BioequivalancePhase 1ProntogestNCT07495007
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
A Phase 1 study testing Progesterone IM of 100 mg in people with Bioequivalance and Post-menopause, run by Zi Diligence Biocenter at 1 site in Egypt.
Trial summary
Bioequivalence study of two injectable formulation of progesterone in healthy post-menopausal women Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalance, Post-menopause
- What is being tested?
- Progesterone IM of 100 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2025to 28 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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).
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- 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)
Who cannot join
- • 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Bioequivalence study of two injectable formulation of progesterone in healthy post-menopausal women
Read the 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
- Being tested
- Progesterone IM of 100 mg
- Keywords
- Bioequivalence, Zi-Diligence, Post-menopause, progesterone injection, baseline correction, Zi Diligence Biocenter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone IM of 100 mgDrug
Also called Prontogest ampoule
Test Product
Progesterone IM of 100 mgDrug
Also called Progesterone 100 mg/10ml
Reference product
| Study group | Role | What they receive |
|---|---|---|
| RTRT | Other | sequence of crossover design Receives: Drug: Progesterone IM of 100 mg |
| TRTR | Other | sequence of crossover design Receives: Drug: Progesterone IM of 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Determine Bioequivalence for Cmax
Measured: 72 hours
AUC0-T
Determine Bioequivalence for AUC0-T
Measured: 72 hours
Secondary outcomes (3)
Tmax
Compare Tmax
Measured: 72 hours
Kel
Compare kelimination
Measured: 72 hours
Half life
Compare elimination half life
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start10 Nov 2025
- Primary completion28 Dec 2025
- Study completion28 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BioequivalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Full replicate cross-over Bioequivalence study
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zi Diligence Biocenter
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Marcyrl Pharmaceutical Industries
- Responsible party
- Sponsor
- Investigators
- Eman Nouman, PhD, Analytical Chemistry, Study director, Zi Diligence BiocenterAmira Gouda, PhD Analytical Chemistry, Study chair, Zi Diligence BiocenterMostafa Salah, MSc, Pharmacology & Toxicology, Study chair, Zi Diligence BiocenterMohammed Abdulhafez, MBBCH, Principal investigator, Zi Diligence Biocenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495007
- Sponsor's protocol ID
- Pro25085
- Other IDs
- Zi-Pro/Mar-0925-58
- Acronym
- Prontogest
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Might be shared if requested
Publications
Habib YH, Salah M, Galal E, Gouda A, Mosaad Y, Ali M, Mahmoud A, Habib N, Morsi M. Bioequivalence study of Prontogest 100 mg/2 mL solution for intramuscular injection versus reference progesterone injection, USP 500 mg/10 mL under fasting conditions: a randomized, open-label, two-sequence, four-period, fully replicated crossover study in healthy postmenopausal women. Naunyn Schmiedebergs Arch Pharmacol. 2026 Jun 2. doi: 10.1007/s00210-026-05525-0. Online ahead of print.
PubMed 42228061
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07495007
- Acronym / sponsor ID
- Prontogest / Pro25085
- Conditions
- Bioequivalance, Post-menopause
- Keywords
- Bioequivalence, Zi-Diligence, Post-menopause, progesterone injection, baseline correction, Zi Diligence Biocenter
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Zi Diligence BiocenterIndustry (pharma, biotech, devices)
- Collaborators
- Marcyrl Pharmaceutical Industries
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 28 Dec 2025 (actual)
- Study completion
- 28 Dec 2025 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Full replicate cross-over Bioequivalence study
| Arm | Type | Receives |
|---|---|---|
| RTRT | Other | Drug: Progesterone IM of 100 mgsequence of crossover design |
| TRTR | Other | Drug: Progesterone IM of 100 mgsequence of crossover design |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- • 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:
- 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.
Key exclusion criteria (20 listed)
- • Contraindications or hypersensitivity to Progesterone, or any of the formulation excipients or related group of drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progesterone IM of 100 mgAlso: Prontogest ampouleTest Product | Drug | RTRT, TRTR |
| Progesterone IM of 100 mgAlso: Progesterone 100 mg/10mlReference product | Drug | RTRT, TRTR |
Primary outcome
Cmax
Time frame: 72 hours
Determine Bioequivalence for Cmax
AUC0-T
Time frame: 72 hours
Determine Bioequivalence for AUC0-T
3 secondary outcomes
Tmax
Time frame: 72 hours
Kel
Time frame: 72 hours
Half life
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 42228061Habib YH, Salah M, Galal E, Gouda A, Mosaad Y, Ali M, Mahmoud A, Habib N, Morsi M. Bioequivalence study of Prontogest 100 mg/2 mL solution for intramuscular injection versus reference progesterone injection, USP 500 mg/10 mL under fasting conditions: a randomized, open-label, two-sequence, four-period, fully replicated crossover study in healthy postmenopausal women. Naunyn Schmiedebergs Arch Pharmacol. 2026 Jun 2. doi: 10.1007/s00210-026-05525-0. Online ahead of print.
- Individual participant dataSharing planned: No. Might be shared if requested
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman Nouman, PhD, Analytical Chemistry study director
Zi Diligence Biocenter
Amira Gouda, PhD Analytical Chemistry study chair
Zi Diligence Biocenter
Mostafa Salah, MSc, Pharmacology & Toxicology study chair
Zi Diligence Biocenter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Progesterone IM of 100 mg in people with Bioequivalance and Post-menopause, run by Zi Diligence Biocenter at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07495007, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.