Trial Evaluating Folic Acid Supplementation by Concomitant Administration of Ethinyl Estradiol + Levonorgestrel

Phase 3 Completed 36 enrolled Galeno Desenvolvimento de Pesquisas Clínicas Biolab Sanus Farmaceutica · collab

Non-randomizedSequentialQuadruple-blindTreatment

Summary

This trial evaluated folic acid supplementation after oral administration of the ethinyl estradiol + levonorgestrel + folic acid (0.02 mg + 0.10 mg + 0.4 mg) coated tablet (Level-Fol® Biolab Sanus Farmacêutica, São Paulo, Brazil) in healthy female volunteers, based on statistical comparisons of folate levels in erythrocytes. Its safety and tolerability was also evaluated.

Timeline

Start: 2013-02-26
Primary completion: 2013-07-04
Completion: 2013-09-17

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levonorgestrel	Small molecule	0.1 mg	Oral
Subject	ethinyl estradiol	Small molecule	0.02 mg	Oral
Subject	folic acid	Other / unclassified	0.4 mg	Oral

Indications

No indication recorded.