"Quick-starting" of a New Combined Hormonal Contraceptive Pills, 15 mg Estetrol/3 mg Drospirenone VS 20 mcg Ethinylestradiol/75 mcg Gestodene Focusing on Ovulation Inhibition
NCT ID: NCT06396221
Last Updated: 2025-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2024-05-01
2024-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
2. Estetrol 15 mg/Drospirenone 3 mg (24/4) as intervention group
TREATMENT
SINGLE
Study Groups
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Estetrol 15 mg/Drospirenone 3 mg (24/4)
Estetrol 15 mg/Drospirenone 3 mg (24/4)
Completing a pack (28 pills) of Estetrol 15 mg/Drospirenone 3 mg (24/4), starting on day 7-9 of menstrual cycle
Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7)
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
Interventions
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Estetrol 15 mg/Drospirenone 3 mg (24/4)
Completing a pack (28 pills) of Estetrol 15 mg/Drospirenone 3 mg (24/4), starting on day 7-9 of menstrual cycle
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
Eligibility Criteria
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Inclusion Criteria
2. Body mass index 18-30 kg/m²
3. Menstrual interval within 24 - 38 days
4. Absence of history of estrogen or progestin allergy and Absence of these compatibles with U.S. medical eligibility criteria category 3 - 4
5. Consent to use condom as contraception or have been sterilized
Exclusion Criteria
2. Current pregnant or within 3 months of breastfeeding
3. Having ovarian cyst(s) or tumor(s)
4. Being a cervical cancer patient or having precancerous cervical lesion
18 Years
45 Years
FEMALE
Yes
Sponsors
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Chulalongkorn University
OTHER
Responsible Party
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Principal Investigators
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Somsook Santibenchakul, Master
Role: STUDY_DIRECTOR
Obstetric and gynecology department, Faculty of medicine, Chulalongkorn University
Locations
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King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Countries
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Other Identifiers
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IRB0839/66
Identifier Type: -
Identifier Source: org_study_id
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