data | Posted | | Mean | Standard Deviation | 10^3 cells/uL | | Screening and Visit 7, up to 43 days | | | | ID | Title | Description |
|---|
| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
| |
| Secondary | Changes From Baseline in Hematology Safety Labs for Females | Changes from baseline in hematology parameters for females measured at Screening (Day -28 to 0) and Visit 7 (Day 15) | only includes subjects who had both baseline and at least one post-baseline non-missing data | Posted | | Mean | Standard Deviation | g/L | | Screening and Visit 7, up to 43 days | | | | ID | Title | Description |
|---|
| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
| |
| Secondary | Changes From Baseline in Hematology Safety Labs for Males | Changes from baseline in hematology parameters for males measured at Screening (Day -28 to 0) and Visit 7 (Day 15) | only includes subjects who had both baseline and at least one post-baseline non-missing data | Posted | | Mean | Standard Deviation | g/L | | Screening and Visit 7, up to 43 days | | | | ID | Title | Description |
|---|
| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
| |
| Secondary | Changes From Baseline in Clinical Chemistry Safety Labs for Females | Changes from baseline in clinical chemistry parameters for females measured at Screening (Day -28 to 0) and Visit 7 (Day 15) | only includes subjects who had both baseline and at least one post-baseline non-missing data | Posted | | Mean | Standard Deviation | U/L | | Screening and Visit 7, up to 43 days | | | | ID | Title | Description |
|---|
| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
| |
| Secondary | Changes From Baseline in Clinical Chemistry Safety Labs for Males | Changes from baseline in clinical chemistry parameters for males measured at Screening (Day -28 to 0) and Visit 7 (Day 15) | only includes subjects who had both baseline and at least one post-baseline non-missing data | Posted | | Mean | Standard Deviation | U/L | | Screening and Visit 7, up to 43 days | | | | ID | Title | Description |
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| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
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| Secondary | Changes From Baseline in Clinical Chemistry Safety Labs for Females | Changes from baseline in clinical chemistry parameters for females measured at Screening (Day -28 to 0) and Visit 7 (Day 15) | only includes subjects who had both baseline and at least one post-baseline non-missing data | Posted | | Mean | Standard Deviation | g/L | | Screening and Visit 7, up to 43 days | | | | ID | Title | Description |
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| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
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| Secondary | Changes From Baseline in Clinical Chemistry Safety Labs for Males | Changes from baseline in clinical chemistry parameters for males measured at Screening (Day -28 to 0) and Visit 7 (Day 15) | only includes subjects who had both baseline and at least one post-baseline non-missing data | Posted | | Mean | Standard Deviation | g/L | | Screening and Visit 7, up to 43 days | | | | ID | Title | Description |
|---|
| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
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| Secondary | Changes From Baseline in Clinical Chemistry Safety Labs for Females | Changes from baseline in clinical chemistry parameters for females measured at Screening (Day -28 to 0) and Visit 7 (Day 15) | only includes subjects who had both baseline and at least one post-baseline non-missing data | Posted | | Mean | Standard Deviation | mmol/L | | Screening and Visit 7, up to 43 days | | | | ID | Title | Description |
|---|
| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
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| Secondary | Changes From Baseline in Clinical Chemistry Safety Labs for Males | Changes from baseline in clinical chemistry parameters for males measured at Screening (Day -28 to 0) and Visit 7 (Day 15) | only includes subjects who had both baseline and at least one post-baseline non-missing data | Posted | | Mean | Standard Deviation | mmol/L | | Screening and Visit 7, up to 43 days | | | | ID | Title | Description |
|---|
| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
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| Secondary | Percentage of Females With Increased (Relative to Baseline) Hirsutism at Each Visit. | Female hirsutism changes assessed at Screening, Visits 4, 6, 8, and 9 | females that were assessed are included | Posted | | Count of Participants | | Participants | | Screening, Visit 4 (Day 3), Visit 6 (Day 10), Visit 8 (Day 17), and Visit 9 (Day 31) | | | | ID | Title | Description |
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| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
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| Secondary | Percentage of Females With Increased (Relative to Baseline) Acne at Each Visit. | Female acne changes assessed at Screening, Visits 4, 6, 8, and 9 | subjects that had assessments completed at the respective visits were included | Posted | | Count of Participants | | Participants | | Screening, Visit 4 (Day 3), Visit 6 (Day 10), Visit 8 (Day 17), and Visit 9 (Day 31) | | | | ID | Title | Description |
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| OG000 | Nestorone (NES) + Testosterone (T) Combined Gel | A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel) in 5 ml of combined gel. Nestorone + Testosterone Combination Gel: The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel). |
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