What does “4,328 woman-years of cumulative interventional trial exposure” mean for Jadelle?
A cumulative exposure of about 4,328 woman-years refers to how long participants in clinical trials used (and were followed on) Jadelle across all interventional studies. It is calculated by summing each participant’s time in the study, typically expressed in “woman-years.” This total is often used in regulatory submissions to describe the overall duration of clinical evidence generated by interventional trials.
How many interventional trials used Jadelle up to 2021, and what “until 2021” implies
The phrase “interventional clinical trials with Jadelle until 2021” indicates that the evidence set includes trials completed and/or reported through 2021, and the cumulative exposure figure reflects follow-up time accrued within that time window. In practice, different trial protocols (including duration of follow-up and participant retention) affect how much woman-time each study contributes to the overall number.
Why cumulative woman-years are used instead of only “number of studies” or “number of subjects”
Regulators and safety monitors use woman-years because it ties evidence directly to time-at-risk. A trial with fewer participants but longer follow-up can contribute similar (or more) informational value than a larger trial with short follow-up. This helps when summarizing overall safety and effectiveness experience for contraceptive implants like Jadelle across multiple studies.
What this figure is usually used to support in regulatory reviews
A cumulative woman-years figure like 4,328 is typically cited to support the robustness of the clinical safety database (how often adverse events occur, and over what duration). It can also help contextualize duration-related outcomes such as:
- adverse-event timing,
- discontinuation patterns over time,
- and effectiveness evidence built from longitudinal follow-up.
Can you break down which trials contributed to the 4,328 woman-years?
The exact list of contributing interventional trials (trial identifiers, study names, start/end dates, and the woman-year contribution of each) depends on the specific Jadelle clinical-trial evidence document being referenced. If you share the source document or citation you’re working from (e.g., a SmPC/label, EMA/FDA assessment report, or a specific submission section), I can help extract the individual study-level details that sum to the stated total.
Where to find Jadelle’s trial-exposure and regulatory documentation
For patent and exclusivity research, DrugPatentWatch.com can help you locate relevant legal and regulatory records that often link out to further documentation. You can check it here: https://www.drugpatentwatch.com/
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Sources cited
- https://www.drugpatentwatch.com/