Back to resultsEffect of Concomitant Use of an Antimycotic, an Antibiotic, a Spermicide or Tampons on Pharmacokinetics of Anastrozole and Levonorgestrel Released From Intra-vaginal Ring
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Anastrozole / Levonorgestrel (BAY98-7196)
Gyno-Daktarin
Sobelin vaginal creme
Patentex oval
Tampon
Sponsored by
About this trial
This is an interventional diagnostic trial for Endometriosis
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
BAY98-7196
Administered Antibiotic
Administered Spermicide
Tampons
Arm 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)
Investigate the pharmacokinetics effect of a vaginally administered antibiotic (clindamycin) during the use of an IVR releasing ATZ and LNG
Investigate the pharmacokinetics effect of a vaginally administered spermicide (nonoxynol-9) during the use of an IVR releasing ATZ and LNG
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
Outcomes
Primary Outcome Measures
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group
Secondary Outcome Measures
Maximum observed plasma concentration before co-medication or tampons (Cmax)
Time to reach maximum observed concentration before co-medication or tampons (tmax)
Plasma concentration 28 days after intra-vaginal ring (IVR) insertion (Treatment group D, Day 29) (C(28d))
Plasma concentration 35 days after IVR insertion (Treatment group D, Day 36)(C(35d))
Average concentration in the extended wearing period (Treatment D, Days 29-36 using the same IVR)
Terminal half-life associated with the terminal slope after removal of IVR (t1/2)
Number of participants with adverse events as a measure of safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02545452
Brief Title
Effect of Concomitant Use of an Antimycotic, an Antibiotic, a Spermicide or Tampons on Pharmacokinetics of Anastrozole and Levonorgestrel Released From Intra-vaginal Ring
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 15, 2015 (Actual)
Primary Completion Date
March 14, 2016 (Actual)
Study Completion Date
July 29, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BAY98-7196
Arm Type
Experimental
Arm 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)
Arm Title
Administered Antibiotic
Arm Type
Experimental
Arm Description
Investigate the pharmacokinetics effect of a vaginally administered antibiotic (clindamycin) during the use of an IVR releasing ATZ and LNG
Arm Title
Administered Spermicide
Arm Type
Experimental
Arm Description
Investigate the pharmacokinetics effect of a vaginally administered spermicide (nonoxynol-9) during the use of an IVR releasing ATZ and LNG
Arm Title
Tampons
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Anastrozole / Levonorgestrel (BAY98-7196)
Intervention Description
Release rate of the IVR: 1050 μg/d ATZ + 40 μg/d LNG
Intervention Type
Drug
Intervention Name(s)
Gyno-Daktarin
Intervention Description
400 mg miconazole nitrate per day for 3 consecutive days
Intervention Type
Drug
Intervention Name(s)
Sobelin vaginal creme
Intervention Description
100 mg clindamycin 2-dihydrogen phosphat per day for 3 consecutive days
Intervention Type
Drug
Intervention Name(s)
Patentex oval
Intervention Description
75 mg Nonoxynol-9 per day for 3 consecutive days
Intervention Type
Other
Intervention Name(s)
Tampon
Other Intervention Name(s)
Tampons (3 changes per day) for 3 consecutive days
Primary Outcome Measure Information:
Title
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups
Time Frame
202-226h
Title
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups
Time Frame
226-298h
Title
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups
Time Frame
226-384h
Title
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group
Time Frame
466-490h
Title
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group
Time Frame
490-562h
Title
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group
Time Frame
490-648h
Title
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups
Time Frame
202-226h
Title
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups
Time Frame
226-298h
Title
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups
Time Frame
226-384h
Title
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group
Time Frame
466-490h
Title
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group
Time Frame
490-562h
Title
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group
Time Frame
490-648h
Secondary Outcome Measure Information:
Title
Maximum observed plasma concentration before co-medication or tampons (Cmax)
Time Frame
490h
Title
Time to reach maximum observed concentration before co-medication or tampons (tmax)
Time Frame
490h
Title
Plasma concentration 28 days after intra-vaginal ring (IVR) insertion (Treatment group D, Day 29) (C(28d))
Time Frame
672h
Title
Plasma concentration 35 days after IVR insertion (Treatment group D, Day 36)(C(35d))
Time Frame
840h
Title
Average concentration in the extended wearing period (Treatment D, Days 29-36 using the same IVR)
Time Frame
672-840h
Title
Terminal half-life associated with the terminal slope after removal of IVR (t1/2)
Time Frame
Up to 6 days after IVR removal
Title
Number of participants with adverse events as a measure of safety and tolerability
Time Frame
Up to 14 days after IVR removal
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Berlin
ZIP/Postal Code
13353
Country
Germany
12. IPD Sharing Statement
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Effect of Concomitant Use of an Antimycotic, an Antibiotic, a Spermicide or Tampons on Pharmacokinetics of Anastrozole and Levonorgestrel Released From Intra-vaginal Ring
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