Trial Condition(s):

Endometriosis

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 Identifier:

16997

ClinicalTrials.gov Identifier:

NCT02545452

EudraCT Number:

2014-005167-32

Study Completed

Trial Purpose

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

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 Summary

Enrollment Goal
52
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Anastrozole / Levonorgestrel (BAY98-7196)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Berlin, Germany, 13353

Status
Completed
 

Trial Design