NCT06396208

"Quick-starting" of a Quadriphasic Contraceptive Pills, 1 - 3 mg Estradiol Valerate/ 2 - 3 mg Dienogest VS 20 mcg Ethinylestradiol/75 mcg Gestodene Focusing on Ovulation Inhibition

"Quick-starting" of a Quadriphasic Contraceptive Pills, 1 - 3 mg Estradiol Valerate/ 2 - 3 mg Dienogest 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: 40 (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: Does Estradiol valerate/Dienogest inhibit ovulation inferior to Ethinyl estradiol/Gestodene when starting on Day 7-9 of menstrual cycle? What are the impacts of Estradiol valerate/Dienogest on ovarian activities when starting on Day 7-9 of menstrual cycle? How does the cervical mucus change when starting Estradiol valerate/Dienogest on Day 7-9 of menstrual cycle? What are the adverse effects when starting Estradiol valerate/Dienogest on Day 7-9 of menstrual cycle? Researchers will compare Estradiol valerate/Dienogest to Ethinyl estradiol/Gestodene to see if Estradiol valerate/Dienogest inhibit ovulation in quick-starting method.

Detailed description

Take Estradiol valerate/Dienogest 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 * Transvaginal ultrasound * Cervical mucus * Serum hormonal profiles.

Conditions

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

Interventions

Type	Name	Description
DRUG	Quadriphasic Estradiol valerate 1 - 3 mg/ Dienogest 2 - 3 mg (26/2)	Completing a pack (28 pills) of Quadriphasic Estradiol valerate 1 - 3 mg/ Dienogest 2 - 3 mg (26/2), 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: 2024-10-31
• Completion: 2024-10-31
• First posted: 2024-05-02
• Last updated: 2025-05-14

Locations

1 site across 1 country: Thailand