"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

Last updated: August 20, 2024
Sponsor: Chulalongkorn University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

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

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

Clinical Study ID

NCT06396221
IRB0839/66
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 compatibleswith U.S. medical eligibility criteria category 3 - 4

  5. Consent to use condom as contraception or have been sterilized

Exclusion

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

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Estetrol 15 mg/Drospirenone 3 mg (24/4)
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
April 30, 2025

Study 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.

Connect with a study center

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330
    Thailand

    Active - Recruiting

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