Primary DysmenorrheaNCT06835036
More Than Just p-Values: MCID for the VAS, MSQ and FEMD in Patients With Primary Dysmenorrhea
A study testing Exercise Treatment in people with Primary Dysmenorrhea and Pain, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the Minimal Clinically Important Difference (MCID) for the Visual Analog Scale (VAS), Menstrual Symptom Questionnaire (MSQ), and Functional and Emotional Measure of Dysmenorrhea (FEMD) in patients with primary dysmenorrhea (PwPD). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Primary Dysmenorrhea, Pain, Menstrual Discomfort
- What is being tested?
- Exercise Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2025to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of PD according to the "No. 345-Primary Dysmenorrhea Consensus Guideline",
- Pain level of three or more according to VAS during activity (moderate to severe pain),
- Patients aged 18-35 years (when PD becomes more prevalent),
- Regular menstrual cycle with a duration of 28±7 days,
- Nulliparity.
Who cannot join
- Historical background of chronic urogenital infections or drug use,
- Pregnancy,
- Secondary dysmenorrhoea caused by gynaecological conditions such as endometriosis, adenomyosis and uterine fibroids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: More Than Just p-Values: Minimal Clinically Important Difference for the Visual Analog Scale, Menstrual Symptom Questionnaire and Functional and Emotional Measure of Dysmenorrhea in Patients With Primary Dysmenorrhea
The aim of this study is to determine the Minimal Clinically Important Difference (MCID) for the Visual Analog Scale (VAS), Menstrual Symptom Questionnaire (MSQ), and Functional and Emotional Measure of Dysmenorrhea (FEMD) in patients with primary dysmenorrhea (PwPD).
Read the detailed description
100 PwPD will receive functional exercises three times a week for three menstrual cycles. Patients will be assessed on the most painful days of the first (baseline), second, and third menstrual cycles. The receiver operating characteristics (ROC) method and Gamma coefficient analysis will be applied to determine the responsiveness.
- Conditions
- Primary Dysmenorrhea, Pain, Menstrual Discomfort
- Being tested
- Exercise Treatment
- Keywords
- Dysmenorrhea, Menstruation, Visual Analog Scale, Minimal Clinically Important Difference, ROC Curve
- Medical subject headings
- Pain, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TreatmentOther
In this study, a functional exercise programme will be performed 3 days a week for 8 weeks in three cycles as previously recommended. This programme consisted of a 5-minute warm-up and a 45-minute exercise phase.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Treatment | Experimental | Each patient will receive a treatment protocol consisting of warm-up and functional exercises. Receives: Other: Exercise Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity in the lower abdomen, lower back and both thighs will be assessed using a 10 cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (excruciating pain). Pain levels were categorised as 0-2 (safe), 3-5 (acceptable) and 6-10 (risky).
Measured: Baseline (On the most painful day of the menstrual cycle before the intervention)
Pain Intensity
Pain intensity in the lower abdomen, lower back and both thighs will be assessed using a 10 cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (excruciating pain). Pain levels were categorised as 0-2 (safe), 3-5 (acceptable) and 6-10 (risky).
Measured: After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)
Pain Intensity
Pain intensity in the lower abdomen, lower back and both thighs will be assessed using a 10 cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (excruciating pain). Pain levels were categorised as 0-2 (safe), 3-5 (acceptable) and 6-10 (risky).
Measured: After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)
Secondary outcomes (8)
Menstrual Symptom Questionnaire (MSQ)
The Likert scale consists of 22 items, with responses rated on a 5-point range from 1 (never) to 5 (always). The scale includes three components: 'Negative Effects/Somatic Complaints' (items 1-13), 'Menstrual Pain Symptoms' (items 14-19), and 'Coping Methods' (items 20-22). The MSQ score is the mean value of all items in the scale. Increasing scores reflect more menstrual symptoms.
Measured: Baseline (On the most painful day of the menstrual cycle before the intervention)
Menstrual Symptom Questionnaire (MSQ)
The Likert scale consists of 22 items, with responses rated on a 5-point range from 1 (never) to 5 (always). The scale includes three components: 'Negative Effects/Somatic Complaints' (items 1-13), 'Menstrual Pain Symptoms' (items 14-19), and 'Coping Methods' (items 20-22). The MSQ score is the mean value of all items in the scale. Increasing scores reflect more menstrual symptoms.
Measured: After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)
Menstrual Symptom Questionnaire (MSQ)
The Likert scale consists of 22 items, with responses rated on a 5-point range from 1 (never) to 5 (always). The scale includes three components: 'Negative Effects/Somatic Complaints' (items 1-13), 'Menstrual Pain Symptoms' (items 14-19), and 'Coping Methods' (items 20-22). The MSQ score is the mean value of all items in the scale. Increasing scores reflect more menstrual symptoms.
Measured: After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)
Functional and Emotional Measure of Dysmenorrhea (FEMD)
The FEMD is a 14-item measurement tool that evaluates the functional and emotional aspects of dysmenorrhea using a 5-point Likert-type scale. The total scores on this scale range from 14 to 70, with higher scores indicating a more significant functional and emotional impact of dysmenorrhea on an individual.
Measured: Baseline (On the most painful day of the menstrual cycle before the intervention)
Functional and Emotional Measure of Dysmenorrhea (FEMD)
The FEMD is a 14-item measurement tool that evaluates the functional and emotional aspects of dysmenorrhea using a 5-point Likert-type scale. The total scores on this scale range from 14 to 70, with higher scores indicating a more significant functional and emotional impact of dysmenorrhea on an individual.
Measured: After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)
Functional and Emotional Measure of Dysmenorrhea (FEMD)
The FEMD is a 14-item measurement tool that evaluates the functional and emotional aspects of dysmenorrhea using a 5-point Likert-type scale. The total scores on this scale range from 14 to 70, with higher scores indicating a more significant functional and emotional impact of dysmenorrhea on an individual.
Measured: After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)
Global Rating Change (GRC)
The GRC comprised seven responses, ranging from 1 to 7, indicating "very much better," "much better," "slightly better," "no change," "slightly worse," "much worse," and "very much worse," respectively.
Measured: After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)
Global Rating Change (GRC)
The GRC comprised seven responses, ranging from 1 to 7, indicating "very much better," "much better," "slightly better," "no change," "slightly worse," "much worse," and "very much worse," respectively.
Measured: After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start15 Feb 2025
- Primary completion3 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In this prospective study, one treatment group was formed to receive exercise treatment.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artvin Coruh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Yıldız Kızkın, Artvin Coruh University
- Investigators
- Zeynep Yıldız Kızkın, Dr., Principal investigator, Artvin Coruh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835036
- Sponsor's protocol ID
- MCID
- Status last verified
- Aug 2025
- First submitted
- 10 Feb 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Habibi N, Huang MS, Gan WY, Zulida R, Safavi SM. Prevalence of Primary Dysmenorrhea and Factors Associated with Its Intensity Among Undergraduate Students: A Cross-Sectional Study. Pain Manag Nurs. 2015 Dec;16(6):855-61. doi: 10.1016/j.pmn.2015.07.001. Epub 2015 Aug 29.
PubMed 26328887Guy M, Foucher C, Juhel C, Rigaudier F, Mayeux G, Levesque A. Transcutaneous electrical neurostimulation relieves primary dysmenorrhea: A randomized, double-blind clinical study versus placebo. Prog Urol. 2022 Jul;32(7):487-497. doi: 10.1016/j.purol.2022.01.005. Epub 2022 Mar 3.
PubMed 35249825Chesney MA, Tasto DL. The development of the menstrual symptom questionnaire. Behav Res Ther. 1975 Oct;13(4):237-44. doi: 10.1016/0005-7967(75)90028-5. No abstract available.
PubMed 1238078Li L, Huangfu L, Chai H, He W, Song H, Zou X, Wang W. Development of a functional and emotional measure of dysmenorrhea (FEMD) in Chinese university women. Health Care Women Int. 2012;33(2):97-108. doi: 10.1080/07399332.2011.603863.
PubMed 22242651Husted JA, Cook RJ, Farewell VT, Gladman DD. Methods for assessing responsiveness: a critical review and recommendations. J Clin Epidemiol. 2000 May;53(5):459-68. doi: 10.1016/s0895-4356(99)00206-1.
PubMed 10812317Burnett M, Lemyre M. No. 345-Primary Dysmenorrhea Consensus Guideline. J Obstet Gynaecol Can. 2017 Jul;39(7):585-595. doi: 10.1016/j.jogc.2016.12.023.
PubMed 28625286Myles PS. The pain visual analog scale: linear or nonlinear? Anesthesiology. 2004 Mar;100(3):744; author reply 745. doi: 10.1097/00000542-200403000-00042. No abstract available.
PubMed 15108996Yahaya Y, Ismail AH, Shamsuddin NH. Primary dysmenorrhoea among reproductive-age women at Kuala Selangor health clinic: Prevalence and factors associated. Med J Malaysia. 2022 Sep;77(5):569-575.
PubMed 36169068Lopez-Liria R, Torres-Alamo L, Vega-Ramirez FA, Garcia-Luengo AV, Aguilar-Parra JM, Trigueros-Ramos R, Rocamora-Perez P. Efficacy of Physiotherapy Treatment in Primary Dysmenorrhea: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Jul 23;18(15):7832. doi: 10.3390/ijerph18157832.
PubMed 34360122Kirmizigil B, Demiralp C. Effectiveness of functional exercises on pain and sleep quality in patients with primary dysmenorrhea: a randomized clinical trial. Arch Gynecol Obstet. 2020 Jul;302(1):153-163. doi: 10.1007/s00404-020-05579-2. Epub 2020 May 15.
PubMed 32415471Greco NJ, Anderson AF, Mann BJ, Cole BJ, Farr J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May;38(5):891-902. doi: 10.1177/0363546509354163. Epub 2009 Dec 31.
PubMed 20044494Lehman LA, Velozo CA. Ability to detect change in patient function: responsiveness designs and methods of calculation. J Hand Ther. 2010 Oct-Dec;23(4):361-70; quiz 371. doi: 10.1016/j.jht.2010.05.003. Epub 2010 Jul 17.
PubMed 20638823
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- More Than Just p-Values: Minimal Clinically Important Difference for the Visual Analog Scale, Menstrual Symptom Questionnaire and Functional and Emotional Measure of Dysmenorrhea in Patients With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06835036
- Acronym / sponsor ID
- MCID
- Conditions
- Primary Dysmenorrhea, Pain, Menstrual Discomfort
- Keywords
- Dysmenorrhea, Menstruation, Visual Analog Scale, Minimal Clinically Important Difference, ROC Curve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Artvin Coruh UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 19 Feb 2025 (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 determine the Minimal Clinically Important Difference (MCID) for the Visual Analog Scale (VAS), Menstrual Symptom Questionnaire (MSQ), and Functional and Emotional Measure of Dysmenorrhea (FEMD) in patients with primary dysmenorrhea (PwPD).
Detailed description
100 PwPD will receive functional exercises three times a week for three menstrual cycles. Patients will be assessed on the most painful days of the first (baseline), second, and third menstrual cycles. The receiver operating characteristics (ROC) method and Gamma coefficient analysis will be applied to determine the responsiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this prospective study, one treatment group was formed to receive exercise treatment.
| Arm | Type | Receives |
|---|---|---|
| Exercise Treatment | Experimental | Other: Exercise TreatmentEach patient will receive a treatment protocol consisting of warm-up and functional exercises. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of PD according to the "No. 345-Primary Dysmenorrhea Consensus Guideline",
- Pain level of three or more according to VAS during activity (moderate to severe pain),
- Patients aged 18-35 years (when PD becomes more prevalent),
- Regular menstrual cycle with a duration of 28±7 days,
- Nulliparity.
Key exclusion criteria (3 listed)
- Historical background of chronic urogenital infections or drug use,
- Pregnancy,
- Secondary dysmenorrhoea caused by gynaecological conditions such as endometriosis, adenomyosis and uterine fibroids.
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 |
|---|---|---|
| Exercise TreatmentIn this study, a functional exercise programme will be performed 3 days a week for 8 weeks in three cycles as previously recommended. This programme consisted of a 5-minute warm-up and a 45-minute exercise phase. | Other | Exercise Treatment |
Primary outcome
Pain Intensity
Time frame: Baseline (On the most painful day of the menstrual cycle before the intervention)
Pain intensity in the lower abdomen, lower back and both thighs will be assessed using a 10 cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (excruciating pain). Pain levels were categorised as 0-2 (safe), 3-5 (acceptable) and 6-10 (risky).
Pain Intensity
Time frame: After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)
Pain intensity in the lower abdomen, lower back and both thighs will be assessed using a 10 cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (excruciating pain). Pain levels were categorised as 0-2 (safe), 3-5 (acceptable) and 6-10 (risky).
Pain Intensity
Time frame: After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)
Pain intensity in the lower abdomen, lower back and both thighs will be assessed using a 10 cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (excruciating pain). Pain levels were categorised as 0-2 (safe), 3-5 (acceptable) and 6-10 (risky).
8 secondary outcomes
Menstrual Symptom Questionnaire (MSQ)
Time frame: Baseline (On the most painful day of the menstrual cycle before the intervention)
Menstrual Symptom Questionnaire (MSQ)
Time frame: After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)
Menstrual Symptom Questionnaire (MSQ)
Time frame: After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)
Functional and Emotional Measure of Dysmenorrhea (FEMD)
Time frame: Baseline (On the most painful day of the menstrual cycle before the intervention)
Functional and Emotional Measure of Dysmenorrhea (FEMD)
Time frame: After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)
Functional and Emotional Measure of Dysmenorrhea (FEMD)
Time frame: After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)
Global Rating Change (GRC)
Time frame: After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention)
Global Rating Change (GRC)
Time frame: After the 8-week intervention (On the most painful day of the second menstrual cycle after the start of the intervention)
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 8 Sep 2025.
- Background: PubMed 26328887Habibi N, Huang MS, Gan WY, Zulida R, Safavi SM. Prevalence of Primary Dysmenorrhea and Factors Associated with Its Intensity Among Undergraduate Students: A Cross-Sectional Study. Pain Manag Nurs. 2015 Dec;16(6):855-61. doi: 10.1016/j.pmn.2015.07.001. Epub 2015 Aug 29.
- Background: PubMed 35249825Guy M, Foucher C, Juhel C, Rigaudier F, Mayeux G, Levesque A. Transcutaneous electrical neurostimulation relieves primary dysmenorrhea: A randomized, double-blind clinical study versus placebo. Prog Urol. 2022 Jul;32(7):487-497. doi: 10.1016/j.purol.2022.01.005. Epub 2022 Mar 3.
- Background: PubMed 1238078Chesney MA, Tasto DL. The development of the menstrual symptom questionnaire. Behav Res Ther. 1975 Oct;13(4):237-44. doi: 10.1016/0005-7967(75)90028-5. No abstract available.
- Background: PubMed 22242651Li L, Huangfu L, Chai H, He W, Song H, Zou X, Wang W. Development of a functional and emotional measure of dysmenorrhea (FEMD) in Chinese university women. Health Care Women Int. 2012;33(2):97-108. doi: 10.1080/07399332.2011.603863.
- Background: PubMed 10812317Husted JA, Cook RJ, Farewell VT, Gladman DD. Methods for assessing responsiveness: a critical review and recommendations. J Clin Epidemiol. 2000 May;53(5):459-68. doi: 10.1016/s0895-4356(99)00206-1.
- Background: PubMed 28625286Burnett M, Lemyre M. No. 345-Primary Dysmenorrhea Consensus Guideline. J Obstet Gynaecol Can. 2017 Jul;39(7):585-595. doi: 10.1016/j.jogc.2016.12.023.
- Background: PubMed 15108996Myles PS. The pain visual analog scale: linear or nonlinear? Anesthesiology. 2004 Mar;100(3):744; author reply 745. doi: 10.1097/00000542-200403000-00042. No abstract available.
- Background: PubMed 36169068Yahaya Y, Ismail AH, Shamsuddin NH. Primary dysmenorrhoea among reproductive-age women at Kuala Selangor health clinic: Prevalence and factors associated. Med J Malaysia. 2022 Sep;77(5):569-575.
- Background: PubMed 34360122Lopez-Liria R, Torres-Alamo L, Vega-Ramirez FA, Garcia-Luengo AV, Aguilar-Parra JM, Trigueros-Ramos R, Rocamora-Perez P. Efficacy of Physiotherapy Treatment in Primary Dysmenorrhea: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Jul 23;18(15):7832. doi: 10.3390/ijerph18157832.
- Background: PubMed 32415471Kirmizigil B, Demiralp C. Effectiveness of functional exercises on pain and sleep quality in patients with primary dysmenorrhea: a randomized clinical trial. Arch Gynecol Obstet. 2020 Jul;302(1):153-163. doi: 10.1007/s00404-020-05579-2. Epub 2020 May 15.
- Background: PubMed 20044494Greco NJ, Anderson AF, Mann BJ, Cole BJ, Farr J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May;38(5):891-902. doi: 10.1177/0363546509354163. Epub 2009 Dec 31.
- Background: PubMed 20638823Lehman LA, Velozo CA. Ability to detect change in patient function: responsiveness designs and methods of calculation. J Hand Ther. 2010 Oct-Dec;23(4):361-70; quiz 371. doi: 10.1016/j.jht.2010.05.003. Epub 2010 Jul 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Yıldız Kızkın, Dr. principal investigator
Artvin Coruh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Treatment in people with Primary Dysmenorrhea and Pain, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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 8 Sep 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 Turkey (Türkiye). 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?
Pain Intensity (time frame: Baseline (On the most painful day of the menstrual cycle before the intervention)). The study lists 3 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 NCT06835036, which also lists 12 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 8 Sep 2025.