"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

NCT06396221 | Completed DMC

• 1 other identifier: IRB0839/66
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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. 1.Does Estetrol/Drospirenone inhibit ovulation inferior to Ethinyl estradiol/Gestodene when starting on Day 7-9 of menstrual cycle?
2. 2.What are the impacts of Estetrol/Drospirenone on ovarian activities when starting on Day 7-9 of menstrual cycle?
3. 3.How does the cervical mucus change when starting Estetrol/Drospirenone on Day 7-9 of menstrual cycle?
4. 4.What are the adverse effects when starting Estetrol/Drospirenone on Day 7-9 of menstrual cycle?

Conditions

Ultrasound Finding: Ovulation Inhibition, Ovarian Activities; Cervical Mucus; Serum Hormonal Profile

Keywords

Quick starting contraception; Estetrol 15 mg and Drospirenone 3 mg; Estetrol/Drospirenone; Ovulation inhibition

Outcome Measures

Primary Outcomes (1)

• 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

  34-36 days

Secondary Outcomes (2)

• Level of serum hormonal profiles: Estradiol, Progesterone, LH

  Cervical mucus classification

• Cervical mucus

  34-36 days

Study Arms (2)

Estetrol 15 mg/Drospirenone 3 mg (24/4)

EXPERIMENTAL

Drug: Estetrol 15 mg/Drospirenone 3 mg (24/4)

Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7)

ACTIVE COMPARATOR

Drug: Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7)

Interventions

Estetrol 15 mg/Drospirenone 3 mg (24/4) DRUG

Completing a pack (28 pills) of Estetrol 15 mg/Drospirenone 3 mg (24/4), starting on day 7-9 of menstrual cycle

Estetrol 15 mg/Drospirenone 3 mg (24/4)

Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7) DRUG

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)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

Related Publications (1)

• Ittipuripat S, Phutrakool P, Uaamnuichai S, Porntawansak G, Wongwathanavikrom R, Utaipatanacheep P, Santibenchakul S. Delayed start of estetrol drospirenone versus ethinyl estradiol gestodene for ovulation inhibition in a noninferiority randomized controlled trial. Sci Rep. 2025 Dec 12;15(1):43682. doi: 10.1038/s41598-025-27467-y.

  PMID: 41388035 DERIVED

MeSH Terms

Interventions

Estetrol; drospirenone; Ethinyl Estradiol; Gestodene

Intervention Hierarchy (Ancestors)

Estriol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Norpregnatrienes; Norpregnanes; Norsteroids; Estrogenic Steroids, Alkylated

Study Officials

• Somsook Santibenchakul, Master

  Obstetric and gynecology department, Faculty of medicine, Chulalongkorn University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7) as control group 2. Estetrol 15 mg/Drospirenone 3 mg (24/4) as intervention group

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 2, 2024
• Study Start: May 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 20, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)