A Parallel Group, Randomized, Open-label Study to Investigate the Effect of the Intravaginally Administered Antimycotic Miconazole, Antibiotic Clindamycin, Spermicide Nonoxynol-9, or Co-usage of Tampons on 3 Consecutive Days on the Pharmacokinetics of Anastrozole and Levonorgestrel Released From an Intra-vaginal Ring in Healthy Young Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 52
- 主要终点
- Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
BAY98-7196
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)
干预措施: Anastrozole / Levonorgestrel (BAY98-7196) (Drug)
BAY98-7196
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)
干预措施: Gyno-Daktarin (Drug)
Administered Antibiotic
Investigate the pharmacokinetics effect of a vaginally administered antibiotic (clindamycin) during the use of an IVR releasing ATZ and LNG
干预措施: Anastrozole / Levonorgestrel (BAY98-7196) (Drug)
Administered Antibiotic
Investigate the pharmacokinetics effect of a vaginally administered antibiotic (clindamycin) during the use of an IVR releasing ATZ and LNG
干预措施: Sobelin vaginal creme (Drug)
Administered Spermicide
Investigate the pharmacokinetics effect of a vaginally administered spermicide (nonoxynol-9) during the use of an IVR releasing ATZ and LNG
干预措施: Anastrozole / Levonorgestrel (BAY98-7196) (Drug)
Administered Spermicide
Investigate the pharmacokinetics effect of a vaginally administered spermicide (nonoxynol-9) during the use of an IVR releasing ATZ and LNG
干预措施: Patentex oval (Drug)
Tampons
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
干预措施: Anastrozole / Levonorgestrel (BAY98-7196) (Drug)
Tampons
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
干预措施: Tampon (Other)
结局指标
主要结局
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups
时间窗: 226-384h
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group
时间窗: 490-648h
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups
时间窗: 226-384h
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group
时间窗: 490-648h
次要结局
- Maximum observed plasma concentration before co-medication or tampons (Cmax)(490h)
- 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)
- 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)