Ultrasound Finding: Ovulation Inhibition, Ovarian ActivitiesNCT06396221
"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 study testing Estetrol 15 mg/Drospirenone 3 mg (24/4) and Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7) in people with Ultrasound Finding: Ovulation Inhibition, Ovarian Activities and Cervical Mucus, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Finding: Ovulation Inhibition, Ovarian Activities, Cervical Mucus, Serum Hormonal Profile
- What is being tested?
- Estetrol 15 mg/Drospirenone 3 mg (24/4) and Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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 Estetrol/Drospirenone inhibit ovulation inferior to Ethinyl estradiol/Gestodene when starting on Day 7-9 of menstrual cycle?
- What are the impacts of Estetrol/Drospirenone on ovarian activities when starting on Day 7-9 of menstrual cycle?
- How does the cervical mucus change when starting Estetrol/Drospirenone on Day 7-9 of menstrual cycle?
- 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.
Read the 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
- Transvaginal ultrasound
- Cervical mucus
- Serum hormonal profiles.
- Conditions
- Ultrasound Finding: Ovulation Inhibition, Ovarian Activities, Cervical Mucus, Serum Hormonal Profile
- Being tested
- Estetrol 15 mg/Drospirenone 3 mg (24/4), Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7)
- Keywords
- Quick starting contraception, Estetrol 15 mg and Drospirenone 3 mg, Estetrol/Drospirenone, Ovulation inhibition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Estetrol 15 mg/Drospirenone 3 mg (24/4) | Experimental | Not described Receives: Drug: Estetrol 15 mg/Drospirenone 3 mg (24/4) |
| Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7) | Active comparator | Not described Receives: Drug: Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 34-36 days
Secondary outcomes (2)
Level of serum hormonal profiles: Estradiol, Progesterone, LH
Visit the clinic on day 1-2, day 7-9, and then every 2-7 days according to ultrasound finding
- Blood test to measure estrogen level in picogram/milliliter, progesterone level in nanogram/milliliter and LH level in International unit per liter
- Volunteers will be placed in a 5 ml clot activator tube and sent to the endocrinology laboratory medical operation center within 30 minutes after blood draw.
Measured: Cervical mucus classification
Cervical mucus
Visit the clinic on day 1-2, day 7-9, and then every 2-7 days according to ultrasound finding
- Using Tuberculin syringe 1 mL to suck cervical mucus from the endocervical canal (1 cm deep from external cervical os)
- Assess the results of cervical mucus collected immediately according to WHO 2010, consisting of volume (milliliter), viscosity, ferning appearance, Spinnbarkeit (centimeter), and cellularity (cell/high power field), under microscopy
Measured: 34-36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 May 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ultrasound Finding: Ovulation Inhibition, Ovarian ActivitiesStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7) as control group 2. Estetrol 15 mg/Drospirenone 3 mg (24/4) as intervention group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Somsook Santibenchakul, Master, Study director, Obstetric and gynecology department, Faculty of medicine, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396221
- Sponsor's protocol ID
- IRB0839/66
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ittipuripat S, Phutrakool P, Uaamnuichai S, Porntawansak G, Wongwathanavikrom R, Utaipatanacheep P, Santibenchakul S. Delayed start of estetrol drospirenone versus ethinyl estradiol gestodene for ovulation inhibition in a noninferiority randomized controlled trial. Sci Rep. 2025 Dec 12;15(1):43682. doi: 10.1038/s41598-025-27467-y.
PubMed 41388035
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06396221
- Acronym / sponsor ID
- IRB0839/66
- Conditions
- Ultrasound Finding: Ovulation Inhibition, Ovarian Activities, Cervical Mucus, Serum Hormonal Profile
- Keywords
- Quick starting contraception, Estetrol 15 mg and Drospirenone 3 mg, Estetrol/Drospirenone, Ovulation inhibition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Estetrol/Drospirenone inhibit ovulation inferior to Ethinyl estradiol/Gestodene when starting on Day 7-9 of menstrual cycle?
- What are the impacts of Estetrol/Drospirenone on ovarian activities when starting on Day 7-9 of menstrual cycle?
- How does the cervical mucus change when starting Estetrol/Drospirenone on Day 7-9 of menstrual cycle?
- 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
- Transvaginal ultrasound
- Cervical mucus
- Serum hormonal profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 1. Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7) as control group 2. Estetrol 15 mg/Drospirenone 3 mg (24/4) as intervention group
| Arm | Type | Receives |
|---|---|---|
| Estetrol 15 mg/Drospirenone 3 mg (24/4) | Experimental | Drug: Estetrol 15 mg/Drospirenone 3 mg (24/4) |
| Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7) | Active comparator | Drug: Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estetrol 15 mg/Drospirenone 3 mg (24/4)Completing a pack (28 pills) of Estetrol 15 mg/Drospirenone 3 mg (24/4), starting on day 7-9 of menstrual cycle | Drug | Estetrol 15 mg/Drospirenone 3 mg (24/4) |
| 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 | Drug | Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7) |
Primary outcome
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
2 secondary outcomes
Level of serum hormonal profiles: Estradiol, Progesterone, LH
Time frame: Cervical mucus classification
Cervical mucus
Time frame: 34-36 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Derived from this study: PubMed 41388035Ittipuripat S, Phutrakool P, Uaamnuichai S, Porntawansak G, Wongwathanavikrom R, Utaipatanacheep P, Santibenchakul S. Delayed start of estetrol drospirenone versus ethinyl estradiol gestodene for ovulation inhibition in a noninferiority randomized controlled trial. Sci Rep. 2025 Dec 12;15(1):43682. doi: 10.1038/s41598-025-27467-y.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Somsook Santibenchakul, Master study director
Obstetric and gynecology department, Faculty of medicine, Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Estetrol 15 mg/Drospirenone 3 mg (24/4) and Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7) in people with Ultrasound Finding: Ovulation Inhibition, Ovarian Activities and Cervical Mucus, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of ovulation inhibition and classify ovarian activities using transvaginal ultrasound (time frame: 34-36 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06396221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.