NCT05360576

An Open-label, Randomized, 2-Period, Crossover, Pharmacokinetics Study

An Open-label, Randomized, 2-Period, Crossover Study to Assess the Comparative Pharmacokinetics of LSP-5415 and NuvaRing® in Healthy Adult Females

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Lupin Research Inc · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

An Open-label, Randomized, 2-Period, Crossover Study to Assess the Comparative Pharmacokinetics of LSP-5415 and NuvaRing® in Healthy Adult Females

Detailed description

This is an open-label, randomized-sequence, two-period, single-center, crossover, pharmacokinetic study in 40 healthy adult female subjects (18- 40 years). All subjects will receive LSP-5415 (28 days) and NuvaRing (28 days) under fasted conditions. There will be a 28-day washout period after ring removal in Treatment Period 1 and ring insertion in Treatment Period 2.

Conditions

• Pregnancy Prevention

Interventions

Type	Name	Description
DRUG	LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring)	To prevent pregnancy
DRUG	NuvaRing Vaginal Ring	To prevent pregnancy

Timeline

• Start date: 2022-02-24
• Primary completion: 2022-07-04
• Completion: 2022-07-04
• First posted: 2022-05-04
• Last updated: 2022-07-19

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated drug study