CompletedPhase 1

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

Egypt26 participantsStarted 2025-11-10

Plain-language summary

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

Age range40 Years – 70 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. For women ≥55 years old: At least twelve (12) months since their last menstrual period
✓. For women \< 55 years old: At least twelve (12) months since their last menstrual period and have a follicle stimulating hormone (FSH) level in the postmenopausal range.

Cmax

Timeframe: 72 hours

AUC0-T

Timeframe: 72 hours

NCT IDNCT07495007

SponsorZi Diligence Biocenter

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-28