In vivo contraceptive trials protocol

eagle-i ID

Resource Type

Properties

1. Resource Description

   In vivo contraceptive trials – female The Nonhuman Primate Contraceptive Core (NPCC) provides services and coordination of animal usage for U54 Contraceptive Center investigators with approved projects. The NPCC maintains a pool of cynomolgus macaque females and males in the Division of Animal Resources (DAR), ONPR, available for contraceptive (mating) trials; coordinates and performs studies on potential contraceptive agents; confirms menstruation and ensures mating has occurred by taking vaginal swabs; performs ultrasounds to monitor for pregnancies; and obtains blood samples for hormone assays, pharmacokinetic studies and metabolic profiles. The Core acclimates the females to a small group (harem) housing situation (8-10 females to one male) wherein they can be separated for daily vaginal checks, dosing, blood sampling and ultrasound analyses. The NPCC is uniquely poised to drive proof-of-concept studies in nonhuman primates that can be readily translated into further efforts to test novel contraceptives in women. The final stage in the strategy to discover novel agents for female fertility regulation will be to evaluate the efficacy of these agents as reversible contraceptive agents in a nonhuman primate model. Cost-effective, experimental contraceptive trials can be performed in the NPCC to (1) demonstrate a contraceptive effect of chronic (6 month) administration of the agent in a breeding colony of macaques exhibiting natural menstrual cycles; and (2) document that the contraceptive effect is reversible following discontinuation for a 6 month interval. Data from these translational experiments conducted in the NPCC will increase confidence in the feasibility of considering a continual regimen of these inhibitors for clinical use as a contraceptive in women. In vivo contraceptive trials – male The Nonhuman Primate Contraceptive Core (NPCC) provides services and coordination of animal usage for U54 Contraceptive Center investigators with approved projects. Male rhesus monkeys are leased from the Oregon National Primate Research Center and trained for semen collection. Proof-of-concept studies based on semen parameters (count, motility, live-dead staining, progressive motion), testicular biopsies, hormone levels and pharmacokinetics can be performed. Contraceptive (mating) trials are coordinated and performed studies using small harem groups of cynomolgus or rhesus female. The NPCC confirms menstruation and ensures mating has occurred by taking vaginal swabs; performs ultrasounds to monitor for pregnancies; and obtains blood samples for hormone assays, pharmacokinetic studies and metabolic profiles. The Core acclimates the females to a small group (harem) housing situation (8-10 females to one male) wherein they can be separated for daily vaginal checks, dosing, blood sampling and ultrasound analyses. The NPCC is uniquely poised to drive proof-of-concept studies in nonhuman primates that can be readily translated into further efforts to test novel contraceptives in men. The final stage in the strategy to discover novel agents for male fertility regulation will be to evaluate the efficacy of these agents as reversible contraceptive agents in a nonhuman primate model. Cost-effective, experimental contraceptive trials can be performed in the NPCC to (1) demonstrate a contraceptive effect of chronic (6 month) administration of the agent to males housed in a breeding colony of female macaques exhibiting natural menstrual cycles; and (2) document that the contraceptive effect is reversible following discontinuation for a 6 month interval. Data from these translational experiments conducted in the NPCC will increase confidence in the feasibility of considering a these agents for clinical use as a contraceptive in men.

2. Contact

   Zelinski, Mary, Ph.D.

3. Used by

   Mary Zelinski Laboratory

4. Author

   Zelinski, Mary, Ph.D.