"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 | Completed DMC

• 1 other identifier: IRB0838/66
• Study Type: interventional
• Target: 40
• 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: 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

Keywords

Quick starting contraception; Quadriphasic combined hormonal contraceptive pill(s); Estradiol valerate/Dienogest; 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

  34-36 days

• Cervical mucus classification

  34-36 days

Study Arms (2)

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

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

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

Interventions

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

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

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

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
• Sex: 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

MeSH Terms

Interventions

dienogest; Ethinyl Estradiol; Gestodene

Intervention Hierarchy (Ancestors)

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

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: Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7) as control group Quadriphasic Estradiol valerate 1 - 3 mg/ Dienogest 2 - 3 mg (26/2) as intervention group

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 2, 2024
• Study Start: May 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: May 14, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)