Trial · NCT07894406
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in menstrual pain intensity VAS from Cycle 0 to Cycle 2. | Menstrual days 1-3 of Cycle 0 (baseline, no study product) and Cycle 2. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively. | Mean daily Visual Analogue Scale (VAS) pain intensity across menstrual days 1-3, Change from Cycle 0 to Cycle 2. VAS consists of a 100 mm line anchored by "no pain" (0 cm) and "pain as bad as it could be" (10 cm); scores reported in cm (0-10). |
| Secondary | Change in menstrual pain intensity VAS from Cycle 0 to Cycle 1. | Menstrual days 1-3 of Cycle 0 (baseline, no study product) and Cycle 1 (3 days after first dose). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively. | Mean daily Visual Analogue Scale (VAS) pain intensity across menstrual days 1-3, Change from Cycle 0 to Cycle 1. VAS consists of a 100 mm line anchored by "no pain" (0 cm) and "pain as bad as it could be" (10 cm); scores reported in cm (0-10). |
| Secondary | Change in menstrual pain duration (hours) from Cycle 0 to Cycle 1 and Cycle 2. | Daily throughout each menstruation period (Cycles 0-1-2), with previous-day symptom recall. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively. | Participants will report the total number of hours they experienced menstrual pain over the past 24 hours. Numeric entry : 0-24h. |
| Secondary | Change in menstrual rescue medicine use from Cycle 0 to Cycle 1 and Cycle 2. | Daily throughout each menstruation period (Cycles 0-1-2), with previous-day symptom recall. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively. | Participants will report whether they used acetaminophen over the past 24 hours. If yes, participants will report the dose (500 mg or 1000 mg) and the number of doses taken during the past 24 hours (1-4 doses). |
| Secondary | Change in menstrual bleeding flow from Cycle 0 to Cycle 1 and Cycle 2. | Daily throughout each menstruation period (Cycles 0-1-2), with previous-day symptom recall. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively. | Menstrual flow over the past 24 hours will be assessed using a single categorical item, with response options of light, moderate, heavy, or my period has ended. |
| Secondary | Change in the Verbal Multidimensional Scoring system (VMS) from Cycle 0 to Cycle 1 and Cycle 2. | Retrospective assessment of the preceding menstrual period, completed the day after menstruation ends (Cycles 0, 1, and 2). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively. | VMS provides categorical assessment of menstrual pain severity across four grades (0-3): Painless menstruation =0, menstruation with pain but rare use of analgesics or limitation of activities =1, menstruation with moderate pain with influence on daily activities and use of analgesics with relief =2, and menstruation with severe pain with significant limitations on daily activities, ineffective use of analgesics, and such symptoms as headache, tenderness, nausea, vomiting, and diarrhea =3. Participants select the grade description that best matches their experience during the entire past menstruation phase. |
| Secondary | Change in menstrual gastrointestinal symptoms NRS from Cycle 0 to Cycle 1 and Cycle 2. | Retrospective assessment of the preceding menstrual period, completed the day after menstruation ends (Cycles 0, 1, and 2). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively. | Individual gastrointestinal symptoms, including bloating, nausea, and transit disturbances (diarrhea/constipation), will be evaluated using a Numeric Rating Scale (NRS; 0 = none, 10 = worst possible). Scores will be analyzed on a per-item basis. |
| Secondary | Change in menstrual physical symptoms NRS from Cycle 0 to Cycle 1 and Cycle 2. | Retrospective assessment of the preceding menstrual period, completed the day after menstruation ends (Cycles 0, 1, and 2). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively. | Individual physical symptoms, including headache, fatigue, and muscle/bone/joint pain, will be evaluated using a Numeric Rating Scale (NRS; 0 = none, 10 = worst possible). Scores will be analyzed on a per-item basis. |
| Secondary | Change in menstrual quality of life impact from Cycle 0 to Cycle 1 and Cycle 2. | Retrospective assessment of the preceding menstrual period, completed the day after menstruation ends (Cycles 0, 1, and 2). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively. | Quality of life impact will be evaluated through 3 individual items assessing the degree to which symptoms interfere with work/school participation, relationships, and enjoyment of life, using a 5-point frequency scale (Never, Rarely, Sometimes, Often, Always). Individual item scores will be analyzed separately. |
| Secondary | Change in premenstrual physical symptom NRS from Cycle 0 to Cycle 1 and Cycle 2. | Retroactively at Day 1 of Cycle 1 and 2, covering the preceding 14-day premenstrual phase. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively. | Physical symptom severity during the premenstrual phase will be assessed through 5 individual items evaluating bloating, nausea, breast tenderness, headaches, and muscle/bone/joint pain. Responses will be recorded on a Numeric Rating Scale (NRS; 0 = none, 10 = worst possible severity). Scores will be analyzed on a per-item basis. |
| Secondary | Change in premenstrual psychological symptom NRS from Cycle 0 to Cycle 1 and Cycle 2. | Retroactively at Day 1 of Cycle 1 and 2, covering the preceding 14-day premenstrual phase. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively. | Psychological symptom severity during the premenstrual phase will be assessed through 8 individual items evaluating mood swings, anger/irritability, sadness/low mood, anxiety/tension, feeling overwhelmed/unable to cope, difficulty concentrating, fatigue/low energy, and changes in appetite (overeating/food cravings). Responses will be recorded on a Numeric Rating Scale (NRS; 0 = none, 10 = worst possible severity). Scores will be analyzed on a per-item basis. |
| Secondary | Change in premenstrual quality of life impact from Cycle 0 to Cycle 1 and Cycle 2. | Retroactively at Day 1 of Cycle 1 and 2, covering the preceding 14-day premenstrual phase. Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively. | Quality of life impact will be evaluated through 3 individual items assessing the degree to which symptoms interfere with work/school participation, relationships, and enjoyment of life, using a 5-point frequency scale (Never, Rarely, Sometimes, Often, Always). Individual item scores will be analyzed separately. |
| Secondary | Patient global impression of change (PGIC). | Once at the end of the study (the day after the last day of menstruation in Cycle 2). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively. | The Patient Global Impression of Change (PGIC) is a single-item measure on which participants rate their overall change in menstrual symptoms since the start of the study on a 7-point scale ranging from "very much worse" to "very much improved." |
| Secondary | Participant's Consumer Experience. | Once at the end of the study (the day after the last day of menstruation in Cycle 2). Cycle length and menstruation duration are participant- and cycle-dependent, ranging from 21-35 d and 3-7 d, respectively. | Participants complete a purpose-built questionnaire covering 4 domains: overall product satisfaction, perceived benefit, recommendation likelihood, and blinding perception. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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