Effect of concomitant use of an antimycotic, an antibiotic, a spermicide or tampons on pharmacokinetics of anastrozole and levonorgestrel released from intra-vaginal ring
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
- 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.
- 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.
Berlin, Germany, 13353
E-mail: [email protected]
Phone: Not Available
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