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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:
Researchers will compare Estetrol/Drospirenone to Ethinyl estradiol/Gestodene to see if Estetrol/Drospirenone inhibit ovulation in quick-starting method.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Estetrol 15 mg/Drospirenone 3 mg (24/4) | Experimental |
| |
| Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estetrol 15 mg/Drospirenone 3 mg (24/4) | Drug | Completing a pack (28 pills) of Estetrol 15 mg/Drospirenone 3 mg (24/4), starting on day 7-9 of menstrual cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of ovulation inhibition and classify ovarian activities using transvaginal ultrasound | Visit the clinic on day 1-2, day 7-9, and then every 2-7 days according to ultrasound finding until completing a package of pills
| 34-36 days |
| Measure | Description | Time Frame |
|---|---|---|
| Level of serum hormonal profiles: Estradiol, Progesterone, LH | Visit the clinic on day 1-2, day 7-9, and then every 2-7 days according to ultrasound finding
|
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Somsook Santibenchakul, Master | Obstetric and gynecology department, Faculty of medicine, Chulalongkorn University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Chulalongkorn Memorial Hospital | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41388035 | Derived | Ittipuripat S, Phutrakool P, Uaamnuichai S, Porntawansak G, Wongwathanavikrom R, Utaipatanacheep P, Santibenchakul S. Delayed start of estetrol drospirenone versus ethinyl estradiol gestodene for ovulation inhibition in a noninferiority randomized controlled trial. Sci Rep. 2025 Dec 12;15(1):43682. doi: 10.1038/s41598-025-27467-y. |
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| Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7) | Drug | Completing a pack (28 pills) of Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7), starting on day 7-9 of menstrual cycle |
|
| Cervical mucus classification |
| Cervical mucus | Visit the clinic on day 1-2, day 7-9, and then every 2-7 days according to ultrasound finding
| 34-36 days |
| ID | Term |
|---|---|
| D004953 | Estetrol |
| C035144 | drospirenone |
| D004997 | Ethinyl Estradiol |
| C033273 | Gestodene |
| ID | Term |
|---|---|
| D004964 | Estriol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D042782 | Estrogenic Steroids, Alkylated |
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