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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
Completing a pack (28 pills) of Estetrol 15 mg/Drospirenone 3 mg (24/4), starting on day 7-9 of menstrual cycle
Completing a pack (28 pills) of Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7), starting on day 7-9 of menstrual cycle
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
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 * Ultrasound will be perform by the researcher (Dr. Sirarat Itthipuripat) using transvaginal probe to all volunteers. * To monitor a leading ovarian follicle or follicle-like structures (FLS), that the ultrasound characteristic is the largest hypoechoic part (follicle) among both ovaries, to classify the ovarian activity by modified Hoogland's score (combined the result with hormonal profile: Estradiol, Progesterone) and assess rate of ovulation, that identify from postovulatory image defined as follows: * Image observed after abrupt disappearance of FLS or * Image observed after reduction in size of the leading follicle \> 4 mm at 2 consecutive visits or * Hemorrhagic or cystic corpus luteum * The detail in measuring the size of an FLS is the average of 3 longest sides perpendicular to each other in millimeter
Time frame: 34-36 days
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 * Blood test to measure estrogen level in picogram/milliliter, progesterone level in nanogram/milliliter and LH level in International unit per liter * Volunteers will be placed in a 5 ml clot activator tube and sent to the endocrinology laboratory medical operation center within 30 minutes after blood draw.
Time frame: 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 * Using Tuberculin syringe 1 mL to suck cervical mucus from the endocervical canal (1 cm deep from external cervical os) * Assess the results of cervical mucus collected immediately according to WHO 2010, consisting of volume (milliliter), viscosity, ferning appearance, Spinnbarkeit (centimeter), and cellularity (cell/high power field), under microscopy
Time frame: 34-36 days
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