Post MenopauseHIRTNCT05052749
High Intensity Resistance Training In Postmenopausal Women (HIRT)
A study testing High Intensity Resistance Training (HIRT) and Low-moderate Resistance Exercise Training in people with Post Menopause, run by Riphah International University at 1 site in Pakistan.
Trial summary
Menopause is defined as a permanent cessation of menstrual cycle for 12 months due to intrinsic diminution of ovarian oocytes among women in older age. Globally reported mean age for menopause is 48.78 years (ranges from 46-52 years). Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Menopause
- What is being tested?
- High Intensity Resistance Training (HIRT) and Low-moderate Resistance Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2021to 31 Dec 2021
- Phase
- Interventional
- 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 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women
- Age: 45-70 years
- Sedentary life style
Who cannot join
- High risk of fracture as calculated by WHO online FRAX tool.
- Presence/history of fragility fracture.
- MMSE < 20
- Systemic illness: hyperthyroidism, hyperparathyroidism, renal failure, any malignancy, extensive radiation exposure.
- Any orthopedic injury/disorder hindering performance of exercise.
- Not willing for exercise.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah Rehabilitation Center, RCRAHS Westridge campus
Rawalpindi, Punjab Province, 44000
About this study
Official title: Effects of High Intensity Resistance Training in Postmenopausal Women
Menopause is defined as a permanent cessation of menstrual cycle for 12 months due to intrinsic diminution of ovarian oocytes among women in older age. Globally reported mean age for menopause is 48.78 years (ranges from 46-52 years). Menopausal age reported among Asian and African population was lower as compared to European women . Among postmenopausal women, age related various central nervous system, musculoskeletal, urogenital, metabolic and skin changes ensue along with osteoporosis (T-score = ≤ -2.5) and decreased bone mineral density due to estrogen deficiency that is directly associated with fragility fractures and disability among this age group. Therefore, recruitment of older adults in resistance training program is crucial in inducing increases in muscle strength and ameliorating glucose tolerance and increased insulin sensitivity along with improvements in BMD and BMR.
Read the detailed description
Physical activity is extremely crucial in maintaining quality of life and estrogen metabolism among postmenopausal women, owing to the increased risk of falls, age related decline in cardiopulmonary, musculoskeletal endurance and cognitive capacity. In Pakistan, fitness of women specifically of postmenopausal age group is ignored due to some cultural norms. Performance of physical activity in the form of resistance training (RT) is one of the best known methods to improve physical fitness in the elderly. So the current study is planned with objectives to determine effects of High Intensity Resistance Training in Postmenopausal Women. Supervised exercise training will be provided for 3 months and functional performance will be measured accordingly.
After initial screening of postmenopausal women including history and anthropometric details, females meeting inclusion criteria and willing to participate in high intensity resistance exercise trial will be recruited in the study. After that; physical fitness, performance base testing for functional performance outcome measures and MENQOL assessment will be done at baseline and after 3 months. Patients will perform resistance training twice a week, 40-50 min/session for 12 weeks respectively. It is hypothesized that supervised high intensity resistance training will improve functional performance, physical fitness and Quality of life among postmenopausal women.
- Conditions
- Post Menopause
- Being tested
- High Intensity Resistance Training (HIRT), Low-moderate Resistance Exercise Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Resistance Training (HIRT)Other
High Intensity Resistance Exercises Supervised High Intensity Resistance Training with 15 minutes of cycling as a warm-up activity then HIRT through Quadriceps drill, Squats, Lunges, Leg press, Biceps curls and Deadlift with 120 seconds of rest interval between each set of exercise and between exercises will be performed by the participants with appropriate cool down through generalized stretching exercises. Participants will perform exercises twice weekly, 40-50 minutes/session for 12 weeks respectively.
Low-moderate Resistance Exercise TrainingOther
Supervised Low-moderate Resistance Training with 15 minutes of cycling as a warm-up activity then Quadriceps drill, Squats, Lunges, Leg press, Biceps curls and Deadlift with 120 seconds of rest interval between each set of exercise and between exercises will be performed by the participants with appropriate cool down through generalized stretching exercises. Participants will perform exercises twice weekly, 40-50 minutes/session for 12 weeks respectively.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Resistance Training (HIRT) | Experimental | In this HIRT group, participants will perform warm-up activity for 15 minutes then high intensity resistance exercises with 120 seconds of rest interval between each set of exercise and between exercises respectively. After that, generalized stretching exercises as a cool down activity will be performed by the participants. Participants will perform exercises twice weekly, 40-50 minutes/session for 12 weeks under supervision. Receives: Other: High Intensity Resistance Training (HIRT) |
| Low-moderate Resistance Exercise Training | Active comparator | In this low-moderate resistance training group, participants will perform warm-up activity for 15 minutes then low-moderate intensity resistance exercises with 120 seconds of rest interval between each set of exercise and between exercises respectively. After that, generalized stretching exercises as a cool down activity will be performed by the participants. Participants will perform exercises twice weekly, 40-50 minutes/session for 12 weeks under supervision. Receives: Other: Low-moderate Resistance Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
10RM leg press
Assessed from baseline. 10 RM is used to assess maximum muscle strength that is to extend knee 10 times against maximum resistance. Weight will be recorded in Kgs.
[Time Frame: 3 Months]
Measured: 3 months
10RM dead lift (kg)
Assessed from baseline. 10 RM is used to assess maximum muscle strength that is to lift weight 10 times against maximum resistance. Weight will be recorded in Kgs.
Measured: 3 months
Sit and reach test (cm)
Assessed from baseline. It is linear flexibility test used to measure extensibility of hamstrings and lower back. Participant will perform test in seated position with extended knees, distance between extended fingers and top of the toe will be recorded in cm.
Measured: 3 months
Sit and stand test (reps)
Assessed from baseline. In this test participant will rise to full standing position from seated position without using armrests of chair and researcher will count the number of complete stand from sitting position within 30 seconds. Inaccurately accomplished stands will not be counted.
Measured: 3 months
Plank test (sec)
Assessed from baseline. It is fitness test that measures the endurance of core stabilizing muscles. Participants will be in prone position with elbow flexion at 90° and forearm resting on floor and toes touching the floor. Two trials will be recorded with 1.5 minutes of rest interval between attempts and extensive isometric time will be used for analysis.
Measured: 3 months
6 - minutes' walk test (sec)
Assessed from baseline. It is sub-maximal exercise test used to evaluate aerobic capacity and endurance. Participant will walk in 30-metre walkway with marked ends for 6 minutes. Patient will be permitted to slow down, stop or rest when required. Record the distance walked in 6 minutes' duration with vital signs monitoring.
Measured: 3 months
Gait speed
Assessed from baseline. Gait speed test is used to assess functional mobility of an individual. Gait speed will be measured from 6-m distance in 10-m track using stopwatch with 2 meters for acceleration and 2 meters for deceleration respectively. Two trials will be performed and then average score will be taken for analysis. Participant will start walking with dominant foot with maximum pace possible.
Measured: 3 months
Menopause specific Quality of life (MENQOL)
Assessed from baseline. Menopause specific Quality of life is the tool used to assess quality of life among postmenopausal women in the past month. It has four domains of menopausal symptoms; vasomotor, psychosocial, physical and sexual. A total of 29 items in a 6 point Likert-scale is used, with 0 means not at all bothered and 6 means extremely bothered. the minimum score is 0 and maximum is 174.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Mar 2021
- Primary completion15 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post MenopauseStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a single factor, Pretest-Posttest Control Group Design with parallel assignment of patients in to two groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huma Riaz, PHD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052749
- Sponsor's protocol ID
- REC/00915 Qurat-ul-Ain
- Acronym
- HIRT
- Status last verified
- Feb 2022
- First submitted
- 13 Sep 2021
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu D, Chung HF, Dobson AJ, Pandeya N, Giles GG, Bruinsma F, Brunner EJ, Kuh D, Hardy R, Avis NE, Gold EB, Derby CA, Matthews KA, Cade JE, Greenwood DC, Demakakos P, Brown DE, Sievert LL, Anderson D, Hayashi K, Lee JS, Mizunuma H, Tillin T, Simonsen MK, Adami HO, Weiderpass E, Mishra GD. Age at natural menopause and risk of incident cardiovascular disease: a pooled analysis of individual patient data. Lancet Public Health. 2019 Nov;4(11):e553-e564. doi: 10.1016/S2468-2667(19)30155-0. Epub 2019 Oct 3.
PubMed 31588031Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause - global prevalence, physiology and implications. Nat Rev Endocrinol. 2018 Apr;14(4):199-215. doi: 10.1038/nrendo.2017.180. Epub 2018 Feb 2.
PubMed 29393299Maillard F, Rousset S, Pereira B, Traore A, de Pradel Del Amaze P, Boirie Y, Duclos M, Boisseau N. High-intensity interval training reduces abdominal fat mass in postmenopausal women with type 2 diabetes. Diabetes Metab. 2016 Dec;42(6):433-441. doi: 10.1016/j.diabet.2016.07.031. Epub 2016 Aug 24.
PubMed 27567125Daly RM, Dalla Via J, Duckham RL, Fraser SF, Helge EW. Exercise for the prevention of osteoporosis in postmenopausal women: an evidence-based guide to the optimal prescription. Braz J Phys Ther. 2019 Mar-Apr;23(2):170-180. doi: 10.1016/j.bjpt.2018.11.011. Epub 2018 Nov 22.
PubMed 30503353Socha M, Fraczak P, Jonak W, Sobiech KA. Effect of resistance training with elements of stretching on body composition and quality of life in postmenopausal women. Prz Menopauzalny. 2016 Mar;15(1):26-31. doi: 10.5114/pm.2016.58770. Epub 2016 Mar 29.
PubMed 27095955Dias RKN, Penna EM, Noronha ASN, de Azevedo ABC, Barbalho M, Gentil PV, Coswig VS. Cluster-sets resistance training induce similar functional and strength improvements than the traditional method in postmenopausal and elderly women. Exp Gerontol. 2020 Sep;138:111011. doi: 10.1016/j.exger.2020.111011. Epub 2020 Jun 24.
PubMed 32592830
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intensity Resistance Training in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05052749
- Acronym / sponsor ID
- HIRT / REC/00915 Qurat-ul-Ain
- Conditions
- Post Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 22 Sep 2021 (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.
Menopause is defined as a permanent cessation of menstrual cycle for 12 months due to intrinsic diminution of ovarian oocytes among women in older age. Globally reported mean age for menopause is 48.78 years (ranges from 46-52 years). Menopausal age reported among Asian and African population was lower as compared to European women . Among postmenopausal women, age related various central nervous system, musculoskeletal, urogenital, metabolic and skin changes ensue along with osteoporosis (T-score = ≤ -2.5) and decreased bone mineral density due to estrogen deficiency that is directly associated with fragility fractures and disability among this age group. Therefore, recruitment of older adults in resistance training program is crucial in inducing increases in muscle strength and ameliorating glucose tolerance and increased insulin sensitivity along with improvements in BMD and BMR.
Detailed description
Physical activity is extremely crucial in maintaining quality of life and estrogen metabolism among postmenopausal women, owing to the increased risk of falls, age related decline in cardiopulmonary, musculoskeletal endurance and cognitive capacity. In Pakistan, fitness of women specifically of postmenopausal age group is ignored due to some cultural norms. Performance of physical activity in the form of resistance training (RT) is one of the best known methods to improve physical fitness in the elderly. So the current study is planned with objectives to determine effects of High Intensity Resistance Training in Postmenopausal Women. Supervised exercise training will be provided for 3 months and functional performance will be measured accordingly.
After initial screening of postmenopausal women including history and anthropometric details, females meeting inclusion criteria and willing to participate in high intensity resistance exercise trial will be recruited in the study. After that; physical fitness, performance base testing for functional performance outcome measures and MENQOL assessment will be done at baseline and after 3 months. Patients will perform resistance training twice a week, 40-50 min/session for 12 weeks respectively. It is hypothesized that supervised high intensity resistance training will improve functional performance, physical fitness and Quality of life among postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This will be a single factor, Pretest-Posttest Control Group Design with parallel assignment of patients in to two groups.
| Arm | Type | Receives |
|---|---|---|
| High Intensity Resistance Training (HIRT) | Experimental | Other: High Intensity Resistance Training (HIRT)In this HIRT group, participants will perform warm-up activity for 15 minutes then high intensity resistance exercises with 120 seconds of rest interval between each set of exercise and between exercises respectively. After that, generalized stretching exercises as a cool down activity will be performed by the participants. Participants will perform exercises twice weekly, 40-50 minutes/session for 12 weeks under supervision. |
| Low-moderate Resistance Exercise Training | Active comparator | Other: Low-moderate Resistance Exercise TrainingIn this low-moderate resistance training group, participants will perform warm-up activity for 15 minutes then low-moderate intensity resistance exercises with 120 seconds of rest interval between each set of exercise and between exercises respectively. After that, generalized stretching exercises as a cool down activity will be performed by the participants. Participants will perform exercises twice weekly, 40-50 minutes/session for 12 weeks under supervision. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal women
- Age: 45-70 years
- Sedentary life style
Key exclusion criteria (6 listed)
- High risk of fracture as calculated by WHO online FRAX tool.
- Presence/history of fragility fracture.
- MMSE < 20
- Systemic illness: hyperthyroidism, hyperparathyroidism, renal failure, any malignancy, extensive radiation exposure.
- Any orthopedic injury/disorder hindering performance of exercise.
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 |
|---|---|---|
| High Intensity Resistance Training (HIRT)High Intensity Resistance Exercises Supervised High Intensity Resistance Training with 15 minutes of cycling as a warm-up activity then HIRT through Quadriceps drill, Squats, Lunges, Leg press, Biceps curls and Deadlift with 120 seconds of rest interval between each set of exercise and between exercises will be performed by the participants with appropriate cool down through generalized stretching exercises. Participants will perform exercises twice weekly, 40-50 minutes/session for 12 weeks respectively. | Other | High Intensity Resistance Training (HIRT) |
| Low-moderate Resistance Exercise TrainingSupervised Low-moderate Resistance Training with 15 minutes of cycling as a warm-up activity then Quadriceps drill, Squats, Lunges, Leg press, Biceps curls and Deadlift with 120 seconds of rest interval between each set of exercise and between exercises will be performed by the participants with appropriate cool down through generalized stretching exercises. Participants will perform exercises twice weekly, 40-50 minutes/session for 12 weeks respectively. | Other | Low-moderate Resistance Exercise Training |
Primary outcome
10RM leg press
Time frame: 3 months
Assessed from baseline. 10 RM is used to assess maximum muscle strength that is to extend knee 10 times against maximum resistance. Weight will be recorded in Kgs. [Time Frame: 3 Months]
10RM dead lift (kg)
Time frame: 3 months
Assessed from baseline. 10 RM is used to assess maximum muscle strength that is to lift weight 10 times against maximum resistance. Weight will be recorded in Kgs.
Sit and reach test (cm)
Time frame: 3 months
Assessed from baseline. It is linear flexibility test used to measure extensibility of hamstrings and lower back. Participant will perform test in seated position with extended knees, distance between extended fingers and top of the toe will be recorded in cm.
Sit and stand test (reps)
Time frame: 3 months
Assessed from baseline. In this test participant will rise to full standing position from seated position without using armrests of chair and researcher will count the number of complete stand from sitting position within 30 seconds. Inaccurately accomplished stands will not be counted.
Plank test (sec)
Time frame: 3 months
Assessed from baseline. It is fitness test that measures the endurance of core stabilizing muscles. Participants will be in prone position with elbow flexion at 90° and forearm resting on floor and toes touching the floor. Two trials will be recorded with 1.5 minutes of rest interval between attempts and extensive isometric time will be used for analysis.
6 - minutes' walk test (sec)
Time frame: 3 months
Assessed from baseline. It is sub-maximal exercise test used to evaluate aerobic capacity and endurance. Participant will walk in 30-metre walkway with marked ends for 6 minutes. Patient will be permitted to slow down, stop or rest when required. Record the distance walked in 6 minutes' duration with vital signs monitoring.
Gait speed
Time frame: 3 months
Assessed from baseline. Gait speed test is used to assess functional mobility of an individual. Gait speed will be measured from 6-m distance in 10-m track using stopwatch with 2 meters for acceleration and 2 meters for deceleration respectively. Two trials will be performed and then average score will be taken for analysis. Participant will start walking with dominant foot with maximum pace possible.
Menopause specific Quality of life (MENQOL)
Time frame: 3 months
Assessed from baseline. Menopause specific Quality of life is the tool used to assess quality of life among postmenopausal women in the past month. It has four domains of menopausal symptoms; vasomotor, psychosocial, physical and sexual. A total of 29 items in a 6 point Likert-scale is used, with 0 means not at all bothered and 6 means extremely bothered. the minimum score is 0 and maximum is 174.
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 2 Feb 2022.
- Background: PubMed 31588031Zhu D, Chung HF, Dobson AJ, Pandeya N, Giles GG, Bruinsma F, Brunner EJ, Kuh D, Hardy R, Avis NE, Gold EB, Derby CA, Matthews KA, Cade JE, Greenwood DC, Demakakos P, Brown DE, Sievert LL, Anderson D, Hayashi K, Lee JS, Mizunuma H, Tillin T, Simonsen MK, Adami HO, Weiderpass E, Mishra GD. Age at natural menopause and risk of incident cardiovascular disease: a pooled analysis of individual patient data. Lancet Public Health. 2019 Nov;4(11):e553-e564. doi: 10.1016/S2468-2667(19)30155-0. Epub 2019 Oct 3.
- Background: PubMed 29393299Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause - global prevalence, physiology and implications. Nat Rev Endocrinol. 2018 Apr;14(4):199-215. doi: 10.1038/nrendo.2017.180. Epub 2018 Feb 2.
- Background: PubMed 27567125Maillard F, Rousset S, Pereira B, Traore A, de Pradel Del Amaze P, Boirie Y, Duclos M, Boisseau N. High-intensity interval training reduces abdominal fat mass in postmenopausal women with type 2 diabetes. Diabetes Metab. 2016 Dec;42(6):433-441. doi: 10.1016/j.diabet.2016.07.031. Epub 2016 Aug 24.
- Background: PubMed 30503353Daly RM, Dalla Via J, Duckham RL, Fraser SF, Helge EW. Exercise for the prevention of osteoporosis in postmenopausal women: an evidence-based guide to the optimal prescription. Braz J Phys Ther. 2019 Mar-Apr;23(2):170-180. doi: 10.1016/j.bjpt.2018.11.011. Epub 2018 Nov 22.
- Background: PubMed 27095955Socha M, Fraczak P, Jonak W, Sobiech KA. Effect of resistance training with elements of stretching on body composition and quality of life in postmenopausal women. Prz Menopauzalny. 2016 Mar;15(1):26-31. doi: 10.5114/pm.2016.58770. Epub 2016 Mar 29.
- Background: PubMed 32592830Dias RKN, Penna EM, Noronha ASN, de Azevedo ABC, Barbalho M, Gentil PV, Coswig VS. Cluster-sets resistance training induce similar functional and strength improvements than the traditional method in postmenopausal and elderly women. Exp Gerontol. 2020 Sep;138:111011. doi: 10.1016/j.exger.2020.111011. Epub 2020 Jun 24.
- Individual participant dataSharing planned: No
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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.
Huma Riaz, PHD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Resistance Training (HIRT) and Low-moderate Resistance Exercise Training in people with Post Menopause, run by Riphah International University at 1 site in Pakistan.
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 3 inclusion and 6 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 2 Feb 2022. 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 Pakistan. 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.
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?
10RM leg press (time frame: 3 months). The study lists 8 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 NCT05052749, which also lists 6 linked publications.
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 2 Feb 2022.