"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
NCT ID: NCT06396208
Last Updated: 2025-05-14
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
40 participants
INTERVENTIONAL
2024-05-01
2024-10-31
Brief Summary
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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.
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Detailed Description
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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
* Transvaginal ultrasound
* Cervical mucus
* Serum hormonal profiles.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Quadriphasic Estradiol valerate 1 - 3 mg/ Dienogest 2 - 3 mg (26/2)
Completing a pack (28 pills) of Quadriphasic Estradiol valerate 1 - 3 mg/ Dienogest 2 - 3 mg (26/2), starting on day 7-9 of menstrual cycle
Quadriphasic Estradiol valerate 1 - 3 mg/ Dienogest 2 - 3 mg (26/2)
Completing a pack (28 pills) of Quadriphasic Estradiol valerate 1 - 3 mg/ Dienogest 2 - 3 mg (26/2), 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
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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Quadriphasic Estradiol valerate 1 - 3 mg/ Dienogest 2 - 3 mg (26/2)
Completing a pack (28 pills) of Quadriphasic Estradiol valerate 1 - 3 mg/ Dienogest 2 - 3 mg (26/2), 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
* 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
* 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
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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IRB0838/66
Identifier Type: -
Identifier Source: org_study_id
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