drugset / Trial / NCT02957630

"E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"

NCT02957630

Phase 1/2 Completed 101 enrolled Estetra
RandomizedParallel-groupOpen-labelPrevention

Summary

The proposed study will provide an assessment of the effect of this combination on endocrine function, metabolic control and hemostasis during 6 treatment cycles. This will be compared to the effects of two reference COCs.

Timeline

Start
2016-09
Primary completion
2017-10-09
Completion
2017-10-09

Drugs

EvaluationDrugModalityDoseRoute
Subject ESTETROL ANHYDROUS Other / unclassified 15 mg Oral
Comparator Levonorgestrel Small molecule 150 ug Oral
Subject drospirenone Unknown 3 mg Oral
Comparator ethinyl estradiol Small molecule 20 ug Oral
Comparator ethinyl estradiol Small molecule 30 ug Oral

Indications

No indication recorded.