CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 62 enrolled
Drug / intervention
LNG+EE2 +1 moredrug
Likely dose
LNG+EE2 0.15 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/NCT01480778
NCT01480778Phase 3Completed
CompareCT.gov

Pharmacodynamic Assessment to Drug Ciclo 21 (Levonorgestrel + Ethinyl Estradiol) Market by União Química Farmacêutica Nacional S/A Compared to Drug Nordette of Wieth Indústria Farmacêutica Ltda.

Azidus Brasil·interventional·Posted Nov 29, 2011·Updated Mar 3, 2016

In Brief

A Phase 3 clinical trial evaluating LNG+EE2 and Nordette for Irregular Periods. Completed, enrolled 62 participants across 1 site.

Detailed Summary

Assessment of the pharmacodynamic profile of the drug Ciclo 21 ®, marketed by União Química Farmacêutica Nacional S / A, compared to the drug Nordette ® Laboratory Wyeth Pharmaceutical Ltda. Through the modulation of hormonal response (inhibition of the pituitary) evidenced by measurement serum LH and FSH for 28 days, as well as by the absence of follicle formation demonstrated by transvaginal ultrasound examinations

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrregular Periods
CountriesBrazil
CollaboratorsUnião Química Farmacêutica Nacional S/A

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 29, 2011
Enrollment StartJul 1, 2014
Primary CompletionApr 1, 2015
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 14.6 years ago

Interventions

LNG+EE2drug

Administration of one pill contained 0.15 mg of levonosgestrel and 0.03 mg of ethynil estradiol per day over 21 days.

Nordettedrug

Administration of one pill contained 0.15 mg of levonosgestrel and 0.03 mg of ethynil estradiol per day over 21 days.