Endometriosis
Conditions
Brief summary
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
Interventions
DRUGAnastrozole / Levonorgestrel (BAY98-7196)
Release rate of the IVR: 1050 μg/d ATZ + 40 μg/d LNG
DRUGGyno-Daktarin
400 mg miconazole nitrate per day for 3 consecutive days
DRUGSobelin vaginal creme
100 mg clindamycin 2-dihydrogen phosphat per day for 3 consecutive days
DRUGPatentex oval
75 mg Nonoxynol-9 per day for 3 consecutive days
OTHERTampon
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy pre-menopausal female subject. * Age: 18 - 50 years (inclusive) at the first screening visit. For the subject \> 45 years follicle stimulating hormone (FSH) will be investigated at the second screening visit to confirm the pre-menopausal status (FSH \< 40 IU/L in serum). * Body mass index (BMI ) above or equal 18, and below or equal 30 kg / m² at the first screening visit. * Adequate venous access. * Ability to understand and follow study-related instructions * Agreement to use adequate non-hormonal contraception. * Confirmation of the subject's health insurance coverage prior to the first screening examination/visit.
Exclusion criteria
* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal. * Thrombophlebitis, venous / arterial thromboembolic diseases (particularly deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction). * Presence or history of prodromata of thrombosis (e.g. transient ischemic attack, angina pectoris). * Known hypersensitivity to the study medications (active substances or excipients of the preparations). * Regular intake of medication other than hormonal contraceptives. * Use of systemic or topical medication or substances which oppose the study objectives or which might influence them within 4 weeks before first administration of the study medication, * Smoking of more than 10 cigarettes daily; if the subject is a smoker: subject is older than 35 years * Suspicion of or known current drug, medicine or alcohol abuse (including anabolics, high-dose vitamins). * Abnormal cervical smear * Previous ectopic pregnancy.
Design outcomes
Primary
| Measure | 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 Tampon group | 466-490h |
| 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 Tampon group | 466-490h |
Secondary
| Measure | Time frame |
|---|---|
| Average concentration in the extended wearing period (Treatment D, Days 29-36 using the same IVR) | 672-840h |
| Maximum observed plasma concentration before co-medication or tampons (Cmax) | 490h |
| Number of participants with adverse events as a measure of safety and tolerability | Up to 14 days after IVR removal |
| Terminal half-life associated with the terminal slope after removal of IVR (t1/2) | Up to 6 days after IVR removal |
| Time to reach maximum observed concentration before co-medication or tampons (tmax) | 490h |
| 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 |
Countries
Germany
Outcome results
None listed