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Effects of Cladribine Tablets on the PK of Microgynon®

NCT03745144 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-03-15

Study results available
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Summary

The purpose of this study was to investigate the potential effects of cladribine on the pharmacokinetics (PK) of monophasic oral contraceptive microgynon® by assessment of its constituents, ethinyl estradiol (EE) and levonorgestrel (LNG).

Conditions

  • Relapsing Multiple Sclerosis (RMS)

Interventions

DRUG

Cladribine

Participants received cladribine once-daily for 5 consecutive days in treatment period 1 and 2.

DRUG

Placebo

Participants received placebo matched to cladribine once-daily for 5 consecutive days in treatment period 1 and 2.

DRUG

Microgynon®

Participants received Microgynon® tablet once daily for 21 days in treatment period 1 and 2. Participants received Microgynon® for 21 days, starting on the first day of the menstrual cycle in Run-in period.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-17
Primary Completion
2022-09-02
Completion
2022-09-16

Countries

  • Germany
  • Poland

Study Locations

More Related Trials

Entities

Drugs

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 NCT03745144 on ClinicalTrials.gov