NCT05360550

A Study to Evaluate the Effect of a Contraceptive Vaginal Ring LSP- 5415 on Ovarian Function in Healthy Adult Females

A Study to Evaluate the Effect of a Contraceptive Vaginal Ring LSP- 5415 Releasing Ethinyl Estradiol Plus Etonogestrel on Ovarian Function in Healthy Adult Females

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Lupin Research Inc · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Pregnancy Prevention

Interventions

Type	Name	Description
DRUG	LSP-5415	pregnancy prevention

Timeline

• Start date: 2022-07-05
• Primary completion: 2023-01-12
• Completion: 2023-01-12
• First posted: 2022-05-04
• Last updated: 2023-03-09

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated drug study