Congenital Adrenal HyperplasiaPhase 3CONnECTNCT05063994
Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
A Phase 3 study testing Chronocort and Cortef in people with Congenital Adrenal Hyperplasia, run by Neurocrine UK Limited at 21 sites in 3 countries.
Trial summary
This study is a randomized, double-blind, active-controlled, phase III study of Chronocort® compared with immediate-release hydrocortisone replacement therapy in participants aged 16 years and over with Congenital Adrenal Hyperplasia. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Congenital Adrenal Hyperplasia
- What is being tested?
- Chronocort and Cortef
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 24 May 2022to 2 Feb 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female participants must be aged 16 years or older at the time of signing the informed consent/assent.
- In participants aged <18 years, height velocity must be less than 2 cm/year in the last year and puberty must be completed (Tanner stage V).
- Participants with known classic CAH due to 21 hydroxylase deficiency diagnosed in childhood with documented (at any time) elevated 17-OHP and with or without elevated A4 and currently treated with hydrocortisone, prednisone, prednisolone or dexamethasone (or a combination of the aforementioned glucocorticoids) and on stable glucocorticoid therapy for a minimum of 3 months.
- Participants who are receiving fludrocortisone must be on a documented stable dose for a minimum of 3 months prior to enrollment and must have stable renin levels at screening.
- Female participants of childbearing potential and all male participants must agree to the use of an accepted method of contraception during the study.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and she is either not a woman of childbearing potential (WOCBP) or has a negative pregnancy test at entry into the study. Note: females presenting with oligomenorrhea or amenorrhea who are aged ≤55 years should be considered potentially fertile and therefore should undergo pregnancy testing like all other female participants.
- Capable of giving signed informed consent/assent which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- Clinical or biochemical evidence of hepatic or renal disease e.g. creatinine >2 times the upper limit of normal (ULN) or elevated liver function tests (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >2 times the ULN).
- History of bilateral adrenalectomy.
- History of malignancy (other than basal cell carcinoma successfully treated >26 weeks prior to entry into the study).
- Participants who have type 1 diabetes or receive regular insulin, have uncontrolled diabetes, or have a screening HbA1c greater than 8%.
- Persistent signs of adrenal insufficiency or the participant does not tolerate treatment at the end of the 4-week run-in period.
- Participants with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the study.
Show all 18Show fewer
- Participants on regular daily inhaled, topical, nasal or oral steroids for any indication other than CAH.
- Co-morbid condition requiring daily administration of a medication or consumption of any material that interferes with the metabolism of glucocorticoids.
- Participants who are receiving <10 mg hydrocortisone dose at screening or the hydrocortisone dose equivalent.
- Participants anticipating regular prophylactic use of additional steroids e.g. for strenuous exercise.
- Participation in another clinical study of an investigational or licensed drug or device within the 12 weeks prior to screening.
- Inclusion in any natural history or translational research study that would require evaluation of androgen levels during the study period outside of this protocol's assessments.
- Participants who have previously been exposed to Chronocort in any Diurnal study.
- Participants who routinely work night shifts and so do not sleep during the usual night-time hours.
- Participants, who in the opinion of the Investigator, will be unable to comply with the requirements of the protocol.
- Participants with a known hypersensitivity to any of the components of the Chronocort capsules, the Cortef tablets, or the placebo capsules.
- Participants with congenital galactosemia, malabsorption of glucose and galactose, or who are lactase deficient.
- Participants with a body weight of 45 kg or less.
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
United States11 sites
Diurnal Investigational Site in Michigan
Ann Arbor, Michigan, 48109
Diurnal Investigational Site in Maryland
Bethesda, Maryland, 20892-1932
Diurnal Investigational Site in Dallas
Dallas, Texas, 75235
Diurnal Investigational Site in Iowa
Iowa City, Iowa, 52224
Diurnal Investigational Site in Jacksonville
Jacksonville, Florida, 32207
Diurnal Investigational Site in Nevada
Las Vegas, Nevada, 89148
Diurnal Investigational Site in Los Angeles
Los Angeles, California, 90027
Diurnal Investigational Site in Milwaukee
Milwaukee, Wisconsin, 53226
Diurnal Investigational Site in Orange
Orange, California, 92868
Diurnal Investigational Site in Rochester
Rochester, Minnesota, 55901
Diurnal Investigational Site in Seattle
Seattle, Washington, 98105
France6 sites
Diurnal Investigational Site in Pessac
Bordeaux, 33604
Diurnal Investigational Site in Caen
Caen, Normandy, 14033
Diurnal Investigational Site in Bron
Lyon, 69677
Diurnal Investigational Site in Paris
Paris, 75651
Diurnal Investigational Site in Toulouse (Children's Hospital)
Toulouse, 31059
Diurnal Investigational Site in Toulouse
Toulouse, 31059
Japan4 sites
Diurnal Investigational Site in Yushima
Bunkyō-Ku, Tokyo, 113-8519
Diurnal Investigational Site in Okura
Setagaya-Ku, Tokyo, 157-8535
Diurnal Investigational Site in Toyama
Shinjuku-Ku, Tokyo, 162-8655
Diurnal Investigational Site in Asahi-ku
Yokohama, Kanagawa, 241-0811
About this study
Official title: A Randomized, Double-Blind, Active-Controlled, Phase 3 Study of Chronocort Compared With Immediate-Release Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
This study is a randomized, double-blind, active-controlled, phase III study of Chronocort® compared with immediate-release hydrocortisone replacement therapy in participants aged 16 years and over with Congenital Adrenal Hyperplasia.
Read the detailed description
The study will compare the efficacy, safety and tolerability of twice daily Chronocort with twice daily immediate release hydrocortisone replacement therapy (IRHC) (Cortef®) in participants aged 16 years and over with known classic Congenital Adrenal Hyperplasia (CAH) due to 21 hydroxylase deficiency.
- Conditions
- Congenital Adrenal Hyperplasia
- Being tested
- Chronocort, Cortef, Placebo
- Medical subject headings
- Adrenal Hyperplasia, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChronocortDrug
Also called Hydrocortisone modified-release
Over-encapsulated hydrocortisone modified-release capsule for oral administration.
CortefDrug
Also called Immediate-release hydrocortisone, IRHC
Over-encapsulated hydrocortisone immediate-release tablet for oral administration.
PlaceboOther
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Chronocort | Experimental | Participants received Chronocort at a starting dose of 30 milligrams (mg), with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding. Receives: Drug: Chronocort; Other: Placebo |
| Cortef | Active comparator | Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding. Receives: Drug: Cortef; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Were Biochemical Responders at Week 28
Biochemical response was defined as a participant who a) was in biochemical control at the 08:00 assessment and b) was receiving a total daily dose of hydrocortisone of not more than 25 mg if the participant was in biochemical control at baseline or not more than 30 mg if the participant was not in biochemical control at baseline.
Biochemical control was defined as both a 17-OHP concentration equal to or below the upper limit for optimal control (1200 ng/dL [36.4 nmol/L]) and an A4 concentration equal to or below the upper limit of the reference range (150 ng/dL [5.2 nmol/L] for men and 200 ng/dL [7.0 nmol/L] for women).
Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Measured: Week 28
Secondary outcomes (14)
Percentage of Participants Who Were Dose Responders at Week 28
Dose response was defined as a participant who a) was receiving a total daily dose of hydrocortisone of not more than 25 mg and b) was in biochemical control at the 08:00 assessment.
Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Measured: Week 28
Total Daily Dose of Hydrocortisone at Week 28
Least squares (LS) mean was assessed using mixed model repeated measures (MMRM).
Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Measured: Week 28
Number of Participants in Biochemical Control
Biochemical control was defined as both a 17-OHP concentration (assessed at 08:00) equal to or below the upper limit for optimal control (1200 ng/dL [36.4 nmol/L]) and an A4 concentration equal to or below the upper limit of the reference range (150 ng/dL [5.2 nmol/L] for men and 200 ng/dL [7.0 nmol/L] for women).
Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Measured: Baseline and Week 28
Change From Baseline in Mean of 08:00 and 13:00 17-OHP Levels at Week 28
LS mean was assessed using analysis of covariance (ANCOVA). Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Measured: Baseline, Week 28
Change From Baseline in Mean of 08:00 and 13:00 A4 Levels at Week 28
LS mean was assessed using ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Measured: Baseline, Week 28
Number of Participants With Menstrual Regularity (Females of Childbearing Potential Only) at Week 28
Data are presented for the number of participants with more than monthly menstrual cycles, monthly menstrual cycles, and number of participants with oligomenorrhoea and amenorrhoea. Oligomenorrhoea was defined as fewer than 9 menstrual cycles per year or cycle length >35 days and amenorrhoea as absent menses for ≥ 3 months.
Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Measured: Week 28
Change From Baseline in Luteinizing Hormone Levels (Males Only) at Week 28
LS mean was assessed using ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Measured: Baseline, Week 28
Percent Change From Baseline in Size of Testicular Adrenal Rest Tumors at Week 28 (Males Only)
Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Measured: Week 28
Change From Baseline in Hirsutism at Week 28 Using the Ferriman-Gallwey Score (Females Only) at Week 28
Ferriman-Gallwey score is a method used to assess and quantify hirsutism in women. A total score < 8 is considered normal whereas a score of 8 to 15 indicates mild hirsutism. A score >15 indicates moderate or severe hirsutism. The Ferriman-Gallwey score ranged from 0 to 36. Higher score indicated more hirsutism. Change from baseline is reported (negative change from baseline indicated improvement).
LS mean was assessed using ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Measured: Baseline, Week 28
Change From Baseline in Acne Using the Global Evaluation Acne (GEA) Scale (Females Only) at Week 28
Acne severity was assessed according to GEA scale, which ranged from 0 (Clear. No lesions) to 5 (Very severe). Higher score indicated higher severity of acne. Change from baseline is reported (negative change from baseline indicated improvement).
LS mean was assessed using ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Measured: Baseline, Week 28
Change From Baseline in Glycated Hemoglobin (HbA1c) Percent Levels at Week 28
LS mean was assessed by ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Measured: Baseline, Week 28
Change From Baseline in Waist Circumference at Week 28
LS mean was assessed using ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Measured: Baseline, Week 28
Change From Baseline in Body Weight at Week 28
LS mean was assessed by ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Measured: Baseline, Week 28
Change From Baseline Quality of Life Using the Self-completed Medical Outcome Study 36-Item Short Form Health Survey (SF-36) Total Score for the Physical and Mental Components and the Sub-domain of Vitality at Week 28
SF-36 evaluates aspects of functional health and well-being. The physical component has 4 sub-scales: physical function, role limitations due to physical problems, pain, and general health perception; and the mental component has 4 sub-scales: vitality, social function, role limitations due to emotional problems, and mental health. Total scores for the physical and mental component are presented as well as the sub-scale score for vitality. Scores were summarized and transformed into a range from 0 to 100; 0=worst, and 100=best outcome. Higher scores indicated better outcome. Change from baseline is reported (positive change from baseline indicated improvement).
LS mean was assessed by ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Measured: Baseline, Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start24 May 2022
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congenital Adrenal HyperplasiaStudies 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Principal Investigator, Principal investigator, Immedica Pharma AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063994
- Sponsor's protocol ID
- DIUR-014
- Acronym
- CONnECT
- Status last verified
- Sep 2026
- First submitted
- 28 May 2021
- Last updated
- 2 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active-Controlled, Phase 3 Study of Chronocort Compared With Immediate-Release Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
- ClinicalTrials.gov ID
- NCT05063994
- Acronym / sponsor ID
- CONnECT / DIUR-014
- Conditions
- Congenital Adrenal Hyperplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Neurocrine UK LimitedIndustry (pharma, biotech, devices)
- Study start
- 24 May 2022 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Posted 24 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, double-blind, active-controlled, phase III study of Chronocort® compared with immediate-release hydrocortisone replacement therapy in participants aged 16 years and over with Congenital Adrenal Hyperplasia.
Detailed description
The study will compare the efficacy, safety and tolerability of twice daily Chronocort with twice daily immediate release hydrocortisone replacement therapy (IRHC) (Cortef®) in participants aged 16 years and over with known classic Congenital Adrenal Hyperplasia (CAH) due to 21 hydroxylase deficiency.
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 |
|---|---|---|
| Chronocort | Experimental | Drug: Chronocort, Other: PlaceboParticipants received Chronocort at a starting dose of 30 milligrams (mg), with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding. |
| Cortef | Active comparator | Drug: Cortef, Other: PlaceboParticipants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female participants must be aged 16 years or older at the time of signing the informed consent/assent.
- In participants aged <18 years, height velocity must be less than 2 cm/year in the last year and puberty must be completed (Tanner stage V).
- Participants with known classic CAH due to 21 hydroxylase deficiency diagnosed in childhood with documented (at any time) elevated 17-OHP and with or without elevated A4 and currently treated with hydrocortisone, prednisone, prednisolone or dexamethasone (or a combination of the aforementioned glucocorticoids) and on stable glucocorticoid therapy for a minimum of 3 months.
- Participants who are receiving fludrocortisone must be on a documented stable dose for a minimum of 3 months prior to enrollment and must have stable renin levels at screening.
- Female participants of childbearing potential and all male participants must agree to the use of an accepted method of contraception during the study.
Key exclusion criteria (18 listed)
- Clinical or biochemical evidence of hepatic or renal disease e.g. creatinine >2 times the upper limit of normal (ULN) or elevated liver function tests (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >2 times the ULN).
- History of bilateral adrenalectomy.
- History of malignancy (other than basal cell carcinoma successfully treated >26 weeks prior to entry into the study).
- Participants who have type 1 diabetes or receive regular insulin, have uncontrolled diabetes, or have a screening HbA1c greater than 8%.
- Persistent signs of adrenal insufficiency or the participant does not tolerate treatment at the end of the 4-week run-in period.
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 |
|---|---|---|
| ChronocortAlso: Hydrocortisone modified-releaseOver-encapsulated hydrocortisone modified-release capsule for oral administration. | Drug | Chronocort |
| CortefAlso: Immediate-release hydrocortisone, IRHCOver-encapsulated hydrocortisone immediate-release tablet for oral administration. | Drug | Cortef |
| PlaceboMatching placebo | Other | Chronocort, Cortef |
Primary outcome
Percentage of Participants Who Were Biochemical Responders at Week 28
Time frame: Week 28
Biochemical response was defined as a participant who a) was in biochemical control at the 08:00 assessment and b) was receiving a total daily dose of hydrocortisone of not more than 25 mg if the participant was in biochemical control at baseline or not more than 30 mg if the participant was not in biochemical control at baseline. Biochemical control was defined as both a 17-OHP concentration equal to or below the upper limit for optimal control (1200 ng/dL [36.4 nmol/L]) and an A4 concentration equal to or below the upper limit of the reference range (150 ng/dL [5.2 nmol/L] for men and 200 ng/dL [7.0 nmol/L] for women). Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
14 secondary outcomes
Percentage of Participants Who Were Dose Responders at Week 28
Time frame: Week 28
Total Daily Dose of Hydrocortisone at Week 28
Time frame: Week 28
Number of Participants in Biochemical Control
Time frame: Baseline and Week 28
Change From Baseline in Mean of 08:00 and 13:00 17-OHP Levels at Week 28
Time frame: Baseline, Week 28
Change From Baseline in Mean of 08:00 and 13:00 A4 Levels at Week 28
Time frame: Baseline, Week 28
Number of Participants With Menstrual Regularity (Females of Childbearing Potential Only) at Week 28
Time frame: Week 28
Change From Baseline in Luteinizing Hormone Levels (Males Only) at Week 28
Time frame: Baseline, Week 28
Percent Change From Baseline in Size of Testicular Adrenal Rest Tumors at Week 28 (Males Only)
Time frame: Week 28
Change From Baseline in Hirsutism at Week 28 Using the Ferriman-Gallwey Score (Females Only) at Week 28
Time frame: Baseline, Week 28
Change From Baseline in Acne Using the Global Evaluation Acne (GEA) Scale (Females Only) at Week 28
Time frame: Baseline, Week 28
Change From Baseline in Glycated Hemoglobin (HbA1c) Percent Levels at Week 28
Time frame: Baseline, Week 28
Change From Baseline in Waist Circumference at Week 28
Time frame: Baseline, Week 28
Change From Baseline in Body Weight at Week 28
Time frame: Baseline, Week 28
Change From Baseline Quality of Life Using the Self-completed Medical Outcome Study 36-Item Short Form Health Survey (SF-36) Total Score for the Physical and Mental Components and the Sub-domain of Vitality at Week 28
Time frame: Baseline, Week 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Principal Investigator principal investigator
Immedica Pharma AB
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chronocort and Cortef in people with Congenital Adrenal Hyperplasia, run by Neurocrine UK Limited at 21 sites in 3 countries.
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 7 inclusion and 18 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 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, France, Japan. 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?
Yes. Results are posted in the registry (first posted 24 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Were Biochemical Responders at Week 28 (time frame: Week 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2026.