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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005167-32 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY98-7196 | Experimental | Investigate the pharmacokinetics effect of a vaginally administered antimycotic (miconazole) during the use of an intra-vaginal ring (IVR) releasing anastrozole (ATZ) and levonorgestrel (LNG) |
|
| Administered Antibiotic | Experimental | Investigate the pharmacokinetics effect of a vaginally administered antibiotic (clindamycin) during the use of an IVR releasing ATZ and LNG |
|
| Administered Spermicide | Experimental | Investigate the pharmacokinetics effect of a vaginally administered spermicide (nonoxynol-9) during the use of an IVR releasing ATZ and LNG |
|
| Tampons | Experimental | Investigate the pharmacokinetics effect of the concomitant use of tampons during the use of an IVR releasing ATZ and LNG; investigate the pharmacokinetics over an extended IVR wearing period of 35 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anastrozole / Levonorgestrel (BAY98-7196) | Drug | Release rate of the IVR: 1050 μg/d ATZ + 40 μg/d LNG |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups | 202-226h | |
| Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups | 226-298h | |
| Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups | 226-384h | |
| Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group | 466-490h | |
| Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group | 490-562h | |
| Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group | 490-648h | |
| Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups | 202-226h | |
| Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups | 226-298h | |
| Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups | 226-384h | |
| Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration before co-medication or tampons (Cmax) | 490h | |
| Time to reach maximum observed concentration before co-medication or tampons (tmax) | 490h | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin | 13353 | Germany |
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| Gyno-Daktarin | Drug | 400 mg miconazole nitrate per day for 3 consecutive days |
|
| Sobelin vaginal creme | Drug | 100 mg clindamycin 2-dihydrogen phosphat per day for 3 consecutive days |
|
| Patentex oval | Drug | 75 mg Nonoxynol-9 per day for 3 consecutive days |
|
| Tampon | Other |
|
|
| 466-490h |
| Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group | 490-562h |
| Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group | 490-648h |
| Plasma concentration 28 days after intra-vaginal ring (IVR) insertion (Treatment group D, Day 29) (C(28d)) |
| 672h |
| Plasma concentration 35 days after IVR insertion (Treatment group D, Day 36)(C(35d)) | 840h |
| Average concentration in the extended wearing period (Treatment D, Days 29-36 using the same IVR) | 672-840h |
| Terminal half-life associated with the terminal slope after removal of IVR (t1/2) | Up to 6 days after IVR removal |
| Number of participants with adverse events as a measure of safety and tolerability | Up to 14 days after IVR removal |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| D016912 | Levonorgestrel |
| D003022 | Clotrimazole |
| D017137 | Nonoxynol |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D007093 | Imidazoles |
| D011092 | Polyethylene Glycols |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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