Gynaecological trials

Aspects that matter

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.

Years of experience

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

  • Pharmacokinetics of sexual hormones including relevance of SHBG
  • Pharmacodynamic effects of contraceptives including ovulation inhibition
  • Pharmacodynamics of HRT in postmenopausal women (systemically and locally applied)
  • Efficacy and safety of hormonal contraception and hormone replacement

Endometriosis capabilities extended

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.

For more detailed information please feel free to download our flyer: Gynaecology SRD & dinox Flyer

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