NCT07714616 Cyproterone Acetate Contraception Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07714616 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.

MCP evidence snapshot: 21 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.

Why NCT07714616 is a hot trial to watch

Contraception is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07714616 is notable because it evaluates Cyproterone Acetate in a Phase 3 design sponsored by Eurofarma Laboratórios SA. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.

Trial landscape snapshot

Protocol design and endpoint interpretation

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 o

Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of 1600 participants across Not reported in the indexed record shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.

• Contraceptive Efficacy Assessed by Pearl Index in Participants Aged ≤35 Years (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.

Readout outlook and evidence gap

The current protocol points to 2029-05-31 as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.

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Asset and sponsor context

Trial-sourced asset: Cyproterone Acetate. The Drug & Asset MCP enrichment step is designed to add normalized targets, modality and global development status when an exact asset match is available.

Trial-sourced sponsor: Eurofarma Laboratórios SA. Company & Deal Intelligence MCP is the companion workflow for resolving organization identity, corporate profile and partnering context.

The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.

White space around this program

• Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
• Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
• Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
• Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
• Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.

What to monitor next

Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.

Bottom line

NCT07714616 provides a focused lens on Contraception development. Its value will be determined by whether Cyproterone Acetate can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.

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