Anterior Cruciate Ligament RuptureNCT04986267
The Effects of Hormonal Contraceptives on Incidence of ACL Injury Within Menstrual Cycle Phases
An observational study of Anterior Cruciate Ligament Rupture, run by University of South Australia at 1 site in Australia.
Trial summary
The aim of this study is to investigate how hormonal contraceptives affect ACL rupture incidence within menstrual cycle phases. It is thought hormones such as estrogen and progesterone (which fluctuate throughout the normal menstrual cycle) play a role in the laxity of ligaments within the body. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- ACL Rupture
- How many people
- 98 participants
- Where
- 1 siteAustralia
- Study dates
- 31 May 2021to 31 May 2024
- Phase
- Observational
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Females who present to a sports or orthopaedic clinic with an ACL rupture that occurred within the previous 3 months
Who may be able to join
- Presenting to a sports or orthopaedic clinic with an acute ACL rupture of their knee that occurred within the last 3 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Australia1 site
UniSA Allied Health and Human Performance
Adelaide, South Australia, 5000
About this study
The aim of this study is to investigate how hormonal contraceptives affect ACL rupture incidence within menstrual cycle phases. It is thought hormones such as estrogen and progesterone (which fluctuate throughout the normal menstrual cycle) play a role in the laxity of ligaments within the body. It is hypothesised that around the time of ovulation the ACL undergoes increased laxity, leaving it more likely to be injured. This study will look at the phase of the menstrual cycle in which the ACL injuries occur and whether there are differences due to the use and type of hormonal contraception participants may be using (such as Combined oral contraceptive, Mirena, Implanon), which can modify the levels of circulating estrogen and progesterone.
This study involves participants completing an anonymous electronic survey after presenting to a sports or orthopaedic clinic with an ACL rupture. The survey collects information about participant's current ACL injury and any previous knee injuries; typical menstrual cycle patterns and the use of hormonal contraception; and history of sports participation. Responses will be analysed to look for similarities and differences in ACL injury occurrence by menstrual cycle phase and hormonal contraceptive use.
Read more
The study hypotheses are:
- Hormonal contraceptives that are known to reduce ovulatory rises in estrogen will have the most consistent pattern of ACL rupture incidence across all phases of the menstrual cycle.
- There will be a mitigated risk of ACL rupture in the preovulatory phase of the menstrual cycle, relative to the other phases, in women using hormonal contraception compared to those not using hormonal contraception
- There will be a higher proportion of ACL ruptures during the preovulatory phase of the menstrual cycle in non-hormonal contraceptive users.
Read the detailed description
Anterior Cruciate ligament (ACL) rupture has been observed at higher rates in females than males during sporting competition, particularly during the preovulatory phase of the menstrual cycle. During the menstrual cycle, estrogen secretion varies from 10 to 100 fold throughout the cycle. A possible explanation for the ACL injuries being observed in the preovulatory phase, is that increases in estrogen levels increases the laxity of the ACL, predisposing it to risk of rupture. Studies investigating knee joint laxity, concluded that increased joint laxity was associated with an increased risk of ACL injury. In addition, measurement of knee laxity found no changes in laxity over time in males, but greater anterior displacement of the knee during the preovulatory phase of the menstrual cycle compared with the ovulatory and postovulatory phases in women.
Use of hormonal contraception typically maintains estradiol levels at ~25 pg/ml and decreases the ovulatory rise in estrogen. A study of the use of hormonal contraceptive in alpine skiers with ACL rupture reported that 74% of women were in the preovulatory phase (vs 26% in the postovulatory), experienced an ACL rupture. However, in women with ACL rupture in the preovulatory phase, 72.5% of the women were not using a hormonal contraceptive. A recent systematic review suggested an association between hormonal fluctuations and ACL injury and that hormonal contraceptives offer 20% reduction in risk of injury. Multiple modalities of hormonal and contraceptive control are available to females within Australia, but the efficacy of different hormonal contraceptives for reducing the risk of ACL rupture is unknown.
This study aims to investigate: 1) whether there are differences in risk of an ACL rupture incidence within menstrual cycle phases in females using different types of hormonal contraception. 2) whether there are differences in the pattern of ACL rupture incidence within menstrual cycle phases in females using vs not using hormonal contraception. 3) whether ACL rupture incidence in female athletes not using hormonal contraceptives are more prevalent during the pre-ovulatory phase of the menstrual cycle.
The study will use a cross-sectional design, with data being collected in women presenting at sports medicine or orthopaedic clinics with ACL rupture. On presentation at the clinic with ACL rupture, the study will be introduced to patients by a clinician and they will be shown a recruitment flyer that includes a QR code. On scanning the QR code patients will be taken to a RedCap survey website that they can enter an email in to receive, via automated reply email, a Participant Information Sheet and link to an anonymous study survey. The survey will take approximately 7 minutes to complete and asks questions about how the participants ACL injury occurred, any previous knee injuries, their menstrual cycle phase that the injury occurred in, their usual menstrual cycle characteristics, their use of hormonal contraceptives and the main sport they play.
Injury data will be analyzed according to menstrual cycle phase to confirm whether the preovulatory phase presents higher risk of ACL rupture than the ovulatory/postovulatory phase. Data will be stratified by hormonal contraception use and type to evaluate whether the injury occurrence pattern within the menstrual cycle differs by hormonal contraceptive use, such that the anticipated higher incidence in the preovulatory phase is mitigated with hormonal contraceptive use (and type).
The study hypotheses are:
- Hormonal contraceptives that are known to reduce ovulatory rises in estrogen will have the most consistent pattern of ACL rupture incidence across all phases of the menstrual cycle.
- There will be a mitigated risk of ACL rupture in the preovulatory phase of the menstrual cycle, relative to the other phases, in women using hormonal contraception compared to those not using hormonal contraception
- There will be a higher proportion of ACL ruptures during the preovulatory phase of the menstrual cycle in non-hormonal contraceptive users.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- ACL Rupture
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL RuptureOther
Female, aged 18-40 years of age with an acute ACL rupture of the knee that occurred within the last 3 months, who presented to a sports or orthopaedic clinic
| Study group | Role | What they receive |
|---|---|---|
| ACL Rupture | Female, aged 18-40 years of age with an acute ACL rupture of the knee that occurred within the last 3 months, who presented to a sports or orthopaedic clinic Receives: Other: ACL Rupture |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACL Injury Menstrual Cycle Phase by Hormonal Contraceptive Type
In which phase of the menstrual cycle did the ACL injury occur, by hormonal contraceptive type (including non-use reference)
Measured: Baseline
Secondary outcomes (2)
ACL Injury Menstrual Cycle Phase by Hormonal Contraceptive Use
In which phase of the menstrual cycle did the ACL injury occur, by hormonal contraceptive use vs. non-use
Measured: Baseline
ACL Injury Menstrual Cycle Phase Overall
In which phase of the menstrual cycle did the ACL injury occur (pooled group)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start31 May 2021
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Wycherley, University of South Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986267
- Sponsor's protocol ID
- Buckley_2021
- Status last verified
- Jun 2024
- First submitted
- 6 Jul 2021
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data to be made available on request
Publications
Fox A, Bonacci J, Hoffmann S, Nimphius S, Saunders N. Anterior cruciate ligament injuries in Australian football: should women and girls be playing? You're asking the wrong question. BMJ Open Sport Exerc Med. 2020 Apr 9;6(1):e000778. doi: 10.1136/bmjsem-2020-000778. eCollection 2020.
PubMed 32341803Renstrom P, Ljungqvist A, Arendt E, Beynnon B, Fukubayashi T, Garrett W, Georgoulis T, Hewett TE, Johnson R, Krosshaug T, Mandelbaum B, Micheli L, Myklebust G, Roos E, Roos H, Schamasch P, Shultz S, Werner S, Wojtys E, Engebretsen L. Non-contact ACL injuries in female athletes: an International Olympic Committee current concepts statement. Br J Sports Med. 2008 Jun;42(6):394-412. doi: 10.1136/bjsm.2008.048934.
PubMed 18539658Chidi-Ogbolu N, Baar K. Effect of Estrogen on Musculoskeletal Performance and Injury Risk. Front Physiol. 2019 Jan 15;9:1834. doi: 10.3389/fphys.2018.01834. eCollection 2018.
PubMed 30697162Ramesh R, Von Arx O, Azzopardi T, Schranz PJ. The risk of anterior cruciate ligament rupture with generalised joint laxity. J Bone Joint Surg Br. 2005 Jun;87(6):800-3. doi: 10.1302/0301-620X.87B6.15833.
PubMed 15911662Myer GD, Ford KR, Paterno MV, Nick TG, Hewett TE. The effects of generalized joint laxity on risk of anterior cruciate ligament injury in young female athletes. Am J Sports Med. 2008 Jun;36(6):1073-80. doi: 10.1177/0363546507313572. Epub 2008 Mar 7.
PubMed 18326833Deie M, Sakamaki Y, Sumen Y, Urabe Y, Ikuta Y. Anterior knee laxity in young women varies with their menstrual cycle. Int Orthop. 2002;26(3):154-6. doi: 10.1007/s00264-001-0326-0. Epub 2002 Apr 5.
PubMed 12073107Mishell DR Jr, Thorneycroft IH, Nakamura RM, Nagata Y, Stone SC. Serum estradiol in women ingesting combination oral contraceptive steroids. Am J Obstet Gynecol. 1972 Dec 1;114(7):923-8. doi: 10.1016/0002-9378(72)90098-1.
PubMed 4645131Wojtys EM, Huston LJ, Boynton MD, Spindler KP, Lindenfeld TN. The effect of the menstrual cycle on anterior cruciate ligament injuries in women as determined by hormone levels. Am J Sports Med. 2002 Mar-Apr;30(2):182-8. doi: 10.1177/03635465020300020601.
PubMed 11912085Beynnon BD, Shultz SJ. Anatomic alignment, menstrual cycle phase, and the risk of anterior cruciate ligament injury. J Athl Train. 2008 Sep-Oct;43(5):541-2. doi: 10.4085/1062-6050-43.5.541. No abstract available.
PubMed 18833305Herzberg SD, Motu'apuaka ML, Lambert W, Fu R, Brady J, Guise JM. The Effect of Menstrual Cycle and Contraceptives on ACL Injuries and Laxity: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2017 Jul 21;5(7):2325967117718781. doi: 10.1177/2325967117718781. eCollection 2017 Jul.
PubMed 28795075
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hormonal Contraceptives on Incidence of ACL Injury Within Menstrual Cycle Phases
- ClinicalTrials.gov ID
- NCT04986267
- Acronym / sponsor ID
- Buckley_2021
- Conditions
- Anterior Cruciate Ligament Rupture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of South AustraliaUniversity, hospital or other
- Study start
- 31 May 2021 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 2 Aug 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.
The aim of this study is to investigate how hormonal contraceptives affect ACL rupture incidence within menstrual cycle phases. It is thought hormones such as estrogen and progesterone (which fluctuate throughout the normal menstrual cycle) play a role in the laxity of ligaments within the body. It is hypothesised that around the time of ovulation the ACL undergoes increased laxity, leaving it more likely to be injured. This study will look at the phase of the menstrual cycle in which the ACL injuries occur and whether there are differences due to the use and type of hormonal contraception participants may be using (such as Combined oral contraceptive, Mirena, Implanon), which can modify the levels of circulating estrogen and progesterone.
This study involves participants completing an anonymous electronic survey after presenting to a sports or orthopaedic clinic with an ACL rupture. The survey collects information about participant's current ACL injury and any previous knee injuries; typical menstrual cycle patterns and the use of hormonal contraception; and history of sports participation. Responses will be analysed to look for similarities and differences in ACL injury occurrence by menstrual cycle phase and hormonal contraceptive use.
The study hypotheses are:
- Hormonal contraceptives that are known to reduce ovulatory rises in estrogen will have the most consistent pattern of ACL rupture incidence across all phases of the menstrual cycle.
- There will be a mitigated risk of ACL rupture in the preovulatory phase of the menstrual cycle, relative to the other phases, in women using hormonal contraception compared to those not using hormonal contraception
- There will be a higher proportion of ACL ruptures during the preovulatory phase of the menstrual cycle in non-hormonal contraceptive users.
Detailed description
Anterior Cruciate ligament (ACL) rupture has been observed at higher rates in females than males during sporting competition, particularly during the preovulatory phase of the menstrual cycle. During the menstrual cycle, estrogen secretion varies from 10 to 100 fold throughout the cycle. A possible explanation for the ACL injuries being observed in the preovulatory phase, is that increases in estrogen levels increases the laxity of the ACL, predisposing it to risk of rupture. Studies investigating knee joint laxity, concluded that increased joint laxity was associated with an increased risk of ACL injury. In addition, measurement of knee laxity found no changes in laxity over time in males, but greater anterior displacement of the knee during the preovulatory phase of the menstrual cycle compared with the ovulatory and postovulatory phases in women.
Use of hormonal contraception typically maintains estradiol levels at ~25 pg/ml and decreases the ovulatory rise in estrogen. A study of the use of hormonal contraceptive in alpine skiers with ACL rupture reported that 74% of women were in the preovulatory phase (vs 26% in the postovulatory), experienced an ACL rupture. However, in women with ACL rupture in the preovulatory phase, 72.5% of the women were not using a hormonal contraceptive. A recent systematic review suggested an association between hormonal fluctuations and ACL injury and that hormonal contraceptives offer 20% reduction in risk of injury. Multiple modalities of hormonal and contraceptive control are available to females within Australia, but the efficacy of different hormonal contraceptives for reducing the risk of ACL rupture is unknown.
This study aims to investigate: 1) whether there are differences in risk of an ACL rupture incidence within menstrual cycle phases in females using different types of hormonal contraception. 2) whether there are differences in the pattern of ACL rupture incidence within menstrual cycle phases in females using vs not using hormonal contraception. 3) whether ACL rupture incidence in female athletes not using hormonal contraceptives are more prevalent during the pre-ovulatory phase of the menstrual cycle.
The study will use a cross-sectional design, with data being collected in women presenting at sports medicine or orthopaedic clinics with ACL rupture. On presentation at the clinic with ACL rupture, the study will be introduced to patients by a clinician and they will be shown a recruitment flyer that includes a QR code. On scanning the QR code patients will be taken to a RedCap survey website that they can enter an email in to receive, via automated reply email, a Participant Information Sheet and link to an anonymous study survey. The survey will take approximately 7 minutes to complete and asks questions about how the participants ACL injury occurred, any previous knee injuries, their menstrual cycle phase that the injury occurred in, their usual menstrual cycle characteristics, their use of hormonal contraceptives and the main sport they play.
Injury data will be analyzed according to menstrual cycle phase to confirm whether the preovulatory phase presents higher risk of ACL rupture than the ovulatory/postovulatory phase. Data will be stratified by hormonal contraception use and type to evaluate whether the injury occurrence pattern within the menstrual cycle differs by hormonal contraceptive use, such that the anticipated higher incidence in the preovulatory phase is mitigated with hormonal contraceptive use (and type).
The study hypotheses are:
- Hormonal contraceptives that are known to reduce ovulatory rises in estrogen will have the most consistent pattern of ACL rupture incidence across all phases of the menstrual cycle.
- There will be a mitigated risk of ACL rupture in the preovulatory phase of the menstrual cycle, relative to the other phases, in women using hormonal contraception compared to those not using hormonal contraception
- There will be a higher proportion of ACL ruptures during the preovulatory phase of the menstrual cycle in non-hormonal contraceptive users.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACL Rupture | – | Other: ACL RuptureFemale, aged 18-40 years of age with an acute ACL rupture of the knee that occurred within the last 3 months, who presented to a sports or orthopaedic clinic |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Females who present to a sports or orthopaedic clinic with an ACL rupture that occurred within the previous 3 months
Key inclusion criteria (1 listed)
- Presenting to a sports or orthopaedic clinic with an acute ACL rupture of their knee that occurred within the last 3 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ACL RuptureFemale, aged 18-40 years of age with an acute ACL rupture of the knee that occurred within the last 3 months, who presented to a sports or orthopaedic clinic | Other | ACL Rupture |
Primary outcome
ACL Injury Menstrual Cycle Phase by Hormonal Contraceptive Type
Time frame: Baseline
In which phase of the menstrual cycle did the ACL injury occur, by hormonal contraceptive type (including non-use reference)
2 secondary outcomes
ACL Injury Menstrual Cycle Phase by Hormonal Contraceptive Use
Time frame: Baseline
ACL Injury Menstrual Cycle Phase Overall
Time frame: Baseline
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 18 Jun 2024.
- Background: PubMed 32341803Fox A, Bonacci J, Hoffmann S, Nimphius S, Saunders N. Anterior cruciate ligament injuries in Australian football: should women and girls be playing? You're asking the wrong question. BMJ Open Sport Exerc Med. 2020 Apr 9;6(1):e000778. doi: 10.1136/bmjsem-2020-000778. eCollection 2020.
- Background: PubMed 18539658Renstrom P, Ljungqvist A, Arendt E, Beynnon B, Fukubayashi T, Garrett W, Georgoulis T, Hewett TE, Johnson R, Krosshaug T, Mandelbaum B, Micheli L, Myklebust G, Roos E, Roos H, Schamasch P, Shultz S, Werner S, Wojtys E, Engebretsen L. Non-contact ACL injuries in female athletes: an International Olympic Committee current concepts statement. Br J Sports Med. 2008 Jun;42(6):394-412. doi: 10.1136/bjsm.2008.048934.
- Background: PubMed 30697162Chidi-Ogbolu N, Baar K. Effect of Estrogen on Musculoskeletal Performance and Injury Risk. Front Physiol. 2019 Jan 15;9:1834. doi: 10.3389/fphys.2018.01834. eCollection 2018.
- Background: PubMed 15911662Ramesh R, Von Arx O, Azzopardi T, Schranz PJ. The risk of anterior cruciate ligament rupture with generalised joint laxity. J Bone Joint Surg Br. 2005 Jun;87(6):800-3. doi: 10.1302/0301-620X.87B6.15833.
- Background: PubMed 18326833Myer GD, Ford KR, Paterno MV, Nick TG, Hewett TE. The effects of generalized joint laxity on risk of anterior cruciate ligament injury in young female athletes. Am J Sports Med. 2008 Jun;36(6):1073-80. doi: 10.1177/0363546507313572. Epub 2008 Mar 7.
- Background: PubMed 12073107Deie M, Sakamaki Y, Sumen Y, Urabe Y, Ikuta Y. Anterior knee laxity in young women varies with their menstrual cycle. Int Orthop. 2002;26(3):154-6. doi: 10.1007/s00264-001-0326-0. Epub 2002 Apr 5.
- Background: PubMed 4645131Mishell DR Jr, Thorneycroft IH, Nakamura RM, Nagata Y, Stone SC. Serum estradiol in women ingesting combination oral contraceptive steroids. Am J Obstet Gynecol. 1972 Dec 1;114(7):923-8. doi: 10.1016/0002-9378(72)90098-1.
- Background: PubMed 11912085Wojtys EM, Huston LJ, Boynton MD, Spindler KP, Lindenfeld TN. The effect of the menstrual cycle on anterior cruciate ligament injuries in women as determined by hormone levels. Am J Sports Med. 2002 Mar-Apr;30(2):182-8. doi: 10.1177/03635465020300020601.
- Background: PubMed 18833305Beynnon BD, Shultz SJ. Anatomic alignment, menstrual cycle phase, and the risk of anterior cruciate ligament injury. J Athl Train. 2008 Sep-Oct;43(5):541-2. doi: 10.4085/1062-6050-43.5.541. No abstract available.
- Background: PubMed 28795075Herzberg SD, Motu'apuaka ML, Lambert W, Fu R, Brady J, Guise JM. The Effect of Menstrual Cycle and Contraceptives on ACL Injuries and Laxity: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2017 Jul 21;5(7):2325967117718781. doi: 10.1177/2325967117718781. eCollection 2017 Jul.
- Individual participant dataSharing planned: Undecided. Data to be made available on request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Rupture, run by University of South Australia at 1 site in Australia.
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 1 inclusion and 0 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 18 Jun 2024. 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 Australia. 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?
ACL Injury Menstrual Cycle Phase by Hormonal Contraceptive Type (time frame: Baseline). 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 NCT04986267, which also lists 10 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 18 Jun 2024.