From female adolescents, where contraception should be as efficacious and safe as possible, to postmenopausal women in need of a hormone replacement therapy – for nearly the whole life sexual hormones are of therapeutic relevance also in the healthy.
Although half of the human population is affected, females in pharmaceutical research are still considered as a special population. Not only in regard to pharmacokinetics but also for pharmacodynamics, safety and efficacy, gender-related differences are always of relevance and require specific knowledge.
The first study ever run at SocraTec R&D was a pharmacodynamic trial with postmenopausal women investigating pharmacokinetics and effect on endometrial thickness and maturation index. Since then we have continuously improved our knowledge of and experience with sexual hormones
To extend gynaecological and especially endometriosis research capabilities, SocraTec R&D has joined capabilities with dinox to successfully realize clinical trials in the field of endometriosis in early and late stage development.
Together, we implement our customers‘ overall development program, from first-in-human, proof-of-concept, cycle and ovulation impact studies to pivotal efficacy trials.