StrokePhase 4NCT04143880

Progesterone in the Treatment of Acute Hemorrhagic Stroke

A Phase 4 study testing Progesterone and saline in people with Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Stroke
What is being tested?: Progesterone and saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 184 participants
Where: No sites listed yet
Study dates: 1 Feb 2020to 31 Dec 2020
Phase: Phase 4
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Acute hemorrhagic stroke was confirmed by CT or MRI. There should be no obvious sequelae symptoms in the first stroke or previous stroke, Mrs < 2 (slight or no neurological dysfunction).
Patients aged 40-80 (male, menopausal women);
Patients with 6-48 hours of onset;
3 points ≤ NIHSS score ≤ 15 points for light and medium patients;
Patients or family members sign informed consent.

Who cannot join

Cerebral CT has excluded intracranial hemorrhage, and there is no imaging change of early large area cerebral infarction.
Pregnant or lactating women;
Previous intracranial hemorrhage, including suspected subarachnoid hemorrhage; large area stroke (> 2 / 3 MCA territory) or head CT showed any degree of midline displacement due to brain edema. Signs of intracranial hemorrhage (ICH, SAH, extradural hemorrhage, acute or chronic SDH) were found on baseline CT or MRI scan.
Fever, defined as central body temperature > 37.5 ℃;
Patients with severe heart, liver and kidney dysfunction or severe diabetes;
Platelet count was less than 100 × 109 / L, blood glucose was less than 27 mmol / L, serum creatinine was more than 2.0 mg / dL or 180 μ mol / L.

Show all 11Show fewer

Blood pressure: systolic pressure > 180 mmHg, or diastolic pressure > 100 mmHg;
Those who have previous allergic history to progesterone and citicoline;
The anticoagulant has been taken orally, and INR is more than 15; heparin has been taken within 48 hours (APTT is beyond the normal range);
Participating in clinical trials of any other treatment;
Patients considered by the researchers not suitable for inclusion.

About this study

Official title: An International Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Progesterone Combined Intranasal and Intramuscular Administration in Patients With Acute Hemorrhagic Stroke

A large number of preclinical studies have confirmed that progesterone and its metabolites have strong neuroprotective effects. As a neuroprotective agent, progesterone has been effective in several animal models of nerve injury, suggesting that the drug has a wide range of neuroprotective effects. Pharmacodynamic studies have shown that some characteristic mechanisms of the action of the neurosteroid on brain injury and cerebral congestion include: prevention of inflammatory reaction and cell death (by inhibiting the activation of inflammatory cytokines and microglia); control of angiogenic brain edema (by reestablishing blood-brain barrier and regulating aquaporin-4 water transporter) and cytotoxic edema (by regulating Progesterone can also improve the neural dysfunction after cerebral hemorrhage, promote the regeneration and repair of damaged axons (activate PI3K / Akt pathway to inhibit the expression of RhoA), prevent the loss of Ca2 + caused by excitotoxicity and improve the survival rate of neurons. It was found that progesterone injection could reduce brain edema and promote the recovery of nerve function after brain injury.

Read the detailed description

The purpose of this clinical trial is to further evaluate the safety and effectiveness of progesterone in the clinical application of major cerebral congestion diseases. The Second Affiliated Hospital of Zhejiang University is the unit in charge of clinical research, and six units participate in the multicenter randomized, double-blind, placebo-controlled clinical trial.

Conditions: Stroke
Being tested: Progesterone, saline
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ProgesteroneDrug
Also called progesterone injection
intramuscular injection intranasal administration
salineOther
intramuscular injection intranasal administration

Study groups in NCT04143880
Study group	Role	What they receive
experimental group	Experimental	Progesterone Receives: Drug: Progesterone
control grou	Placebo comparator	saline Receives: Other: saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Modified Rankin Scale
The percentage of patients with Mrs score 0, 1 and 2 was compared.
Measured: 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202031 Dec 2020

First posted29 Oct 2019
Study start1 Feb 2020 (estimated)
Primary completion31 Oct 2020 (estimated)
Study completion31 Dec 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for StrokeStudies of the same condition, open and under way.
More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 184 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04143880
Sponsor's protocol ID: YANWQ001
Status last verified: Oct 2019
First submitted: 15 Oct 2019
Last updated: 27 Nov 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An International Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Progesterone Combined Intranasal and Intramuscular Administration in Patients With Acute Hemorrhagic Stroke
ClinicalTrials.gov ID: NCT04143880
Acronym / sponsor ID: YANWQ001
Conditions: Stroke
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 184 participants (estimated)
Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
Collaborators: Korea University Anam Hospital, Seoul National University Hospital, Lishui Country People's Hospital, Jinhua Central Hospital, Huzhou Central Hospital, The Affiliated Hospital of Hangzhou Normal University
Study start: 1 Feb 2020 (estimated)
Primary completion: 31 Oct 2020 (estimated)
Study completion: 31 Dec 2020 (estimated)
First posted: 29 Oct 2019 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
experimental group	Experimental	Drug: ProgesteroneProgesterone
control grou	Placebo comparator	Other: salinesaline

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Acute hemorrhagic stroke was confirmed by CT or MRI. There should be no obvious sequelae symptoms in the first stroke or previous stroke, Mrs < 2 (slight or no neurological dysfunction).
Patients aged 40-80 (male, menopausal women);
Patients with 6-48 hours of onset;
3 points ≤ NIHSS score ≤ 15 points for light and medium patients;
Patients or family members sign informed consent.

Key exclusion criteria (11 listed)

Cerebral CT has excluded intracranial hemorrhage, and there is no imaging change of early large area cerebral infarction.
Pregnant or lactating women;
Previous intracranial hemorrhage, including suspected subarachnoid hemorrhage; large area stroke (> 2 / 3 MCA territory) or head CT showed any degree of midline displacement due to brain edema. Signs of intracranial hemorrhage (ICH, SAH, extradural hemorrhage, acute or chronic SDH) were found on baseline CT or MRI scan.
Fever, defined as central body temperature > 37.5 ℃;
Patients with severe heart, liver and kidney dysfunction or severe diabetes;

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
ProgesteroneAlso: progesterone injectionintramuscular injection intranasal administration	Drug	experimental group
salineintramuscular injection intranasal administration	Other	control grou

Primary outcome

Modified Rankin Scale
Time frame: 3 month
The percentage of patients with Mrs score 0, 1 and 2 was compared.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Progesterone and saline in people with Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.

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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Modified Rankin Scale (time frame: 3 month). 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 NCT04143880.

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 Nov 2019; AzTrials last refreshed its copy on 8 Nov 2026.