Estriol and Trimegestone Dose-response Trial With Single Dose Application of Vaginal Rings
Status:
Completed
Trial end date:
2018-02-15
Target enrollment:
Participant gender:
Summary
This clinical trial is performed as proof of pharmacological action investigation by
demonstration of ovulation inhibition (dose-response study) under treatment with three Test
vaginal rings releasing varying doses of estriol (E3) and trimegestone (TMG).
Blood samples for determination of estradiol (E2) and progesterone (PG) levels will serve as
pharmacodynamic surrogate parameters for characterization of the treatment effect on the
endogenous hormones.
Blood samples for determination of E3 and TMG in plasma will be collected in order to
characterize pharmacokinetic parameters.
Additionally, local tolerability characterized by gynecological inspection of the vaginal
mucosa prior to and after insertion of the Investigational Medicinal Product (IMPs) is
planned to be assessed