CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 121 enrolled
Drug / intervention
NOMAC-E2 +1 moredrug
Likely dose
NOMAC-E2 2.5 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/NCT00511355
NCT00511355Phase 3Completed
CompareCT.gov

A Randomized, Open-Label, Comparative, Multi -Center Trial to Evaluate the Effects on Hemostasis, Lipids and Carbohydrate Metabolism, and on Adrenal and Thyroid Function of a Monophasic COC Containing 2.5 mg NOMAC and 1.5 mg E2 Compared to a Monophasic COC Containing 150 ug LNG and 30 ug EE

Organon and Co·interventional·Posted Aug 3, 2007·Updated Feb 9, 2022

In Brief

A Phase 3 clinical trial evaluating NOMAC-E2 and Levonorgestrel and Ethinyl Estradiol for Contraception. Completed, enrolled 121 participants.

Detailed Summary

The primary purpose of this study is to evaluate the effects of the combined oral contraceptive (COC) NOMAC-E2 on hemostasis, lipids, carbohydrate metabolism, adrenal function, and thyroid function.

Study Details

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

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 3, 2007
Enrollment StartOct 1, 2006
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.9 years ago

Interventions

NOMAC-E2drug

Nomegestrol Acetate and Estradiol (NOMAC-E2) Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.

Levonorgestrel and Ethinyl Estradioldrug

Levonorgestrel and Ethinyl Estradiol (LNG-EE) Tablets, 150 mcg LNG and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.