drugset / Trial / NCT06396221

"Quick-starting" of a New Combined Hormonal Contraceptive Pills, 15 mg Estetrol/3 mg Drospirenone VS 20 mcg Ethinylestradiol/75 mcg Gestodene Focusing on Ovulation Inhibition

NCT06396221

Completed 36 enrolled Chulalongkorn University
RandomizedParallel-groupSingle-blindTreatment

Summary

The goal of this clinical trial is to learn if Estetrol/Drospirenone inhibit ovulation in quick-starting method. It will also learn about the safety of Estetrol/Drospirenone. The main questions it aims to answer are: 1. Does Estetrol/Drospirenone inhibit ovulation inferior to Ethinyl estradiol/Gestodene when starting on Day 7-9 of menstrual cycle? 2. What are the impacts of Estetrol/Drospirenone on ovarian activities when starting on Day 7-9 of menstrual cycle? 3. How does the cervical mucus change when starting Estetrol/Drospirenone on Day 7-9 of menstrual cycle? 4. What are the adverse effects when starting Estetrol/Drospirenone on Day 7-9 of menstrual cycle? Researchers will compare Estetrol/Drospirenone to Ethinyl estradiol/Gestodene to see if Estetrol/Drospirenone inhibit ovulation in quick-starting method.

Timeline

Start
2024-05-01
Primary completion
2024-09-30
Completion
2024-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject ESTETROL ANHYDROUS Other / unclassified 15 mg Oral
Comparator Gestodene Small molecule 75 ug Oral
Subject drospirenone Unknown 3 mg Oral
Comparator ethinyl estradiol Small molecule 20 ug Oral

Indications