CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 28 enrolled
Drug / intervention
Cladribine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03745144
NCT03745144Phase 1Completed
CompareCT.gov

A Randomized, Double-blind, 2-Period, 2-Sequence Crossover Phase I Study With a 1 Month run-in Period to Examine the Effect of Cladribine Tablets on the PK of a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel (Microgynon®) in Pre-Menopausal Women With RMS

Merck KGaA, Darmstadt, Germany·interventional·Posted Nov 19, 2018·Updated Mar 15, 2024

In Brief

A Phase 1 clinical trial evaluating Cladribine, Placebo, and 1 other intervention for Relapsing Multiple Sclerosis (RMS). Completed, enrolled 28 participants across 7 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Multiple Sclerosis (RMS)
CountriesGermany, Poland
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedNov 19, 2018
Enrollment StartJan 17, 2019
Primary CompletionSep 2, 2022
Study CompletionSep 16, 2022
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 7.6 years ago

Interventions

Cladribinedrug

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

Placebodrug

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

Microgynon®drug

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.