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

"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: A Single-blind, Randomized Controlled, Non-inferiority Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Participants will: Take Estetrol/Drospirenone or Ethinyl estradiol/Gestodene starting on day 7-9 of menstrual cycle then every day for 1 pack of the pills. Visit the clinic on day 1-2, day 7-9, and then every 2-7 days according to ultrasound finding (ovarian activities) until completing of pills to investigate 1. Transvaginal ultrasound 2. Cervical mucus 3. Serum hormonal profiles.

Conditions

• Ultrasound Finding: Ovulation Inhibition, Ovarian Activities
• Cervical Mucus
• Serum Hormonal Profile

Interventions

Type	Name	Description
DRUG	Estetrol 15 mg/Drospirenone 3 mg (24/4)	Completing a pack (28 pills) of Estetrol 15 mg/Drospirenone 3 mg (24/4), starting on day 7-9 of menstrual cycle
DRUG	Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7)	Completing a pack (28 pills) of Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7), starting on day 7-9 of menstrual cycle

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2024-05-02
• Last updated: 2025-05-20

Locations

1 site across 1 country: Thailand