Clinical trial 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
Official title: "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: A Single-blind, Randomized Controlled, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound Finding: Ovulation Inhibition, Ovarian Activities
Cervical Mucus
Serum Hormonal Profile
Keywords: Quick starting contraception
Quadriphasic combined hormonal contraceptive pill(s)
Estradiol valerate/Dienogest
Ovulation inhibition
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7) as control group Quadriphasic Estradiol valerate 1 - 3 mg/ Dienogest 2 - 3 mg (26/2) as intervention group
Primary purpose: TREATMENT

Brief 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.

Detailed description: Take Estradiol valerate/Dienogest 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

* Transvaginal ultrasound
* Cervical mucus
* Serum hormonal profiles.

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

Primary outcomes:
measure: Rate of ovulation inhibition and classify ovarian activities using transvaginal ultrasound
timeFrame: 34-36 days
Secondary outcomes:
measure: Level of serum hormonal profiles: Estradiol, Progesterone, LH
timeFrame: 34-36 days
measure: Cervical mucus classification
timeFrame: 34-36 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
Study officials:
affiliation: Obstetric and gynecology department, Faculty of medicine, Chulalongkorn University
name: Somsook Santibenchakul, Master
role: STUDY_DIRECTOR
References: