NCT05461573

Efficacy, Safety, and Tolerability of LPRI-CF113 as an Oral Contraceptive in Females

A Phase 3, Multi-Center, Non-Comparative Study to Evaluate the Contraceptive Efficacy, Safety, and Tolerability of LPRI-CF113 Administered Orally for 13 Medication Cycles

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,542 (actual)
• Sponsor: Insud Pharma · Industry
• Sex: Female
• Age: 13 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will be in two parts, Part A and Part B. The primary objective of Part A is to evaluate the contraceptive efficacy of LPRI-CF113. The secondary objective of Part A is to evaluate the safety and tolerability of LPRI-CF113. The primary objective of Part B is to evaluate the impact of LPRI-CF113 on bone mineral density (BMD) at the lumbar spine (L1-L4) after 12 months (13 medication cycles). The secondary objective of Part B is to evaluate the impact of LPRI-CF113 on BMD and bone turnover after 12 months (13 medication cycles) at the femoral neck, total hip, and total body.

Detailed description

This is a Phase 3, prospective, multi-center, open-label, non-comparative study in female subjects 13 to 45 years of age (inclusive) to determine the efficacy, safety, and tolerability of LPRI-CF113 administered orally for 13 (28-day) medication cycles (Part A). Healthy, sexually active female subjects of childbearing potential, who present to the clinic seeking contraception, will be enrolled in the study. Part B will be an investigation of bone mineral density (BMD) at the lumbar spine and BMD and bone turnover at the femoral neck, total hip, and total body. Part B will consist of a subgroup of subjects enrolled in Part A (i.e., subjects that meet all of Part A inclusion criteria and none of Part A AND Part B exclusion criteria) who are 18 to 45 years of age (inclusive at the time of screening). BMD will be assessed by dual-energy X-ray absorptiometry (DXA) scan. The study duration (Parts A and B) for each subject will be up to approximately 404 days (28 days \[screening\] + 376 days \[Treatment and Follow-up Period\]), unless the subject meets criteria for the extended Part B Follow-up, in which the duration will be approximately 769 days (28 days \[screening\] + 376 days \[Treatment and Follow-up Period\] + 365 days \[extended Part B Follow up\]).

Conditions

• Contraception
• Change in Bone Mineral Density

Interventions

Type	Name	Description
DRUG	Drospirenone	LPRI-CF113 consists of 24 active white tablets containing drospirenone (DRSP) 4 mg followed by 4 active pink tablets containing DRSP 2.8 mg, taken orally once daily for 28 consecutive days, in consecutive cycles for 12 months (13 medication cycles) without a break in daily tablet intake.

Timeline

• Start date: 2022-08-02
• Primary completion: 2024-08-05
• Completion: 2025-05-27
• First posted: 2022-07-18
• Last updated: 2025-10-08

Locations

47 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study