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Evaluation of the Contraceptive Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-Dose Estrogen (LUNA)

NCT07714616 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1600

Last updated 2026-07-21

No results posted yet for this study

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. 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

Conditions

  • Contraception

Interventions

DRUG

Cyproterone Acetate 2 mg and Ethinyl Estradiol 0.02 mg

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.

Sponsors & Collaborators

  • Eurofarma Laboratorios S.A.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2027-05-31
Primary Completion
2029-05-31
Completion
2030-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07714616 on ClinicalTrials.gov