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Completed
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
Conditions: Ultrasound Finding: Ovulation Inhibition, Ovarian Activities, Cervical Mucus, Serum Hormonal Profile
Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 40
Sponsor: Chulalongkorn University
Location: King Chulalongkorn Memorial Hospital Bangkok
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.
Eligibility Criteria
Inclusion Criteria:
* Women aged 18 - 45 years old
* Body mass index 18-30 kg/m²
* Menstrual interval within 24 - 38 days
* Absence of history of estrogen or progestin allergy and Absence of these compatibles with U.S. medical eligibility criteria category 3 - 4
* Consent to use condom as contraception or have been sterilized
Exclusion Criteria:
* History of estrogen, progestin or testosterone use within 3 months
* Current pregnant or within 3 months of breastfeeding
* Having ovarian cyst(s) or tumor(s)
* Being a cervical cancer patient or having precancerous cervical lesion
Source: ClinicalTrials.gov (NCT06396208). StuddyBuddy aggregates publicly available trial information.