Clinical trial considerations on male contraception and collection of pregnancy information from female partners

Table 1 Assumptions for estimation of female partner AUC associated with vaginal dose

	Small molecules	Monoclonal antibodies
Seminal fluid concentration	C_max	1% of C_max
Seminal fluid volume	6 mL	6 mL
Vaginal absorption	100%	10%
Placental transfer	100%	10% (first trimester)
PK linearity	Yes	Yes
First pass effect	No	N/A
High protein binding	Correction for difference in fraction unbound between humans and animals tested	N/A
PK variability	Yes	Yes
Extrapolate from human PK if available; otherwise use DMPK model	Yes	Yes

C_max, maximum concentration; PK, pharmacokinetic; DMPK, drug metabolism and pharmacokinetics.

ISSN: 1479-5876