Effect of Concomitant Use of an Antimycotic, an Antibiotic, a Spermicide or Tampons on Pharmacokinetics of Anastrozole and Levonorgestrel Released From Intra-vaginal Ring

• Status: Completed
• Trial end date: 2016-07-29
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Anastrozole; Anti-Bacterial Agents; Antibiotics, Antitubercular; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Levonorgestrel; Miconazole; Nonoxynol; Spermatocidal Agents

Criteria

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.