Contraception
Conditions
Keywords
Contraception, Male Contraception, Suppression of Sperm Production
Brief summary
To determine the number of men who have suppression of sperm production when using a daily regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel applied transdermally.
Interventions
DRUGTestosterone
Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
DRUGNestorone®
Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head.
Sponsors
Population Council
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Premier Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Men who meet all the following criteria are eligible for enrollment in the trial: 1. Male volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening 2. 18 to 50 years of age 3. BMI ≤ 33 calculated as weight in Kg/ (height in cm) 2 4. No history of hormonal therapy use in the last six months prior to the first screening visit 5. Subject will agree to use a recognized effective method of contraception with his partner (i.e. at a minimum, use double-barrier contraception) during the course of the study treatment and recovery phase 6. In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form 7. Does not meet any of the
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Number of Men Who Have Suppression of Sperm Production ≤1Million/mL Million/mL When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel Applied Transdermally. | 24 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| The Number of Men Who Have Suppression of Sperm Production ≤3 Million/mL ≤ 3 Million/mL or Azoospermia When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel. | 24 Weeks |
| The Number of Men Who Have Azoospermia | 24 Weeks |
| The Impact on Sperm Motility in Men Who Are Not Azoospermic Azoospermic. | 24 Weeks |
| The Impact on Sperm Morphology in Men Who Are Not Azoospermic | 24 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Testosterone Gel 10 g and Nestorone® 0 mg Per Day Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head. | 32 |
| Testosterone Gel 10 g and Nestorone® 8 mg Per Day Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head. | 33 |
| Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head. | 34 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 3 |
| Overall Study | Lost to Follow-up | 4 | 4 | 5 |
| Overall Study | Physician Decision | 2 | 1 | 0 |
| Overall Study | Pregnancy | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 3 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 4 | 5 |
Baseline characteristics
| Characteristic | Testosterone Gel 10 g and Nestorone® 0 mg Per Day | Testosterone Gel 10 g and Nestorone® 8 mg Per Day | Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 33 Participants | 34 Participants | 99 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 9 Participants | 10 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 24 Participants | 24 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 1 Participants | 1 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 3 Participants | 7 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) White | 16 Participants | 24 Participants | 25 Participants | 65 Participants |
| Region of Enrollment United States | 32 participants | 33 participants | 34 participants | 99 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 32 Participants | 33 Participants | 34 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 22 / 32 | 23 / 33 | 24 / 34 |
| serious Total, serious adverse events | 0 / 32 | 0 / 33 | 0 / 34 |
Outcome results
Primary
The Number of Men Who Have Suppression of Sperm Production ≤1Million/mL Million/mL When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel Applied Transdermally.
Time frame: 24 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Testosterone Gel 10 g and Nestorone® 0 mg Per Day | The Number of Men Who Have Suppression of Sperm Production ≤1Million/mL Million/mL When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel Applied Transdermally. | 5 participants |
| Testosterone Gel 10 g and Nestorone® 8 mg Per Day | The Number of Men Who Have Suppression of Sperm Production ≤1Million/mL Million/mL When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel Applied Transdermally. | 15 participants |
| Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day | The Number of Men Who Have Suppression of Sperm Production ≤1Million/mL Million/mL When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel Applied Transdermally. | 13 participants |
Secondary
The Impact on Sperm Morphology in Men Who Are Not Azoospermic
Time frame: 24 weeks
Population: Only subjects with the appropriate amount of data for measurement are represented in the outcome measure data table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Gel 10 g and Nestorone® 0 mg Per Day | The Impact on Sperm Morphology in Men Who Are Not Azoospermic | 12.3 percentage normal morphology | Standard Deviation 3.87 |
| Testosterone Gel 10 g and Nestorone® 8 mg Per Day | The Impact on Sperm Morphology in Men Who Are Not Azoospermic | 10.8 percentage normal morphology | Standard Deviation 4.83 |
| Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day | The Impact on Sperm Morphology in Men Who Are Not Azoospermic | 9.1 percentage normal morphology | Standard Deviation 4.64 |
Secondary
The Impact on Sperm Motility in Men Who Are Not Azoospermic Azoospermic.
Time frame: 24 Weeks
Population: Only subjects with the appropriate amount of data for measurement are represented in the outcome measure data table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testosterone Gel 10 g and Nestorone® 0 mg Per Day | The Impact on Sperm Motility in Men Who Are Not Azoospermic Azoospermic. | Percent Progressive (week 24) | 52.8 percentage of sperm | Standard Deviation 10.7 |
| Testosterone Gel 10 g and Nestorone® 0 mg Per Day | The Impact on Sperm Motility in Men Who Are Not Azoospermic Azoospermic. | Percent Non Progressive (week 24) | 10.4 percentage of sperm | Standard Deviation 10.72 |
| Testosterone Gel 10 g and Nestorone® 8 mg Per Day | The Impact on Sperm Motility in Men Who Are Not Azoospermic Azoospermic. | Percent Progressive (week 24) | 31.9 percentage of sperm | Standard Deviation 26.89 |
| Testosterone Gel 10 g and Nestorone® 8 mg Per Day | The Impact on Sperm Motility in Men Who Are Not Azoospermic Azoospermic. | Percent Non Progressive (week 24) | 7.4 percentage of sperm | Standard Deviation 11.94 |
| Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day | The Impact on Sperm Motility in Men Who Are Not Azoospermic Azoospermic. | Percent Non Progressive (week 24) | 8.3 percentage of sperm | Standard Deviation 4.82 |
| Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day | The Impact on Sperm Motility in Men Who Are Not Azoospermic Azoospermic. | Percent Progressive (week 24) | 29.6 percentage of sperm | Standard Deviation 17.15 |
Secondary
The Number of Men Who Have Azoospermia
Time frame: 24 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Testosterone Gel 10 g and Nestorone® 0 mg Per Day | The Number of Men Who Have Azoospermia | 5 participants |
| Testosterone Gel 10 g and Nestorone® 8 mg Per Day | The Number of Men Who Have Azoospermia | 14 participants |
| Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day | The Number of Men Who Have Azoospermia | 11 participants |
Secondary
The Number of Men Who Have Suppression of Sperm Production ≤3 Million/mL ≤ 3 Million/mL or Azoospermia When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel.
Time frame: 24 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Testosterone Gel 10 g and Nestorone® 0 mg Per Day | The Number of Men Who Have Suppression of Sperm Production ≤3 Million/mL ≤ 3 Million/mL or Azoospermia When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel. | 5 participants |
| Testosterone Gel 10 g and Nestorone® 8 mg Per Day | The Number of Men Who Have Suppression of Sperm Production ≤3 Million/mL ≤ 3 Million/mL or Azoospermia When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel. | 15 participants |
| Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day | The Number of Men Who Have Suppression of Sperm Production ≤3 Million/mL ≤ 3 Million/mL or Azoospermia When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel. | 14 participants |