"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

Not Applicable

Completed

• Conditions: Ultrasound Finding: Ovulation Inhibition, Ovarian Activities; Cervical Mucus; Serum Hormonal Profile
• Interventions: Drug: Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7); Drug: Estetrol 15 mg/Drospirenone 3 mg (24/4)

• Registration Number: NCT06396221
• Lead Sponsor: Chulalongkorn University

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:

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.

Detailed Description

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 Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-30
• Study Start: 2024-05-01
• Study First Posted: 2024-05-02
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

1. Women aged 18 - 45 years old
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

1. History of estrogen, progestin or testosterone use within 3 months
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7)	Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7)	-
Estetrol 15 mg/Drospirenone 3 mg (24/4)	Estetrol 15 mg/Drospirenone 3 mg (24/4)	-

Primary Outcome Measures

Name	Time	Method
Rate of ovulation inhibition and classify ovarian activities using transvaginal ultrasound	34-36 days	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

Secondary Outcome Measures

Name	Time	Method
Level of serum hormonal profiles: Estradiol, Progesterone, LH	Cervical mucus classification	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.
Cervical mucus	34-36 days	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

Trial Locations

Locations (1)

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand