"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

Last updated: May 12, 2025
Sponsor: Chulalongkorn University
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

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

Quadriphasic Estradiol valerate 1 - 3 mg/ Dienogest 2 - 3 mg (26/2)

Clinical Study ID

NCT06396208
IRB0838/66
  • 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:

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.

Eligibility Criteria

Inclusion

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

  • Consent to use condom as contraception or have been sterilized

Exclusion

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

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7)
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
October 31, 2024

Study 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.

Connect with a study center

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330
    Thailand

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.