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

What this trial studies

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

Conditions in scope

• Bioequivalance
• Post-menopause

Interventions

• Progesterone IM of 100 mg (Drug) — Test Product
• Progesterone IM of 100 mg (Drug) — Reference product

Who can join

Women only · Ages 40 Years to 70 Years · Accepts healthy volunteers.

Inclusion criteria

• Healthy Postmenopausal female volunteers 40-70 years of age who meet the following criteria:
• Negative serum pregnancy test
• Evidence of Post-Menopausal status confirmed by one of the following:
• 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.
• Note: Justification for design of eligibility criteria is detailed on Appendix (II).
• Body Mass Index between 18.5 and 30 kg/m2 and the body weight is above 45 kgs.
• Participants must have vital signs within the normal range, as defined below, measured at pre-dose:

Exclusion criteria

• Contraindications or hypersensitivity to Progesterone, or any of the formulation excipients or related group of drugs.
• The concurrent use of hormonal contraceptives history of IM injection abscess
• Pregnant, breastfeeding, planning to become pregnant, or pre-menopausal women
• Known or suspected breast cancer.
• Active arterial or venous thromboembolism, or severe thrombophlebitis or a history of these events.
• History of IM injection abscess.
• History or presence of any medical condition or disease according to the opinion of the principal Investigator.
• History or presence of significant alcoholism or drug abuse in the past one year.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE1
• Start date: 2025-11-10
• Primary completion: 2025-12-28
• Last update posted: 2026-03-27
• First posted: 2026-03-27

Sponsor & contact

Lead sponsor: Zi Diligence Biocenter (Industry)

Collaborators: Marcyrl Pharmaceutical Industries

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Cmax (72 hours)
  Determine Bioequivalence for Cmax
• AUC0-T (72 hours)
  Determine Bioequivalence for AUC0-T

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.