CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 24 enrolled
Drug / intervention
Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tablets +2 moredrug
Likely dose
Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tablets 0.150 mgfrom 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/NCT01044056
NCT01044056Phase 4Completed

An Open-label, Randomized, Parallel Group Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30)

Organon and Co·interventional·Posted Jan 7, 2010·Updated Feb 4, 2022

In Brief

A Phase 4 clinical trial evaluating Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tablets, norelgestrominum and ethinylestradiol patch oral contraceptive patch, and 1 other intervention for Contraception. Completed, enrolled 24 participants.

Detailed Summary

An open-label, randomized, parallel group trial in healthy female subjects to compare the pharmacokinetics of ethinyl estradiol (EE) of NuvaRing®, a contraceptive patch (EVRA(TM)) and an oral contraceptive (Microgynon® 30).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 7, 2010
Enrollment StartMar 1, 2004
Primary CompletionJun 1, 2004
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.5 years ago

Interventions

Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tabletsdrug

LNG/EE oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.

norelgestrominum and ethinylestradiol patch oral contraceptive patchdrug

A contraceptive patch (EVRA ™), one patch for 7 days for three consecutive weeks, 3 patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.

Nuvaring ™ (etonorgestrel/ethinylestradiol)drug

NuvaRing ™ , one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.