Menopausal SymptomsPhase 3NCT05586724
Micronized Progesterone Versus Norethisterone Acetate in Combination With Estrogen as Menopausal Hormone Therapy
A Phase 3 study testing Micronized progesterone in continuous combination with oral estrogen and Norethisterone acetate in continuous combination with oral estrogen in people with Menopausal Symptoms, run by Angelica Lindén Hirschberg at 1 site in Sweden.
Trial summary
About one third of all women during menopausal transition have significant climacteric symptoms with considerable impact on quality of life. Meta-analysis has shown a beneficial risk profile with menopausal hormone therapy (MHT) for women 50 to 60 years. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Menopausal Symptoms
- What is being tested?
- Micronized progesterone in continuous combination with oral estrogen and Norethisterone acetate in continuous combination with oral estrogen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteSweden
- Study dates
- 15 Mar 2022to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy and naturally postmenopausal women (more than one year since last menstruation or FSH > 40 IE/L) with climacteric symptoms (sweating, hot flush and/or sleep problems) that adversely affect the quality of life
- Age 45-60 years
- BMI > 19 kg/m2 and ≤ 32 kg/m2
- Intact uterus
- In case of previous MHT use, washout 8 weeks for oral MHT and 4 weeks for transdermal MHT or local estrogen treatment before screening
- Written informed consent
Who cannot join
- Previous history or risk factors for breast cancer, breast cancer in situ or abnormal mammogram at baseline as assessed clinically by a radiology expert
- Previous history or risk factors for endometrial cancer or hyperplasia or abnormal/proliferative endometrial biopsy at baseline
- Vaginal bleeding
- Any concomitant medical treatment except for well-controlled hypertension, non-insulin treated type 2 diabetes, asthma and hypothyroidism
- History or presence of or risk factor for cardiovascular disease including thromboembolic disorder or cerebrovascular disease
- History or presence of liver and gallbladder disease, familial hyperlipidemia, epilepsy or classical migraine with aura
Show all 12Show fewer
- History or presence of clinically significant depression or other psychiatric disorder that might in anyway compromise the performance of the trial or undermine its scientific validity
- Porphyria, Systemic lupus erythematosus and otosclerosis
- Current use of MHT or local estrogen treatment
- Alcohol and/or drug abuse
- Clinically significant findings on physical and/or gynecological examination at baseline
- Hypersensitivity to any of the study treatments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 171 76
Angelica L Hirschberg, +46702559924, angelica.linden-hirschberg@regionstockholm.se
Helena Kopp Kallner, MD, PhD
About this study
Official title: Safety of Oral Micronized Progesterone Versus Norethisterone Acetate in Continuous Combination With Oral Estrogen as Menopausal Hormone Therapy - a Double-blind Randomized Study- PROBES Study (Progesterone Breast Endometrial Safety Study)
About one third of all women during menopausal transition have significant climacteric symptoms with considerable impact on quality of life. Meta-analysis has shown a beneficial risk profile with menopausal hormone therapy (MHT) for women 50 to 60 years. Still, there is a great need to find safe MHT able to control excessive endometrial stimulation by estrogen without stimulatory effects on the breast by the combination of estrogen/progestogen. Recent observational studies indicate a lower risk for breast cancer using micronized progesterone (mP) combined with estrogen but increased risk of endometrial cancer than by standard MHT. In a randomized trial, the balance between benefits and risks of mP vs. progestogens (norethisterone (NETA)) in combination with estrogen will be explored. For apparent reasons, long-term largescale clinical trials with endometrial and breast cancer as the primary endpoints, are not feasible. However, much knowledge can be obtained using relevant surrogate markers. Mammographic breast density is a strong risk factor for breast cancer, and endometrial hyperplasia is a strong risk factor for endometrial cancer. The primary objective is to compare the effects of one year treatment with mP versus progestogen, in combination with estradiol on mammographic breast density. Furthermore, to evaluate the effect of one year treatment with mP in continuous combination with estradiol on endometrial pathology (hyperplasia and cancer).
Read the detailed description
Postmenopausal women with climacteric symptoms will be randomized (1:1) to double blind treatment with oral mP or NETA in combination with oral estradiol. For the breast part, a power analysis revealed that 91 women/group would be sufficient to detect a significant difference in mammographic breast density between the groups at the 5%-level (two-sided) with 80% power. Considering the estimated rate of discontinuation and incomplete data, the target sample for the breast part is 260 patients. For the endometrial part, it is estimated that two or less women with serious adverse endometrial outcomes would result in an annual incidence of endometrial pathology of 0.67% or less with an upper bound of the one-sided 95% CI of 2.08% or less. Considering the estimated rate of discontinuation and incomplete data in the mP + estradiol group, the target sample for this part of the study is 390 patients. The total number of patients in part 1 and 2 will be 520.
Mammography at baseline and after 12 months of treatment will be assessed by independent radiologists at the Karolinska University Hospital blinded to treatment. In addition to visual judgment, a computer based quantitative assessment will be performed. All mammograms will be anonymous so that the operator will be unaware of the patient's identity and type of treatment. Percentage change in mammographic density will be evaluated and compared between the groups.
Endometrial biopsies at baseline and after 12 months of treatment will be evaluated by two independent pathologists at the Karolinska University Hospital for the incidence of endometrial pathology (hyperplasia or cancer) in the mP + estradiol group. Furthermore, immunostaining of the proliferation marker Ki-67, and other markers related to proliferation and apoptosis will be analyzed and compared between groups.
Different validated self-assessment questionnaires will be used for screening of mood disorders like depression and anxiety, as well as quality of life and menopausal symptoms. The Patient Health Questionnaire (PHQ-9) is a tool for screening, diagnosing, and measuring the severity of depression. The Hospital Anxiety and Depression Scale (HADS) is an instrument for detecting states of depression and anxiety in the setting of a hospital or medical outpatient clinic. Health related quality of life is measured using the Psychological General Well-Being Index (PGWB). The Women's Health Questionnaire (WHQ) measures menopausal symptoms. The change in scores will be compared between the groups.
Blood lipid profile, serum hormones, growth and metabolic factors, and coagulation factors will be analyzed.
The gut- and vaginal microbiome will be characterized and compared between groups.
- Conditions
- Menopausal Symptoms
- Being tested
- Micronized progesterone in continuous combination with oral estrogen, Norethisterone acetate in continuous combination with oral estrogen
- Keywords
- Menopausal hormone therapy, Climacteric symptoms, Progesterone, Progestogens, Breast safety, Endometrial safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronized progesterone in continuous combination with oral estrogenDrug
Capsule 100 mg mP (Utrogestan®) orally per day in continuous combination with 1 mg encapsulated estradiol (Estrofem®)
Norethisterone acetate in continuous combination with oral estrogenDrug
Capsule 0.5 mg NETA/ 1 mg estradiol (Activelle®) orally per day (encapsulated and identical to Estrofem® and one matched placebo to Utrogestan
| Study group | Role | What they receive |
|---|---|---|
| Micronized progesterone in continuous combination with oral estrogen | Active comparator | Capsule 100 mg mP (Utrogestan®) orally per day in continuous combination with 1 mg encapsulated estradiol (Estrofem®) Receives: Drug: Micronized progesterone in continuous combination with oral estrogen |
| Norethisterone acetate in continuous combination with oral estrogen | Active comparator | Capsule 0.5 mg NETA/ 1 mg estradiol (Activelle®) orally per day (encapsulated and identical to Estrofem® and one matched placebo to Utrogestan. Receives: Drug: Norethisterone acetate in continuous combination with oral estrogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammographic breast density
Percentage change in mammographic density
Measured: At baseline and 12 months treatment
Endometrial pathology
The incidence of endometrial pathology (hyperplasia or cancer)
Measured: At baseline and 12 months treatment
Secondary outcomes (11)
Breast cell proliferation
Percentage change in breast cell proliferation (proliferation marker Ki-67)
Measured: At baseline and 12 months treatment
Endometrial histology and cell proliferation
Percentage change in endometrial cell proliferation (histology classification and proliferation marker Ki-67)
Measured: At baseline and 12 months treatment
Endometrial thickness
Change in endometrial thickness by ultrasound
Measured: At baseline and 12 months treatment
Bleeding pattern
Bleeding patterns registered in diary (number of days of bleedings)
Measured: 3, 6, 9 and 12 months
Gene and protein expression of growth factors and apoptosis markers in breast and endometrial tissue
Change in gene and protein expression (proliferation and apoptosis markers)
Measured: At baseline and 12 months treatment
Depression (PHQ-9)
Change in score of PHQ-9: A 4-point scale where a larger value reflects more depression.
Measured: At baseline and 12 months treatment
Anxiety (HADS)
Change in score of HADS: A 4-point scale where a larger value reflects more anxiety.
Measured: At baseline and 12 months treatment
Quality of life (PGWB)
Change in score of PGWBI, where a where a higher score reflects more well-being.
Measured: At baseline and 12 months treatment
Menopausal symptoms (WHQ)
WHQ: A 4-point scale where a larger value reflects less menopausal symptoms.
Measured: At baseline and 12 months treatment
Serum levels of hormones, growth factors, lipids and coagulation factors.
Change in serum levels of these markers
Measured: At baseline and 12 months treatment
Gut- and vaginal microbiome
Change in microbiome diversity and relative abundance of different microbial species.
Measured: At baseline and 12 months treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start15 Mar 2022
- Primary completionSep 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Menopausal SymptomsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angelica Lindén Hirschberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Angelica Lindén Hirschberg, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586724
- Sponsor's protocol ID
- 2021-001624-17
- Status last verified
- Jun 2024
- First submitted
- 9 Oct 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be available to external researchers upon reasonable request after publication of the results and approval of the study management team.
Publications
Bofill Rodriguez M, Yong LN, Mirkov S, Bekos C, Lethaby A, Farquhar C. Long-term hormone therapy for perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2026 Sep 4;9(9):CD004143. doi: 10.1002/14651858.CD004143.pub7.
PubMed 42695385Bofill Rodriguez M, Yong LN, Mirkov S, Bekos C, Lethaby A, Farquhar C. Long-term hormone therapy for perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2025 Nov 27;11(11):CD004143. doi: 10.1002/14651858.CD004143.pub6.
PubMed 41307293Lundell C, Stergiopoulos N, Blomberg L, Ujvari D, Schuppe-Koistinen I, Kopp-Kallner H, Iliadis SI, Skalkidou A, Hirschberg AL. Breast and endometrial safety of micronised progesterone versus norethisterone acetate in menopausal hormone therapy (PROBES): study protocol of a double-blind randomised controlled trial. BMJ Open. 2024 Oct 23;14(10):e082749. doi: 10.1136/bmjopen-2023-082749.
PubMed 39448218
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Oral Micronized Progesterone Versus Norethisterone Acetate in Continuous Combination With Oral Estrogen as Menopausal Hormone Therapy - a Double-blind Randomized Study- PROBES Study (Progesterone Breast Endometrial Safety Study)
- ClinicalTrials.gov ID
- NCT05586724
- Acronym / sponsor ID
- 2021-001624-17
- Conditions
- Menopausal Symptoms
- Keywords
- Menopausal hormone therapy, Climacteric symptoms, Progesterone, Progestogens, Breast safety, Endometrial safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Angelica Lindén HirschbergUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Oct 2022 (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.
About one third of all women during menopausal transition have significant climacteric symptoms with considerable impact on quality of life. Meta-analysis has shown a beneficial risk profile with menopausal hormone therapy (MHT) for women 50 to 60 years. Still, there is a great need to find safe MHT able to control excessive endometrial stimulation by estrogen without stimulatory effects on the breast by the combination of estrogen/progestogen. Recent observational studies indicate a lower risk for breast cancer using micronized progesterone (mP) combined with estrogen but increased risk of endometrial cancer than by standard MHT. In a randomized trial, the balance between benefits and risks of mP vs. progestogens (norethisterone (NETA)) in combination with estrogen will be explored. For apparent reasons, long-term largescale clinical trials with endometrial and breast cancer as the primary endpoints, are not feasible. However, much knowledge can be obtained using relevant surrogate markers. Mammographic breast density is a strong risk factor for breast cancer, and endometrial hyperplasia is a strong risk factor for endometrial cancer. The primary objective is to compare the effects of one year treatment with mP versus progestogen, in combination with estradiol on mammographic breast density. Furthermore, to evaluate the effect of one year treatment with mP in continuous combination with estradiol on endometrial pathology (hyperplasia and cancer).
Detailed description
Postmenopausal women with climacteric symptoms will be randomized (1:1) to double blind treatment with oral mP or NETA in combination with oral estradiol. For the breast part, a power analysis revealed that 91 women/group would be sufficient to detect a significant difference in mammographic breast density between the groups at the 5%-level (two-sided) with 80% power. Considering the estimated rate of discontinuation and incomplete data, the target sample for the breast part is 260 patients. For the endometrial part, it is estimated that two or less women with serious adverse endometrial outcomes would result in an annual incidence of endometrial pathology of 0.67% or less with an upper bound of the one-sided 95% CI of 2.08% or less. Considering the estimated rate of discontinuation and incomplete data in the mP + estradiol group, the target sample for this part of the study is 390 patients. The total number of patients in part 1 and 2 will be 520.
Mammography at baseline and after 12 months of treatment will be assessed by independent radiologists at the Karolinska University Hospital blinded to treatment. In addition to visual judgment, a computer based quantitative assessment will be performed. All mammograms will be anonymous so that the operator will be unaware of the patient's identity and type of treatment. Percentage change in mammographic density will be evaluated and compared between the groups.
Endometrial biopsies at baseline and after 12 months of treatment will be evaluated by two independent pathologists at the Karolinska University Hospital for the incidence of endometrial pathology (hyperplasia or cancer) in the mP + estradiol group. Furthermore, immunostaining of the proliferation marker Ki-67, and other markers related to proliferation and apoptosis will be analyzed and compared between groups.
Different validated self-assessment questionnaires will be used for screening of mood disorders like depression and anxiety, as well as quality of life and menopausal symptoms. The Patient Health Questionnaire (PHQ-9) is a tool for screening, diagnosing, and measuring the severity of depression. The Hospital Anxiety and Depression Scale (HADS) is an instrument for detecting states of depression and anxiety in the setting of a hospital or medical outpatient clinic. Health related quality of life is measured using the Psychological General Well-Being Index (PGWB). The Women's Health Questionnaire (WHQ) measures menopausal symptoms. The change in scores will be compared between the groups.
Blood lipid profile, serum hormones, growth and metabolic factors, and coagulation factors will be analyzed.
The gut- and vaginal microbiome will be characterized and compared between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micronized progesterone in continuous combination with oral estrogen | Active comparator | Drug: Micronized progesterone in continuous combination with oral estrogenCapsule 100 mg mP (Utrogestan®) orally per day in continuous combination with 1 mg encapsulated estradiol (Estrofem®) |
| Norethisterone acetate in continuous combination with oral estrogen | Active comparator | Drug: Norethisterone acetate in continuous combination with oral estrogenCapsule 0.5 mg NETA/ 1 mg estradiol (Activelle®) orally per day (encapsulated and identical to Estrofem® and one matched placebo to Utrogestan. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy and naturally postmenopausal women (more than one year since last menstruation or FSH > 40 IE/L) with climacteric symptoms (sweating, hot flush and/or sleep problems) that adversely affect the quality of life
- Age 45-60 years
- BMI > 19 kg/m2 and ≤ 32 kg/m2
- Intact uterus
- In case of previous MHT use, washout 8 weeks for oral MHT and 4 weeks for transdermal MHT or local estrogen treatment before screening
Key exclusion criteria (12 listed)
- Previous history or risk factors for breast cancer, breast cancer in situ or abnormal mammogram at baseline as assessed clinically by a radiology expert
- Previous history or risk factors for endometrial cancer or hyperplasia or abnormal/proliferative endometrial biopsy at baseline
- Vaginal bleeding
- Any concomitant medical treatment except for well-controlled hypertension, non-insulin treated type 2 diabetes, asthma and hypothyroidism
- History or presence of or risk factor for cardiovascular disease including thromboembolic disorder or cerebrovascular disease
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 |
|---|---|---|
| Micronized progesterone in continuous combination with oral estrogenCapsule 100 mg mP (Utrogestan®) orally per day in continuous combination with 1 mg encapsulated estradiol (Estrofem®) | Drug | Micronized progesterone in continuous combination with oral estrogen |
| Norethisterone acetate in continuous combination with oral estrogenCapsule 0.5 mg NETA/ 1 mg estradiol (Activelle®) orally per day (encapsulated and identical to Estrofem® and one matched placebo to Utrogestan | Drug | Norethisterone acetate in continuous combination with oral estrogen |
Primary outcome
Mammographic breast density
Time frame: At baseline and 12 months treatment
Percentage change in mammographic density
Endometrial pathology
Time frame: At baseline and 12 months treatment
The incidence of endometrial pathology (hyperplasia or cancer)
11 secondary outcomes
Breast cell proliferation
Time frame: At baseline and 12 months treatment
Endometrial histology and cell proliferation
Time frame: At baseline and 12 months treatment
Endometrial thickness
Time frame: At baseline and 12 months treatment
Bleeding pattern
Time frame: 3, 6, 9 and 12 months
Gene and protein expression of growth factors and apoptosis markers in breast and endometrial tissue
Time frame: At baseline and 12 months treatment
Depression (PHQ-9)
Time frame: At baseline and 12 months treatment
Anxiety (HADS)
Time frame: At baseline and 12 months treatment
Quality of life (PGWB)
Time frame: At baseline and 12 months treatment
Menopausal symptoms (WHQ)
Time frame: At baseline and 12 months treatment
Serum levels of hormones, growth factors, lipids and coagulation factors.
Time frame: At baseline and 12 months treatment
Gut- and vaginal microbiome
Time frame: At baseline and 12 months treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 42695385Bofill Rodriguez M, Yong LN, Mirkov S, Bekos C, Lethaby A, Farquhar C. Long-term hormone therapy for perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2026 Sep 4;9(9):CD004143. doi: 10.1002/14651858.CD004143.pub7.
- Derived from this study: PubMed 41307293Bofill Rodriguez M, Yong LN, Mirkov S, Bekos C, Lethaby A, Farquhar C. Long-term hormone therapy for perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2025 Nov 27;11(11):CD004143. doi: 10.1002/14651858.CD004143.pub6.
- Derived from this study: PubMed 39448218Lundell C, Stergiopoulos N, Blomberg L, Ujvari D, Schuppe-Koistinen I, Kopp-Kallner H, Iliadis SI, Skalkidou A, Hirschberg AL. Breast and endometrial safety of micronised progesterone versus norethisterone acetate in menopausal hormone therapy (PROBES): study protocol of a double-blind randomised controlled trial. BMJ Open. 2024 Oct 23;14(10):e082749. doi: 10.1136/bmjopen-2023-082749.
- Individual participant dataSharing planned: Yes. Deidentified data will be available to external researchers upon reasonable request after publication of the results and approval of the study management team.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Micronized progesterone in continuous combination with oral estrogen and Norethisterone acetate in continuous combination with oral estrogen in people with Menopausal Symptoms, run by Angelica Lindén Hirschberg at 1 site in Sweden.
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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 4 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 Sweden. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angelica L Hirschberg, MD, PhD (+46 70 255 99 24, angelica.linden-hirschberg@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mammographic breast density (time frame: At baseline and 12 months treatment). 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 NCT05586724, which also lists 3 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 4 Jun 2024.