Berlin, 13353, Germany
NCT Number: NCT02545452
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
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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Anastrozole / Levonorgestrel (BAY98-7196)
DrugRelease rate of the IVR: 1050 μg/d ATZ + 40 μg/d LNG
Gyno-Daktarin
Drug400 mg miconazole nitrate per day for 3 consecutive days
Sobelin vaginal creme
Drug100 mg clindamycin 2-dihydrogen phosphat per day for 3 consecutive days
Patentex oval
Drug75 mg Nonoxynol-9 per day for 3 consecutive days
Tampon
OtherOther names: Tampons (3 changes per day) for 3 consecutive days
Primary outcomes
-
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups
Time frame: 202-226h
-
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups
Time frame: 226-298h
-
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups
Time frame: 226-384h
-
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group
Time frame: 466-490h
-
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group
Time frame: 490-562h
-
Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group
Time frame: 490-648h
-
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups
Time frame: 202-226h
-
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups
Time frame: 226-298h
-
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups
Time frame: 226-384h
-
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group
Time frame: 466-490h
-
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group
Time frame: 490-562h
-
Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group
Time frame: 490-648h
Secondary outcomes
-
Maximum observed plasma concentration before co-medication or tampons (Cmax)
Time frame: 490h
-
Time to reach maximum observed concentration before co-medication or tampons (tmax)
Time frame: 490h
-
Plasma concentration 28 days after intra-vaginal ring (IVR) insertion (Treatment group D, Day 29) (C(28d))
Time frame: 672h
-
Plasma concentration 35 days after IVR insertion (Treatment group D, Day 36)(C(35d))
Time frame: 840h
-
Average concentration in the extended wearing period (Treatment D, Days 29-36 using the same IVR)
Time frame: 672-840h
-
Terminal half-life associated with the terminal slope after removal of IVR (t1/2)
Time frame: Up to 6 days after IVR removal
-
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 14 days after IVR removal
Sponsors and collaborators
Lead sponsor
Bayer
Industry
Registry information
Official study 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
Important dates
- Study start
- 2015
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Sep 10, 2015
- Registry last updated
- Jul 24, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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