NCT03945513

A Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, and Tolerability of LPRI-424, 13 Cycles

A Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, and Tolerability of LPRI-424 (Dienogest 2 mg / Ethinyl Estradiol 0.02 mg) During 13 Cycles

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,034 (actual)
• Sponsor: Insud Pharma · Industry
• Sex: Female
• Age: 13 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main objective of this trial is to demonstrate the contraceptive efficacy of LPRI424, Additional goals of the trial are to demonstrate the safety and tolerability of LPRI424.

Detailed description

This trial is a prospective, multicenter, open-label, non-controlled trial in postmenarcheal and premenopausal female subjects, including adolescents, between the ages of 13 and 45 who present to the clinic seeking contraception. At screening, informed consent will be obtained and the screening procedures will be performed. After confirmation of the subject's eligibility, the subject will be provided with the investigational product and trained in the use of an electronic diary. Afterwards, the subjects will visit the clinical site on Day 20±3 of the 1st, 3rd, 6th and 9th cycles and on Day 29+3 of the 13th cycle. The last clinical site visit will occur 10-14 days after the 13th cycle visit. The trial will include women who have never used hormonal contraceptives before consent (naïve users), women who have used hormonal contraceptives in the past but have had a contraceptive-free period before consent and a full menstrual cycle during the drug-free period (previous users) as well as women directly switching from another hormonal method (switchers). Adverse events and safety information will be collected throughout the study.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	LPRI424 (dienogest/ethinylestradiol)	One LPRI424 tablet once per day for 24 days followed by 4 placebo tablets for 4 days equals one cycle.

Timeline

• Start date: 2019-12-03
• Primary completion: 2023-06-30
• Completion: 2023-09-08
• First posted: 2019-05-10
• Last updated: 2023-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study