ContraceptionPhase 4NCT03531437
Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT
A Phase 4 study testing 1.5 mg estradiol and 2.5 mg nomegestrol acetate and 15 µg ethinylestradiol and 60 µg gestodene in people with Contraception and Hypercoagulability, run by Mahidol University.
Trial summary
The purpose of this study is to compare the effects of Zoely® and Minidoz® on hemostatic profiles Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Hypercoagulability
- What is being tested?
- 1.5 mg estradiol and 2.5 mg nomegestrol acetate and 15 µg ethinylestradiol and 60 µg gestodene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to 18 Apr 2018
- Phase
- Phase 4
- 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 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Woman age 19-40 yr
- Normal uterus and both adnexae
- BMI < 28.5 kg/m2
- Require contraception with COCs
Who cannot join
- Pregnancy
- Postartum period within 6 wk
- Smoking
- BP ≥ 140/90 mmHg
- Contraindication to COCs : VTE, cerebrovascular disease, cardiovascular disease, migraine with aura, hepatitis, undiagnosed abnormal uterine bleeding, CA breast, DM with DN/DR
- use of liver-enzyme-inducing drugs, drugs affecting the haemostatic system
- Use contraceptive steroids within 3 months
About this study
Official title: Comparison of Coagulation Profiles in Oral Contraceptive Pills Users Between 1.5 mg Estradiol/2.5 mg Nomegestrol Acetate (Zoely) and 15 mcg Ethinylestradiol/60 mcg Gestodene (Minidoz): A Randomized Control Trial
The purpose of this study is to compare the effects of Zoely® and Minidoz® on hemostatic profiles
Read the detailed description
compare the effects of Zoely® and Minidoz® on hemostatic profiles : D-dimer, Antithrombin and fibrinogen
- Conditions
- Contraception, Hypercoagulability
- Being tested
- 1.5 mg estradiol and 2.5 mg nomegestrol acetate, 15 µg ethinylestradiol and 60 µg gestodene
- Medical subject headings
- Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.5 mg estradiol and 2.5 mg nomegestrol acetateDrug
Also called Zoely®
15 µg ethinylestradiol and 60 µg gestodeneDrug
Also called Minidoz®
| Study group | Role | What they receive |
|---|---|---|
| Zoely | Active comparator | Monophasic combined oral contraceptive pills 24 white active tablets and 4 yellow inactive tablets each active tablet contains 1.5 mg estradiol and 2.5 mg nomegestrol acetate 3 cycles Receives: Drug: 1.5 mg estradiol and 2.5 mg nomegestrol acetate |
| Minidoz | Active comparator | Monophasic combined oral contraceptive pills 24 active tablets and 4 inactive tablets each active tablet contains ethinylestradiol 15 µg and gestodene 60 µg 3 cycles Receives: Drug: 15 µg ethinylestradiol and 60 µg gestodene |
What is being measured
The primary outcome is the main question the study is designed to answer.
D-dimer
µg/L
Measured: 12 weeks
Secondary outcomes (3)
fibrinogen
mg/dL
Measured: 12 weeks
antithrombin III
percent
Measured: 12 weeks
to access menstrual cycle and bleeding pattern, side effects of Zoely® and Minidoz®
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study startMar 2016
- Primary completionJan 2018
- Study completion18 Apr 2018
Why it stopped: problem with recruiting participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Mahidol 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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nalinee Panichyawat, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531437
- Sponsor's protocol ID
- 656/2558 (Si726/2015)
- Status last verified
- May 2018
- First submitted
- 11 Jan 2016
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Coagulation Profiles in Oral Contraceptive Pills Users Between 1.5 mg Estradiol/2.5 mg Nomegestrol Acetate (Zoely) and 15 mcg Ethinylestradiol/60 mcg Gestodene (Minidoz): A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03531437
- Acronym / sponsor ID
- 656/2558 (Si726/2015)
- Conditions
- Contraception, Hypercoagulability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: problem with recruiting participants
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 21 May 2018 (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 purpose of this study is to compare the effects of Zoely® and Minidoz® on hemostatic profiles
Detailed description
compare the effects of Zoely® and Minidoz® on hemostatic profiles : D-dimer, Antithrombin and fibrinogen
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zoely | Active comparator | Drug: 1.5 mg estradiol and 2.5 mg nomegestrol acetateMonophasic combined oral contraceptive pills 24 white active tablets and 4 yellow inactive tablets each active tablet contains 1.5 mg estradiol and 2.5 mg nomegestrol acetate 3 cycles |
| Minidoz | Active comparator | Drug: 15 µg ethinylestradiol and 60 µg gestodeneMonophasic combined oral contraceptive pills 24 active tablets and 4 inactive tablets each active tablet contains ethinylestradiol 15 µg and gestodene 60 µg 3 cycles |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Woman age 19-40 yr
- Normal uterus and both adnexae
- BMI < 28.5 kg/m2
- Require contraception with COCs
Key exclusion criteria (7 listed)
- Pregnancy
- Postartum period within 6 wk
- Smoking
- BP ≥ 140/90 mmHg
- Contraindication to COCs : VTE, cerebrovascular disease, cardiovascular disease, migraine with aura, hepatitis, undiagnosed abnormal uterine bleeding, CA breast, DM with DN/DR
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 |
|---|---|---|
| 1.5 mg estradiol and 2.5 mg nomegestrol acetateAlso: Zoely® | Drug | Zoely |
| 15 µg ethinylestradiol and 60 µg gestodeneAlso: Minidoz® | Drug | Minidoz |
Primary outcome
D-dimer
Time frame: 12 weeks
µg/L
3 secondary outcomes
fibrinogen
Time frame: 12 weeks
antithrombin III
Time frame: 12 weeks
to access menstrual cycle and bleeding pattern, side effects of Zoely® and Minidoz®
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: problem with recruiting participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1.5 mg estradiol and 2.5 mg nomegestrol acetate and 15 µg ethinylestradiol and 60 µg gestodene in people with Contraception and Hypercoagulability, run by Mahidol University.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: problem with recruiting participants). Results are not available in the source record.
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?
D-dimer (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2018.