Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396221
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-25
Brief Title:
Quick-starting of a New Combined Hormonal Contraceptive Pills 15 mg Estetrol3 mg Drospirenone VS 20 mcg Ethinylestradiol75 mcg Gestodene Focusing on Ovulation Inhibition
Sponsor:
Chulalongkorn University
Organization:
Chulalongkorn University
Study Overview
Official Title:
Quick-starting of a New Combined Hormonal Contraceptive Pills 15 mg Estetrol3 mg Drospirenone VS 20 mcg Ethinylestradiol75 mcg Gestodene Focusing on Ovulation Inhibition A Single-blind Randomized Controlled Non-inferiority Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if EstetrolDrospirenone inhibit ovulation in quick-starting method It will also learn about the safety of EstetrolDrospirenone The main questions it aims to answer are
1 Does EstetrolDrospirenone inhibit ovulation inferior to Ethinyl estradiolGestodene when starting on Day 7-9 of menstrual cycle
2 What are the impacts of EstetrolDrospirenone on ovarian activities when starting on Day 7-9 of menstrual cycle
3 How does the cervical mucus change when starting EstetrolDrospirenone on Day 7-9 of menstrual cycle
4 What are the adverse effects when starting EstetrolDrospirenone on Day 7-9 of menstrual cycle
Researchers will compare EstetrolDrospirenone to Ethinyl estradiolGestodene to see if EstetrolDrospirenone inhibit ovulation in quick-starting method
1 Does EstetrolDrospirenone inhibit ovulation inferior to Ethinyl estradiolGestodene when starting on Day 7-9 of menstrual cycle
2 What are the impacts of EstetrolDrospirenone on ovarian activities when starting on Day 7-9 of menstrual cycle
3 How does the cervical mucus change when starting EstetrolDrospirenone on Day 7-9 of menstrual cycle
4 What are the adverse effects when starting EstetrolDrospirenone on Day 7-9 of menstrual cycle
Researchers will compare EstetrolDrospirenone to Ethinyl estradiolGestodene to see if EstetrolDrospirenone inhibit ovulation in quick-starting method
Detailed Description:
Participants will
Take EstetrolDrospirenone or Ethinyl estradiolGestodene 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
Take EstetrolDrospirenone or Ethinyl estradiolGestodene 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None