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"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

NCT06396208 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-14

No results posted yet for this 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.

Conditions

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

Interventions

DRUG

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

Completing a pack (28 pills) of Quadriphasic Estradiol valerate 1 - 3 mg/ Dienogest 2 - 3 mg (26/2), starting on day 7-9 of menstrual cycle

DRUG

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

Completing a pack (28 pills) of Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7), starting on day 7-9 of menstrual cycle

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Somsook Santibenchakul, Master · Obstetric and gynecology department, Faculty of medicine, Chulalongkorn University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06396208 on ClinicalTrials.gov