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

NCT07495007 | Completed Phase 1

• 2 other identifiers: Pro25085Zi-Pro/Mar-0925-58
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bioequivalance; Post-menopause

Keywords

Bioequivalence; Zi-Diligence; Post-menopause; progesterone injection; baseline correction; Zi Diligence Biocenter

Outcome Measures

Primary Outcomes (2)

• Cmax

  Determine Bioequivalence for Cmax

  72 hours

• AUC0-T

  Determine Bioequivalence for AUC0-T

  72 hours

Secondary Outcomes (3)

• Tmax

  72 hours

• Kel

  72 hours

• Half life

  72 hours

Study Arms (2)

RTRT

OTHER

sequence of crossover design

Drug: Progesterone IM of 100 mg

TRTR

OTHER

sequence of crossover design

Drug: Progesterone IM of 100 mg

Interventions

Progesterone IM of 100 mg DRUG

Test Product

Also known as: Prontogest ampoule

RTRT; TRTR

Eligibility Criteria

• Age: 40 Years - 70 Years
• Gender Eligibility Details: Post-menopausal women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Blood Pressure: Systolic 100-130 mmHg, Diastolic 70-90 mmHg.
• Pulse Rate: 60-100 beats per minute (bpm).
• Body Temperature: 36.1-37.2 ºC. Note: Corrective treatment may be provided at the discretion of the Principal Investigator (PI) or Co-Investigator for participants with blood pressure below 90/60 mmHg. If the participant does not respond to treatment, they will be excluded from the study.
• Participants must have a normal ECG as assessed by the PI /delegated medical professional.
• A normal physical examination at the screening visit without specific abnormalities
• No significant medical or surgical history of illness within the last 4 weeks prior to the start of the study, as determined by the Investigator.
• Participants with clinically acceptable laboratory investigations mentioned in the Table below:

You may not qualify if:

• 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.
• History or presence of heavy smoking (≥10 cigarettes or consumption of tobacco products and refusal to restrain from smoking or consumption of tobacco products for 48.00 hours before dosing until checkout of the study).
• History or presence of significant renal, hepatobiliary, or liver impairment; a medical or familial history of seizures; significant asthma, urticaria, or other allergic reactions; or any other significant medical condition as determined by the Principal Investigator or their delegate.
• History of difficulty with donating blood or difficulty in accessibility of veins
• Use of any prescribed medication or OTC medicines or herbal medicines during the last one week preceding the first dosing.
• Participants who have any food allergy, intolerance, restriction or special diet during the four weeks before screening.
• Participation in a drug research study within past 2 months from the planned day of first dose injection.
• Donation of blood in the past 2 months before screening.

Sponsors & Collaborators

• Zi Diligence Biocenter: lead
• Marcyrl Pharmaceutical Industries: collaborator

Study Sites (1)

Zi Diligence Biocenter

Cairo, Cairo Governorate, 19653, Egypt

Location

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Eman Nouman, PhD, Analytical Chemistry

  Zi Diligence Biocenter

  STUDY DIRECTOR

• Amira Gouda, PhD Analytical Chemistry

  Zi Diligence Biocenter

  STUDY CHAIR

• Mostafa Salah, MSc, Pharmacology & Toxicology

  Zi Diligence Biocenter

  STUDY CHAIR

• Mohammed Abdulhafez, MBBCH

  Zi Diligence Biocenter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Analysts are masked
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Full replicate cross-over Bioequivalence study

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 27, 2026
• Study Start: November 10, 2025
• Primary Completion: December 28, 2025
• Study Completion: December 28, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)