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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

NCT02545452 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2017-07-24

No results posted yet for this study

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

Conditions

  • Endometriosis

Interventions

DRUG

Anastrozole / Levonorgestrel (BAY98-7196)

Release rate of the IVR: 1050 μg/d ATZ + 40 μg/d LNG

DRUG

Gyno-Daktarin

400 mg miconazole nitrate per day for 3 consecutive days

DRUG

Sobelin vaginal creme

100 mg clindamycin 2-dihydrogen phosphat per day for 3 consecutive days

DRUG

Patentex oval

75 mg Nonoxynol-9 per day for 3 consecutive days

OTHER

Tampon

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-15
Primary Completion
2016-03-14
Completion
2016-07-29

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02545452 on ClinicalTrials.gov