Premenstrual Dysphoric DisorderPremensis-sNCT06496139
Emotion Regulation-based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder
A study testing Therapist-guided internet-delivered cognitive behavioural therapy in people with Premenstrual Dysphoric Disorder, run by Uppsala University at 1 site in Sweden.
Trial summary
Premenstrual dysphoric disorder (PMDD) is a debilitating cyclic mental disorder affecting about 2-5% of women of reproductive age. PMDD is characterised by recurring emotional, behavioural, cognitive, and somatic symptoms that arise during the luteal (premenstrual) phase of the menstrual cycle and remit shortly after… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Premenstrual Dysphoric Disorder
- What is being tested?
- Therapist-guided internet-delivered cognitive behavioural therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteSweden
- Study dates
- 14 Jul 2025to Jul 2028
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PMDD diagnosis according to DSM-5
- Menstrual cycle length between 23-34 days, i.e., 5-8 cycles in the last six months
- Sufficient proficiency in Swedish to comprehend the treatment materials
- Access to computer/tablet/mobile phone with internet connection
Who cannot join
- Breastfeeding or pregnancy during the previous three months
- Initiation of or change in treatment with antidepressants, benzodiazepines, contraceptives, or hormones during the last three months
- Current or history of a gynaecological disease (e.g., endometriosis, polycystic ovary syndrome) that may confound the results
- Ongoing or previous psychological treatment for premenstrual disorders
- Severe mental disorders that may interfere with the person's ability to complete the treatment or complicate the interpretation of results, e.g., psychosis, bipolar disorder, severe eating disorder, or severe depression
- Elevated suicide risk (e.g., recurrent active suicidal ideation, current suicide plans, previous suicide attempts).
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
Uppsala university
Uppsala, Uppsala County, 75656
Johanna Motilla Hoppe, PhD, +46735252205, johanna.motilla_hoppe@uu.se
Monica Buhrman, Associate professor, +4618-471 21 26, monica.buhrman@psyk.uu.se
About this study
Official title: Emotion Regulation Based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder: A Randomised Controlled Trial
Premenstrual dysphoric disorder (PMDD) is a debilitating cyclic mental disorder affecting about 2-5% of women of reproductive age. PMDD is characterised by recurring emotional, behavioural, cognitive, and somatic symptoms that arise during the luteal (premenstrual) phase of the menstrual cycle and remit shortly after the onset of menses. Although pharmacological interventions are available, many women experience residual symptoms, discontinue treatment or refrain from them because of side effects. Therefore, non-pharmacological treatment options are needed.
Preliminary evidence suggests that internet-delivered cognitive behavioural therapy (ICBT) is a promising candidate, but further research is warranted. Also, there is room for treatment improvement. Specifically, it has been suggested that components targeting emotional and interpersonal dysregulation should be incorporated into CBT for PMDD. The current study aims to assess the effects of an ICBT intervention for PMDD incorporating skills training in emotion regulation and interpersonal effectiveness in a randomised controlled trial (RCT).
Read the detailed description
The study is a parallel two-group RCT with 1:1 allocation to 8 weeks of a therapist-guided self-help ICBT for PMDD or a waitlist control group. Approximately 164 women (age 18-45) fulfilling the DSM-5 diagnostic criteria for PMDD will be randomly assigned.
Recruitment
Participants will be recruited from the general population using the following screening procedure.
- Web-based screening for PMDD (Premenstrual Screening Tool) and other eligibility criteria
- Clinical diagnostic (telephone) interview assessing preliminary PMDD diagnosis and psychiatric comorbidity
- Prospective daily ratings of premenstrual symptoms during two consecutive menstrual cycles using the Daily Report of Severity of Problems (DRSP).
Outcomes and Expected Results
Primary outcomes are pre- to post-treatment group differences in premenstrual symptoms and their impact on everyday life (prospective daily ratings, two menstrual cycles pre- and post-treatment) and PMDD-related psychological and functional impairment (retrospective ratings). Participants in the treatment group (vs waiting list) are expected to report a reduction in primary outcomes during the luteal (premenstrual) phase after treatment (vs baseline). No group differences in outcomes are expected during the follicular (post-menstrual) phase.
Secondary outcomes include treatment effects on quality of life (QoL) and difficulties in emotion regulation. Participants in the treatment group are expected to report higher QoL and lower levels of difficulties in emotion regulation after treatment (vs. baseline) than the waitlist control group. To assess long-term treatment effects, follow-up assessments will be conducted 6 and 12 months after treatment.
Health economic data will be collected for future health economic evaluations of the treatment.
Analysis
All randomised participants will be included in the intention-to-treat (ITT) population, regardless of whether they received or completed treatment. The per-protocol (PP) population will be a subgroup of the ITT population containing all participants without a major protocol violation. Sensitivity analyses will also be conducted with (1) participants who have completed at least four mandatory modules (modules 1-4) and (2) participants who have completed at least four mandatory modules and at least one of the optional lifestyle modules. To further explore potential differential effects of ICBT, exploratory analyses will be conducted for different symptom clusters (e.g., affective symptoms) and symptom trajectories in terms of onset and/or in combination with severity and severity peak. The relationship between difficulties in emotion regulation and improvement in primary outcomes will also be explored.
- Conditions
- Premenstrual Dysphoric Disorder
- Being tested
- Therapist-guided internet-delivered cognitive behavioural therapy
- Keywords
- Internet-delivered cognitive behavioural therapy, Emotion regulation, Premenstrual dysphoric disorder
- Medical subject headings
- Premenstrual Dysphoric Disorder, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapist-guided internet-delivered cognitive behavioural therapyBehavioural
The intervention consists of 8 weeks of therapist-guided self-help ICBT.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Therapist-guided self-help internet-delivered cognitive behavioural therapy for PMDD Receives: Behavioral: Therapist-guided internet-delivered cognitive behavioural therapy |
| Control group | No intervention | Waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group differences in premenstrual symptoms and their impact on everyday life during the luteal phase from baseline to post-treatment
This primary outcome is assessed with the Daily Report of Severity of Problems. (DRSP) The DRSP assesses premenstrual symptoms included in DSM-5 diagnostic criteria for PMDD and their impact on everyday life. Items are rated on a scale from 1-6. Baseline and post-treatment data consist of prospective daily DRSP ratings over two consecutive menstrual cycles, both before and after treatment. Follow-up assessments will include daily DRSP ratings over one menstrual cycle.
Measured: Baseline to post-treatment (daily ratings over two menstrual cycles [ca 56 days] starting 8 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment (daily ratings one cycle [ca 28 days] beginning 6 and 12 months post-treatment).
Group differences in PMDD-related psychological and functional impairment during the luteal phase from baseline to post-treatment
This outcome is assessed using the PMS Impact Questionnaire (PMS-I) which includes two subscales: (1) psychological impairment and (2) functional impairment. The PMS-I consists of 18 items (9 for each subscale) rated on a scale from 1-4 scale (max score 72, higher points indicating higher levels of psychological and functional impairment).
Measured: Baseline to post-treatment (first luteal phase after treatment, i.e., 8-10 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment. All assessements will be collected during luteal phase.
Secondary outcomes (4)
Group differences in quality of life during the luteal phase from baseline to post-treatment
Quality of life will be assessed using the Brunnsviken Brief Quality of Life scale (BBQ). The BBQ includes 12 items covering six life domains (recreation, philosophy of life, self-regard, creativity, learning and friendship), rated in terms of satisfaction and importance on scale from 0-4. Higher points indicate higher quality of life.
Measured: Baseline to post-treatment (first luteal phase after treatment, i.e., 8-10 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment. All assessements will be collected during luteal phase.
Group differences in difficulties in emotion regulation during the luteal phase from baseline to post-treatment.
Difficulties in emotion regulation will be assessed using the Difficulties in Emotion Regulation Scale (DERS-16). The DERS-16 measures five dimensions of emotion regulation in 16 items rated on a scale ranging from 1-5 (max score 80). High scores indicate more difficulties in emotion regulation.
Measured: Baseline to post-treatment (first luteal phase after treatment, i.e., 8-10 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment. All assessements will be collected during luteal phase.
Group differences in health-related quality of life during the luteal phase from baseline to post-treatment
Health-related quality of life will be assessed with the Assessing quality of life 8 dimensions (AQoL-8D). The AQoL-8D has 35 items and eight dimensions, including independent living, happiness, mental health, coping, relationships, self-worth, pain, and senses). Items have different response levels, each representing increasing levels of severity.
Measured: Baseline to post-treatment (first luteal phase after treatment, i.e., 8-10 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment. All assessements will be collected during luteal phase.
Remission (Full/Partial)
Remission will be determined based on post-treatment DRSP symptom ratings over two menstrual cycles post-treatment using the C-PASS algorithm with a 30% change criterion. Full remission is defined as not fulfilling the criteria for PMDD or other menstrual-related mood disorders (MRMD) according to the C-PASS algorithm. Partial remission is defined as fulfilling the C-PASS algorithm for an MRMD but not for PMDD. Follow-ups: In the 6 and 12-month post-treatment follow-ups, remission will be based on the C-PASS algorithm applied to one menstrual cycle, as daily ratings will only be collected during one cycle at follow-ups.
Measured: Post-treatment (daily ratings over two menstrual cycles [ca 56 days] starting 8 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment (daily ratings one cycle [ca 28 days] beginning 6 and 12 months post-treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start14 Jul 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premenstrual Dysphoric DisorderStudies of the same condition, open and under way.
- More trials run by Uppsala 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
- The study is a parallel two-group randomised controlled trial with 1:1 allocation to 8 weeks of therapist-guided self-help ICBT (TG) or a waitlist control group (WL)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Friedrich-Alexander-Universität Erlangen-Nürnberg, Utah State University, Linkoeping University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496139
- Sponsor's protocol ID
- 2023-00655-01
- Other IDs
- 2023
- Acronym
- Premensis-s
- Status last verified
- Jul 2025
- First submitted
- 29 May 2024
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be available upon reasonable request following trial completion and publication of results.
Publications
Hoppe JM, Weise C, Kleinstaeuber M, Skalkidou A, Vegelius J, Comasco E, Grondal M, Kaltsouni E, Sundstrom F, Sampaio F, Andersson G, Buhrman M. Emotion regulation-based internet-delivered cognitive behavioural therapy for premenstrual dysphoric disorder: study protocol for a randomised controlled trial in Sweden. BMJ Open. 2025 Jan 22;15(1):e091649. doi: 10.1136/bmjopen-2024-091649.
PubMed 39843366
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Regulation Based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06496139
- Acronym / sponsor ID
- Premensis-s / 2023-00655-01
- Conditions
- Premenstrual Dysphoric Disorder
- Keywords
- Internet-delivered cognitive behavioural therapy, Emotion regulation, Premenstrual dysphoric disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Friedrich-Alexander-Universität Erlangen-Nürnberg, Utah State University, Linkoeping University
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 11 Jul 2024 (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.
Premenstrual dysphoric disorder (PMDD) is a debilitating cyclic mental disorder affecting about 2-5% of women of reproductive age. PMDD is characterised by recurring emotional, behavioural, cognitive, and somatic symptoms that arise during the luteal (premenstrual) phase of the menstrual cycle and remit shortly after the onset of menses. Although pharmacological interventions are available, many women experience residual symptoms, discontinue treatment or refrain from them because of side effects. Therefore, non-pharmacological treatment options are needed.
Preliminary evidence suggests that internet-delivered cognitive behavioural therapy (ICBT) is a promising candidate, but further research is warranted. Also, there is room for treatment improvement. Specifically, it has been suggested that components targeting emotional and interpersonal dysregulation should be incorporated into CBT for PMDD. The current study aims to assess the effects of an ICBT intervention for PMDD incorporating skills training in emotion regulation and interpersonal effectiveness in a randomised controlled trial (RCT).
Detailed description
The study is a parallel two-group RCT with 1:1 allocation to 8 weeks of a therapist-guided self-help ICBT for PMDD or a waitlist control group. Approximately 164 women (age 18-45) fulfilling the DSM-5 diagnostic criteria for PMDD will be randomly assigned.
Recruitment
Participants will be recruited from the general population using the following screening procedure.
- Web-based screening for PMDD (Premenstrual Screening Tool) and other eligibility criteria
- Clinical diagnostic (telephone) interview assessing preliminary PMDD diagnosis and psychiatric comorbidity
- Prospective daily ratings of premenstrual symptoms during two consecutive menstrual cycles using the Daily Report of Severity of Problems (DRSP).
Outcomes and Expected Results
Primary outcomes are pre- to post-treatment group differences in premenstrual symptoms and their impact on everyday life (prospective daily ratings, two menstrual cycles pre- and post-treatment) and PMDD-related psychological and functional impairment (retrospective ratings). Participants in the treatment group (vs waiting list) are expected to report a reduction in primary outcomes during the luteal (premenstrual) phase after treatment (vs baseline). No group differences in outcomes are expected during the follicular (post-menstrual) phase.
Secondary outcomes include treatment effects on quality of life (QoL) and difficulties in emotion regulation. Participants in the treatment group are expected to report higher QoL and lower levels of difficulties in emotion regulation after treatment (vs. baseline) than the waitlist control group. To assess long-term treatment effects, follow-up assessments will be conducted 6 and 12 months after treatment.
Health economic data will be collected for future health economic evaluations of the treatment.
Analysis
All randomised participants will be included in the intention-to-treat (ITT) population, regardless of whether they received or completed treatment. The per-protocol (PP) population will be a subgroup of the ITT population containing all participants without a major protocol violation. Sensitivity analyses will also be conducted with (1) participants who have completed at least four mandatory modules (modules 1-4) and (2) participants who have completed at least four mandatory modules and at least one of the optional lifestyle modules. To further explore potential differential effects of ICBT, exploratory analyses will be conducted for different symptom clusters (e.g., affective symptoms) and symptom trajectories in terms of onset and/or in combination with severity and severity peak. The relationship between difficulties in emotion regulation and improvement in primary outcomes will also be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a parallel two-group randomised controlled trial with 1:1 allocation to 8 weeks of therapist-guided self-help ICBT (TG) or a waitlist control group (WL)
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Therapist-guided internet-delivered cognitive behavioural therapyTherapist-guided self-help internet-delivered cognitive behavioural therapy for PMDD |
| Control group | No intervention | –Waiting list |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- PMDD diagnosis according to DSM-5
- Menstrual cycle length between 23-34 days, i.e., 5-8 cycles in the last six months
- Sufficient proficiency in Swedish to comprehend the treatment materials
- Access to computer/tablet/mobile phone with internet connection
Key exclusion criteria (6 listed)
- Breastfeeding or pregnancy during the previous three months
- Initiation of or change in treatment with antidepressants, benzodiazepines, contraceptives, or hormones during the last three months
- Current or history of a gynaecological disease (e.g., endometriosis, polycystic ovary syndrome) that may confound the results
- Ongoing or previous psychological treatment for premenstrual disorders
- Severe mental disorders that may interfere with the person's ability to complete the treatment or complicate the interpretation of results, e.g., psychosis, bipolar disorder, severe eating disorder, or severe depression
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 |
|---|---|---|
| Therapist-guided internet-delivered cognitive behavioural therapyThe intervention consists of 8 weeks of therapist-guided self-help ICBT. | Behavioural | Treatment group |
Primary outcome
Group differences in premenstrual symptoms and their impact on everyday life during the luteal phase from baseline to post-treatment
Time frame: Baseline to post-treatment (daily ratings over two menstrual cycles [ca 56 days] starting 8 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment (daily ratings one cycle [ca 28 days] beginning 6 and 12 months post-treatment).
This primary outcome is assessed with the Daily Report of Severity of Problems. (DRSP) The DRSP assesses premenstrual symptoms included in DSM-5 diagnostic criteria for PMDD and their impact on everyday life. Items are rated on a scale from 1-6. Baseline and post-treatment data consist of prospective daily DRSP ratings over two consecutive menstrual cycles, both before and after treatment. Follow-up assessments will include daily DRSP ratings over one menstrual cycle.
Group differences in PMDD-related psychological and functional impairment during the luteal phase from baseline to post-treatment
Time frame: Baseline to post-treatment (first luteal phase after treatment, i.e., 8-10 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment. All assessements will be collected during luteal phase.
This outcome is assessed using the PMS Impact Questionnaire (PMS-I) which includes two subscales: (1) psychological impairment and (2) functional impairment. The PMS-I consists of 18 items (9 for each subscale) rated on a scale from 1-4 scale (max score 72, higher points indicating higher levels of psychological and functional impairment).
4 secondary outcomes
Group differences in quality of life during the luteal phase from baseline to post-treatment
Time frame: Baseline to post-treatment (first luteal phase after treatment, i.e., 8-10 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment. All assessements will be collected during luteal phase.
Group differences in difficulties in emotion regulation during the luteal phase from baseline to post-treatment.
Time frame: Baseline to post-treatment (first luteal phase after treatment, i.e., 8-10 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment. All assessements will be collected during luteal phase.
Group differences in health-related quality of life during the luteal phase from baseline to post-treatment
Time frame: Baseline to post-treatment (first luteal phase after treatment, i.e., 8-10 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment. All assessements will be collected during luteal phase.
Remission (Full/Partial)
Time frame: Post-treatment (daily ratings over two menstrual cycles [ca 56 days] starting 8 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment (daily ratings one cycle [ca 28 days] beginning 6 and 12 months post-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 31 Jul 2025.
- Background: PubMed 39843366Hoppe JM, Weise C, Kleinstaeuber M, Skalkidou A, Vegelius J, Comasco E, Grondal M, Kaltsouni E, Sundstrom F, Sampaio F, Andersson G, Buhrman M. Emotion regulation-based internet-delivered cognitive behavioural therapy for premenstrual dysphoric disorder: study protocol for a randomised controlled trial in Sweden. BMJ Open. 2025 Jan 22;15(1):e091649. doi: 10.1136/bmjopen-2024-091649.
- Individual participant dataSharing planned: Yes. De-identified data will be available upon reasonable request following trial completion and publication of results.
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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 study testing Therapist-guided internet-delivered cognitive behavioural therapy in people with Premenstrual Dysphoric Disorder, run by Uppsala University 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 4 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: looking for participants now, as of the sponsor's last update on 31 Jul 2025. 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.
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 Johanna Motilla Hoppe, PhD (+46735252205, johanna.motilla_hoppe@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group differences in premenstrual symptoms and their impact on everyday life during the luteal phase from baseline to post-treatment (time frame: Baseline to post-treatment (daily ratings over two menstrual cycles [ca 56 days] starting 8 weeks after baseline). Follow-up assessments at 6 and 12 months post-treatment (daily ratings one cycle [ca 28 days] beginning 6 and 12 months post-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 NCT06496139, which also lists 1 linked publication.
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 31 Jul 2025.