To investigate the pharmacokinetic effect of a vaginally administered antimycotic (miconazole), antibiotic (clindamycin), spermicide (nonoxynol-9) or the concomitant use of tampons during the use of an intravaginal ring releasing anastrozole and levonorgestrel
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
52
Release rate of the IVR: 1050 μg/d ATZ + 40 μg/d LNG
400 mg miconazole nitrate per day for 3 consecutive days
100 mg clindamycin 2-dihydrogen phosphat per day for 3 consecutive days
Unnamed facility
Berlin, Germany
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups
Time frame: 202-226h
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups
Time frame: 226-298h
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups
Time frame: 226-384h
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group
Time frame: 466-490h
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group
Time frame: 490-562h
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group
Time frame: 490-648h
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups
Time frame: 202-226h
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups
Time frame: 226-298h
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups
Time frame: 226-384h
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group
Time frame: 466-490h
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group
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75 mg Nonoxynol-9 per day for 3 consecutive days
Time frame: 490-562h
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group
Time frame: 490-648h
Maximum observed plasma concentration before co-medication or tampons (Cmax)
Time frame: 490h
Time to reach maximum observed concentration before co-medication or tampons (tmax)
Time frame: 490h
Plasma concentration 28 days after intra-vaginal ring (IVR) insertion (Treatment group D, Day 29) (C(28d))
Time frame: 672h
Plasma concentration 35 days after IVR insertion (Treatment group D, Day 36)(C(35d))
Time frame: 840h
Average concentration in the extended wearing period (Treatment D, Days 29-36 using the same IVR)
Time frame: 672-840h
Terminal half-life associated with the terminal slope after removal of IVR (t1/2)
Time frame: Up to 6 days after IVR removal
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 14 days after IVR removal