NCT07495007

An Open-label, Randomized, Single-dose, Two-treatment, Four-period, Fully Replicate Crossover Bioequivalence Study in Healthy Female Adult Participants Under Fasting Conditions Comparing the Test Product, Prontogest Solution for IM Injection With the Reference Product, Progesterone Injection

An Open-label, Randomized, Single-dose, Two-treatment, Four-period, Fully Replicate Crossover Bioequivalence Study in Healthy Female Adult Participants Under Fasting Conditions Comparing the Test Product, Prontogest 100mg/2mL Solution for IM Injection With the Reference Product, Progesterone Injection, USP 500mg Per 10mL.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Zi Diligence Biocenter · Industry
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Bioequivalence study of two injectable formulation of progesterone in healthy post-menopausal women

Detailed description

An open-label, randomized, single-dose, two-treatment, four-period, fully replicate crossover bioequivalence study in healthy female adult post-menopausal participants under fasting conditions comparing the test product, Prontogest 100mg/2mL Solution for IM injection with the reference product, Progesterone Injection, USP 500mg per 10mL.

Conditions

• Bioequivalance
• Post-menopause

Interventions

Type	Name	Description
DRUG	Progesterone IM of 100 mg	Test Product
DRUG	Progesterone IM of 100 mg	Reference product

Timeline

• Start date: 2025-11-10
• Primary completion: 2025-12-28
• Completion: 2025-12-28
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: Egypt