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

Bayer

Status and phase: Completed; Phase 1

Conditions: Endometriosis

Treatments: Other: Tampon; Drug: Sobelin vaginal creme; Drug: Patentex oval; Drug: Anastrozole / Levonorgestrel (BAY98-7196); Drug: Gyno-Daktarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02545452

2014-005167-32 (EudraCT Number)

16997

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 4 patient groups

BAY98-7196

Experimental group

Description:

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)

Treatment:

Drug: Gyno-Daktarin

Drug: Anastrozole / Levonorgestrel (BAY98-7196)

Administered Antibiotic

Experimental group

Description:

Investigate the pharmacokinetics effect of a vaginally administered antibiotic (clindamycin) during the use of an IVR releasing ATZ and LNG

Treatment:

Drug: Sobelin vaginal creme

Drug: Anastrozole / Levonorgestrel (BAY98-7196)

Administered Spermicide

Experimental group

Description:

Investigate the pharmacokinetics effect of a vaginally administered spermicide (nonoxynol-9) during the use of an IVR releasing ATZ and LNG

Treatment:

Drug: Patentex oval

Drug: Anastrozole / Levonorgestrel (BAY98-7196)

Tampons

Experimental group

Description:

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

Treatment:

Drug: Anastrozole / Levonorgestrel (BAY98-7196)

Other: Tampon