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Clinical Trial Summary

The primary objective of this study is to evaluate the inhibition of ovulation in Cohort #1 (Body Mass Index of ≥ 18 kg/m2 to ≤ 30 kg/m2) after contraceptive vaginal ring LSP-5415 application for 3 treatment cycles.


Clinical Trial Description

This is an open-label study to evaluate inhibition of ovulation during treatment with LSP-5415 over a period of 3 treatment cycles (approximately 3 months) in healthy female volunteers with a documented ovulatory cycle (pre-treatment cycle). The study will consist of two subject cohorts; Cohort #1 will consist of a total of 16 healthy women aged 18-35 years with a BMI of ≥ 18 kg/m2 to ≤ 30 kg/m2, Cohort #2 will consist of up to 10 healthy women aged 18-35 years with a BMI of > 30 kg/m2 to ≤ 35 kg/m2. The study will consist of 3 treatment cycles each consisting of a 26 day ring-insertion period followed by a 2-day ring-free period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05360550
Study type Interventional
Source Lupin Research Inc
Contact
Status Completed
Phase Phase 2
Start date July 5, 2022
Completion date January 12, 2023

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