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NCT Number: NCT06396221

"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

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

About this study

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

  • Transvaginal ultrasound
  • Cervical mucus
  • Serum hormonal profiles.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Rate of ovulation inhibition and classify ovarian activities using transvaginal ultrasound

    Time frame: 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 outcomes

  1. Level of serum hormonal profiles: Estradiol, Progesterone, LH

    Time frame: 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.

  2. Cervical mucus

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

"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: A Single-blind, Randomized Controlled, Non-inferiority Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 2, 2024
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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