Effect of Concomitant Use of an Antimycotic, an Antibiotic, a Spermicide or Tampons on Pharmacokinetics of Anastrozole and Levonorgestrel Released From Intra-vaginal Ring
NCT ID: NCT02545452
Last Updated: 2017-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2015-09-15
2016-07-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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)
Anastrozole / Levonorgestrel (BAY98-7196)
Release rate of the IVR: 1050 μg/d ATZ + 40 μg/d LNG
Gyno-Daktarin
400 mg miconazole nitrate per day for 3 consecutive days
Administered Antibiotic
Investigate the pharmacokinetics effect of a vaginally administered antibiotic (clindamycin) during the use of an IVR releasing ATZ and LNG
Anastrozole / Levonorgestrel (BAY98-7196)
Release rate of the IVR: 1050 μg/d ATZ + 40 μg/d LNG
Sobelin vaginal creme
100 mg clindamycin 2-dihydrogen phosphat per day for 3 consecutive days
Administered Spermicide
Investigate the pharmacokinetics effect of a vaginally administered spermicide (nonoxynol-9) during the use of an IVR releasing ATZ and LNG
Anastrozole / Levonorgestrel (BAY98-7196)
Release rate of the IVR: 1050 μg/d ATZ + 40 μg/d LNG
Patentex oval
75 mg Nonoxynol-9 per day for 3 consecutive days
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
Anastrozole / Levonorgestrel (BAY98-7196)
Release rate of the IVR: 1050 μg/d ATZ + 40 μg/d LNG
Tampon
Interventions
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Anastrozole / Levonorgestrel (BAY98-7196)
Release rate of the IVR: 1050 μg/d ATZ + 40 μg/d LNG
Gyno-Daktarin
400 mg miconazole nitrate per day for 3 consecutive days
Sobelin vaginal creme
100 mg clindamycin 2-dihydrogen phosphat per day for 3 consecutive days
Patentex oval
75 mg Nonoxynol-9 per day for 3 consecutive days
Tampon
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
FEMALE
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Berlin, , Germany
Countries
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Other Identifiers
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2014-005167-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16997
Identifier Type: -
Identifier Source: org_study_id
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