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

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.

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:

  1. For women ≥55 years old: At least twelve (12) months since their last menstrual period
  2. 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:

Note: Results of laboratory investigations within laboratory reference ranges (ALP and creatinine are accepted if below the reference range after being evaluated by the physician as clinically not significant).

Note: Results of Hematologic tests are accepted if within 5% of reference limits after being evaluated by the physician as clinically not significant.

Note: All laboratory tests performed must be evaluated by the investigator; as a normal or medically insignificant. Otherwise if the result is abnormal medically significant then the result could be confirmed by a new sample. Once the result is confirmed to be abnormal medically significant the participant must be excluded Laboratory Tests Biochemistry Random Blood Sugar, Serum Urea, Serum Creatinine, Alanine Amino Transferase (ALT/GPT), Aspartate Amino Transferase (AST/GOT), Total Bilirubin (serum), Alkaline Phosphatase (serum).

Hematology White blood count, red blood cell count, Hemoglobin, Hematocrit, MCV, MCH, MCHC, Platelets. Urine analysis Specific Gravity, pH, Protein, Glucose, Ketones, Nitrite, Red cells, Pus cells.

Serology HIV, Hepatitis B, Hepatitis C. Other Pregnancy test for females, ABO blood group, RH and (FSH for post-menopausal women less than 55 years and with last menstrual period less than 12 months)

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.
  • 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.
  • Refusal to abstain from food for at least ten hours before dosing.
  • Refusal to abstain from alcohol or methylxanthine-containing beverages or foods (coffee, tea, carbonated drinks, chocolate) from 2 days prior to dosing till last sample collection.
  • Participants with a positive test for HBs-Ag, HIV-Ab, or HCV-Ab
  • Participant with positive drug abuse test in urine at the time of check-in.
  • Evidence of an uncooperative attitude.

Post-menopausal women

Might be shared if requested

Analysts are masked