Pregnancy Clinical Trial
Official title:
Dose-response Study With Three Vaginal Rings With Different Doses of Estriol and Trimegestone: Effect on Progesterone and Estradiol Levels in Healthy Females With Childbearing Potential
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
The IMPs, releasing either 0.400 mg E3 and 0.06 mg TMG, or 0.300 mg E3 and 0.12 mg TMG, or
0.200 mg E3 and 0.18 mg TMG per 24 h, will be applied intravaginally and remain in the vagina
for the subsequent 21 days (single dose, 1 treatment cycle). A total of 36 female subjects,
12 per treatment group, are intended to be randomized.
Blood samples for determination of E2 and PG levels will be collected during treatment and
until 20 days after removal of the ring. Blood samples for determination of E3 and TMG in
plasma will be collected over the treatment period and until 48 h after removal of the ring.
Bleeding intensity will also be documented during treatment and until 20 days after removal
of the vaginal ring in a diary to characterize the effects of the different treatments.
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