CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,152 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/NCT00511199
NCT00511199Phase 3Completed
CompareCT.gov

A Randomized, Open-Label, Comparative, Multi -Center Trial to Evaluate Contraceptive Efficacy, Cycle Control, Safety and Acceptability of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2), Compared to a Monophasic COC Containing 3 mg Drospirenone (DRSP) and 30 µg Ethinyl Estradiol (EE)

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

In Brief

A Phase 3 clinical trial evaluating NOMAC-E2 and DRSP-EE for Contraception. Completed, enrolled 2,152 participants.

Detailed Summary

The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years.

Study Details

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

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 3, 2007
Enrollment StartMay 1, 2006
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 18.9 years ago

Interventions

NOMAC-E2drug

Nomegestrol Acetate and Estradiol 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 13 consecutive 28-day menstrual cycles (1 year).

DRSP-EEdrug

Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year).