Daily Nestorone (NES) and Testosterone (T) Combination Gel for Male Contraception
Objective: To determine whether the daily application of a gel containing NES and T is safe, acceptable, reversible, and effective for sperm suppression and pregnancy prevention over the course of 1 year.
DURATION OF THE STUDY: Approximately 2 years
Screening period: 56 days
Suppression phase: up to 20 weeks
Contraceptive phase: 12 months
Recovery period: up to 6 months
Regimen: Each day, participants will apply 2.5 mL of contraceptive gel to each shoulder and upper arm (total of 5mL). Each application includes 62mg of T (6mg absorbed) and 8mg of NES (0.8mg absorbed). Participants are expected to apply the gel after showering in the morning, and to leave the gel on the skin for at least 4 hours thereafter before washing.
Inclusion Criteria (Male Partner): BMI <33 kg/m2, willingness to abide by the protocol, commitment to a monogamous relationship for at least a year, normal sperm count (<15 million/mL in two semen samples).
Inclusion Criteria (Female Partner): Regular menstrual cycles when not using hormonal contraceptives, intact uterus and ovaries, and no knowledge of infertility.
Screening Phase: The screening phase consists of two study visits. During these visits a medical history will be obtained, physical exams completed, and both serum lab and semen testing performed to determine eligibility.
Suppression Phase: If couples meet the criteria for the study, they will return be enrolled into the suppression phase where the male partner will begin using the gel. During this phase, the couple must use an additional form of contraception while applying the gel daily to prevent pregnancies while the sperm count is being suppressed. Participants are expected to come to the site every other week during this phase.
Efficacy Phase: After sperm concentration is reduced to the desired level, participants will enter the efficacy phase. During this period, participants will continue to apply the gel so that sperm concentrations are maintained at a level of 1 million/mL or less. Couples will stop using other forms of contraception and will only depend on the gel for pregnancy prevention. Participants are expected to come to the site every month during this phase to obtain the gel, screen for side effects, provide blood for labs, and to confirm continued suppression of sperm production.
Recovery Phase: Once the efficacy phase is complete, participants will stop using the combination gel and will be evaluated for recovery of their sperm counts. This phase will end once the sperm count has reached at least 15 million/mL, measured over two semen samples, and with confirmation of no abnormalities of the sperm’s motility (movement) or morphology (structure).
Compensation: Male participants will be paid up to $2,600 for study completion and female participant up to $840 to complete the study.