At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 48 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.
A Randomized, Open-Label, Comparative Trial to Evaluate the Effects on Ovarian Function 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 ug Ethinyl Estradiol (EE)
In Brief
A Phase 3 clinical trial evaluating NOMAC-E2 and DRSP-EE for Contraception. Completed, enrolled 48 participants.
Detailed Summary
The primary purpose of this study is to evaluate the effects of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) on ovarian function.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2006
First PostedAug 2007
Primary CompletionJan 2008
TodayJul 2026
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 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 menstrual cycles.
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 6 consecutive 28-day menstrual cycles.