---
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"
nct_id: NCT06396221
overall_status: COMPLETED
phase: NA
sponsor: Chulalongkorn University
study_type: INTERVENTIONAL
primary_condition: "Ultrasound Finding: Ovulation Inhibition, Ovarian Activities"
countries: Thailand
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06396221.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06396221"
ct_last_update_post_date: 2025-05-20
last_seen_at: "2026-05-12T07:26:45.614Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# "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

**Official 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

**NCT ID:** [NCT06396221](https://clinicaltrials.gov/study/NCT06396221)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 36
- **Lead Sponsor:** Chulalongkorn University
- **Conditions:** Ultrasound Finding: Ovulation Inhibition, Ovarian Activities, Cervical Mucus, Serum Hormonal Profile
- **Start Date:** 2024-05-01
- **Completion Date:** 2024-09-30
- **CT.gov Last Update:** 2025-05-20

## 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:

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.

## Detailed 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** Yes

```
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 compatibles with U.S. medical eligibility criteria category 3 - 4
5. Consent to use condom as contraception or have been sterilized

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
```

## Arms

- **Estetrol 15 mg/Drospirenone 3 mg (24/4)** (EXPERIMENTAL)
- **Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7)** (ACTIVE_COMPARATOR)

## Interventions

- **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

- **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

- **Level of serum hormonal profiles: Estradiol, Progesterone, LH** _(time frame: Cervical mucus classification)_
- **Cervical mucus** _(time frame: 34-36 days)_

## Locations (1)

- King Chulalongkorn Memorial Hospital, Bangkok, Thailand

## Recent Field Changes (last 30 days)

- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.king chulalongkorn memorial hospital|bangkok||thailand` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06396221.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06396221*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*