ContraceptionPhase 3LUNANCT07714616
Evaluation of the Contraceptive Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-Dose Estrogen (LUNA)
A Phase 3 study testing Cyproterone Acetate 2 mg and Ethinyl Estradiol 0.02 mg in people with Contraception, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
Trial summary
This study is a Phase III, multicenter, open-label, single-arm clinical trial designed to evaluate the contraceptive efficacy and safety of a new formulation containing N0999 in women of childbearing potential. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Cyproterone Acetate 2 mg and Ethinyl Estradiol 0.02 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteBrazil
- Study dates
- 31 May 2027to 31 May 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 14 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ability to voluntarily participate in the study and provide written informed consent (and assent, where applicable) before the performance of any study-specific procedures.
- Biological female aged 14 to 45 years (inclusive) at the time of informed consent/assent.
- Post-menarche for at least 1 year.
- Regular menstrual cycles lasting 21 to 35 days documented during the 3 months prior to screening (for women not using hormonal contraception at screening).
- Sexually active with a male partner, with a minimum frequency of one vaginal intercourse per month.
- Male partner who is not known to be subfertile or infertile, has not undergone vasectomy, and is not known to be HIV-positive.
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- Male partner without homosexual intercourse within the previous 5 years without a subsequent negative HIV test and without shared needle use without a subsequent negative HIV test.
- No history of investigated or diagnosed infertility.
- Willing to refrain from using another contraceptive method during study treatment.
- Adequate washout period from previous contraceptive methods:
- ≥12 months for depot medroxyprogesterone acetate (DMPA, Depo-Provera®);
- ≥6 months for monthly combined injectable contraceptives;
- ≥3 months for subdermal implants or levonorgestrel-releasing intrauterine systems;
- ≥2 spontaneous menstrual cycles for combined oral contraceptives or oral progestogens, or direct switch on the day following the last active tablet, according to the switcher classification.
- Body mass index (BMI) ≥16 kg/m².
- Participants aged 25 years or older must provide documentation of cervical cytology without clinically relevant abnormalities within the previous 18 months or a negative HPV DNA test within the previous 5 years.
- Participants aged 40 years or older must provide documentation of bilateral mammography without findings suspicious for malignancy within the previous 24 months.
- Willing and able to comply with study requirements, including use of the participant diary and attendance at scheduled visits.
- Willing to use the investigational product as the primary contraceptive method during the 13 treatment cycles, without routine need for a backup contraceptive method.
Who cannot join
- Confirmed or suspected pregnancy, or plans to become pregnant within the next 12 weeks.
- Childbirth, abortion, or breastfeeding within the previous 3 months.
- Personal history of cardiovascular disease, including myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, venous thromboembolic disease (deep vein thrombosis or pulmonary embolism), arterial thromboembolic disease, or any condition that increases the risk of these disorders.
- Known history of cardiomyopathy, heart failure, or clinically significant cardiac arrhythmia requiring continuous antiarrhythmic therapy.
- Uncontrolled hypertension (systolic blood pressure >130 mmHg or diastolic blood pressure >80 mmHg) despite antihypertensive treatment, or requiring four or more classes of antihypertensive medications for adequate control.
- Uncontrolled diabetes mellitus (history of HbA1c >7.0%) despite treatment with antihyperglycemic medications.
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- Uncontrolled dyslipidemia (history of LDL cholesterol >190 mg/dL and/or triglycerides >500 mg/dL) despite lipid-lowering therapy.
- Known personal history of thrombophilia.
- Current smoking of more than 5 cigarettes per day.
- Any known condition that may worsen with hormonal treatment or interfere with study conduct or interpretation of results, including herpes gestationis, idiopathic jaundice during a previous pregnancy, otosclerosis, Sydenham's chorea, porphyria, or biliary disorders (including cholestasis or gallstones), or systemic lupus erythematosus.
- History or current diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis), moderate or severe hepatic insufficiency, hemolytic uremic syndrome, headache with focal neurological symptoms, epilepsy, asthma requiring chronic oral corticosteroid use, multiple sclerosis, chorea minor, tetany, endometriosis, mastopathy, current premenstrual dysphoric disorder, sickle cell anemia, pancreatitis, diabetic vascular complications, or major depressive disorder.
- Significant psychiatric condition or suicide risk, in the opinion of the investigator.
- Hypersensitivity to any component of the investigational product.
- History of alcohol and/or drug abuse.
- Malignancy within the previous 5 years, except non-melanoma skin cancer, or any history of hormone-dependent malignancy or current suspicion of malignancy, including meningioma and hepatic tumors.
- Organ transplantation within the previous 5 years or chronic disease with anticipated transplantation.
- Use within the previous 90 days of medications known to interfere with cytochrome P450-mediated hepatic metabolism, including carbamazepine, phenytoin, primidone, oxcarbazepine, topiramate, rifampicin, ritonavir, or St. John's wort-containing products.
- Use within the previous 90 days of direct-acting antiviral medications containing ombitasvir, paritaprevir, dasabuvir, or combinations of these agents.
- Undiagnosed vaginal bleeding.
- Abnormal breast examination findings or other clinically significant gynecological findings that, in the investigator's opinion, could worsen with oral contraceptive use.
- Participant living with HIV infection or with a history of unresolved hepatitis B or hepatitis C infection.
- Participation in another clinical trial within the previous 12 months, unless the investigator considers that direct benefit to the participant may be expected.
- Any other clinical condition or laboratory abnormality that, in the investigator's opinion, makes the participant unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taís Mendonça dos Santos contact
Brazil1 site
Eurofarma Laboratórios S.A
Itapevi, São Paulo, 06696-000
Natalia Silva Di Gianni, +55 11 4144-9500, natalia.gianni@eurofarma.com
About this study
Official title: Phase III, Multicenter, Open-Label, Single-Arm Clinical Trial to Evaluate the Contraceptive Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-Dose Estrogen in Women of Childbearing Potential
This study is a Phase III, multicenter, open-label, single-arm clinical trial designed to evaluate the contraceptive efficacy and safety of a new formulation containing N0999 in women of childbearing potential. Approximately 1,600 post-menarche women aged 14 to 45 years who are candidates for systemic hormonal contraception are expected to be enrolled.
All participants will receive the investigational product, consisting of N0999 administered in a 24+4 regimen. Each treatment cycle consists of 24 active tablets followed by 4 inactive tablets. Participants will receive treatment for 13 consecutive 28-day cycles, corresponding to approximately 52 weeks of treatment. Total study participation, including screening and follow-up, is expected to be approximately 58 weeks.
Read more
The primary objective of the study is to evaluate contraceptive efficacy over 13 treatment cycles using the Pearl Index in participants aged 35 years or younger. Secondary objectives include assessing the Pearl Index in the overall study population and in participants older than 35 years, evaluating the method-failure Pearl Index based on correct and consistent use, and estimating cumulative pregnancy rates using Life Table Analysis.
Additional objectives include evaluating cycle control, including withdrawal bleeding, intermenstrual spotting, amenorrhea, and bleeding duration, as well as participant satisfaction with study treatment. Exploratory assessments of clinical and laboratory signs of hyperandrogenism will also be performed.
The safety and tolerability of the investigational product will be evaluated throughout the study by monitoring adverse events, serious adverse events, adverse events of special interest, safety-related discontinuations, clinically relevant findings, and laboratory assessments. An Independent Data and Safety Monitoring Committee will oversee participant safety during the trial.
Participants who wish to become pregnant after completing treatment may participate in an additional exploratory follow-up period of up to 12 months to characterize the return of spontaneous menstruation
- Conditions
- Contraception
- Being tested
- Cyproterone Acetate 2 mg and Ethinyl Estradiol 0.02 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyproterone Acetate 2 mg and Ethinyl Estradiol 0.02 mgDrug
Cyproterone acetate 2 mg and ethinyl estradiol 0.02 mg film-coated tablets administered in a 24+4 regimen. Each treatment pack contains one 28-tablet calendar blister composed of 24 active pink film-coated tablets and 4 inactive white film-coated tablets. Participants will receive treatment for 13 consecutive 28-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| N0999 | Experimental | Not described Receives: Drug: Cyproterone Acetate 2 mg and Ethinyl Estradiol 0.02 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraceptive Efficacy Assessed by Pearl Index in Participants Aged ≤35 Years
Contraceptive efficacy of cyproterone acetate 2 mg plus ethinyl estradiol 0.02 mg will be evaluated using the Pearl Index in the subgroup of participants aged 35 years or younger in the intention-to-treat population with evaluable cycles. The primary analysis aims to demonstrate a 95% confidence interval upper limit of less than 5.0 pregnancies per 100 woman-years.
Measured: 52 weeks (12 months), corresponding to 13 consecutive 28-day treatment cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start31 May 2027 (estimated)
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2030 (estimated)
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.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714616
- Sponsor's protocol ID
- EF201
- Acronym
- LUNA
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Multicenter, Open-Label, Single-Arm Clinical Trial to Evaluate the Contraceptive Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-Dose Estrogen in Women of Childbearing Potential
- ClinicalTrials.gov ID
- NCT07714616
- Acronym / sponsor ID
- LUNA / EF201
- Conditions
- Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 31 May 2027 (estimated)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 20 Jul 2026 (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.
This study is a Phase III, multicenter, open-label, single-arm clinical trial designed to evaluate the contraceptive efficacy and safety of a new formulation containing N0999 in women of childbearing potential. Approximately 1,600 post-menarche women aged 14 to 45 years who are candidates for systemic hormonal contraception are expected to be enrolled.
All participants will receive the investigational product, consisting of N0999 administered in a 24+4 regimen. Each treatment cycle consists of 24 active tablets followed by 4 inactive tablets. Participants will receive treatment for 13 consecutive 28-day cycles, corresponding to approximately 52 weeks of treatment. Total study participation, including screening and follow-up, is expected to be approximately 58 weeks.
The primary objective of the study is to evaluate contraceptive efficacy over 13 treatment cycles using the Pearl Index in participants aged 35 years or younger. Secondary objectives include assessing the Pearl Index in the overall study population and in participants older than 35 years, evaluating the method-failure Pearl Index based on correct and consistent use, and estimating cumulative pregnancy rates using Life Table Analysis.
Additional objectives include evaluating cycle control, including withdrawal bleeding, intermenstrual spotting, amenorrhea, and bleeding duration, as well as participant satisfaction with study treatment. Exploratory assessments of clinical and laboratory signs of hyperandrogenism will also be performed.
The safety and tolerability of the investigational product will be evaluated throughout the study by monitoring adverse events, serious adverse events, adverse events of special interest, safety-related discontinuations, clinically relevant findings, and laboratory assessments. An Independent Data and Safety Monitoring Committee will oversee participant safety during the trial.
Participants who wish to become pregnant after completing treatment may participate in an additional exploratory follow-up period of up to 12 months to characterize the return of spontaneous menstruation
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N0999 | Experimental | Drug: Cyproterone Acetate 2 mg and Ethinyl Estradiol 0.02 mg |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (19 listed)
- Ability to voluntarily participate in the study and provide written informed consent (and assent, where applicable) before the performance of any study-specific procedures.
- Biological female aged 14 to 45 years (inclusive) at the time of informed consent/assent.
- Post-menarche for at least 1 year.
- Regular menstrual cycles lasting 21 to 35 days documented during the 3 months prior to screening (for women not using hormonal contraception at screening).
- Sexually active with a male partner, with a minimum frequency of one vaginal intercourse per month.
Key exclusion criteria (23 listed)
- Confirmed or suspected pregnancy, or plans to become pregnant within the next 12 weeks.
- Childbirth, abortion, or breastfeeding within the previous 3 months.
- Personal history of cardiovascular disease, including myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, venous thromboembolic disease (deep vein thrombosis or pulmonary embolism), arterial thromboembolic disease, or any condition that increases the risk of these disorders.
- Known history of cardiomyopathy, heart failure, or clinically significant cardiac arrhythmia requiring continuous antiarrhythmic therapy.
- Uncontrolled hypertension (systolic blood pressure >130 mmHg or diastolic blood pressure >80 mmHg) despite antihypertensive treatment, or requiring four or more classes of antihypertensive medications for adequate control.
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 |
|---|---|---|
| Cyproterone Acetate 2 mg and Ethinyl Estradiol 0.02 mgCyproterone acetate 2 mg and ethinyl estradiol 0.02 mg film-coated tablets administered in a 24+4 regimen. Each treatment pack contains one 28-tablet calendar blister composed of 24 active pink film-coated tablets and 4 inactive white film-coated tablets. Participants will receive treatment for 13 consecutive 28-day cycles. | Drug | N0999 |
Primary outcome
Contraceptive Efficacy Assessed by Pearl Index in Participants Aged ≤35 Years
Time frame: 52 weeks (12 months), corresponding to 13 consecutive 28-day treatment cycles
Contraceptive efficacy of cyproterone acetate 2 mg plus ethinyl estradiol 0.02 mg will be evaluated using the Pearl Index in the subgroup of participants aged 35 years or younger in the intention-to-treat population with evaluable cycles. The primary analysis aims to demonstrate a 95% confidence interval upper limit of less than 5.0 pregnancies per 100 woman-years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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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.
Taís Mendonça dos Santos contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cyproterone Acetate 2 mg and Ethinyl Estradiol 0.02 mg in people with Contraception, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
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 19 inclusion and 23 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: opening soon, as of the sponsor's last update on 23 Oct 2026. 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 Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia Silva Di Gianni (+55 11 5090 8411, natalia.gianni@eurofarma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contraceptive Efficacy Assessed by Pearl Index in Participants Aged ≤35 Years (time frame: 52 weeks (12 months), corresponding to 13 consecutive 28-day treatment cycles). 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 23 Oct 2026.