Trial · NCT07901894
Study to Evaluate the Efficacy and Safety of Dexketoprofen / Butylscopolamine vs Dexketoprofen in Treatment of Primary Dysmenorrhea
NCT07901894, Phase 3, Completed, Laboratorios Silanes S.A. de C.V.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Efficacy and Safety of Dexketoprofen / Butylscopolamine vs Dexketoprofen in Treatment of Primary Dysmenorrhea. Trials, record NCT07901894. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07901894
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of Dexketoprofen / Butylscopolamine vs Dexketoprofen in Treatment of Primary Dysmenorrhea
- NCT number
- NCT07901894
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 130 participants, actual
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.
- Conditions
- Primary Dysmenorrhea
- Interventions
Dexketoprofen / Butylscopolamine in fixed dose combination tablet. (Laboratorios Silanes S.A. de C.V.), Dexketoprofen (Stadium®, Menarini Manufacturing Logistics and Services S.R.L. Conditioned by Grimann, S.A. de C.V. Distributed by: Sanfer Laboratories S.A. de C.V.)
- First posted
- 2026-10-28
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To evaluate the efficacy of the fixed-dose combination of dexketoprofen/butylscopolamine compared with dexketoprofen monotherapy in reducing pain intensity associated with primary dysmenorrhea. | Baseline, 0.5, 1, 2, 4, 6, 8, 24, 48 and 72 hours. | -Mean pain intensity scores obtained via visual analogue scale at 0.5, 1, 2, 4, 6, 8, 24, 48, and 72 hours, in order to determine whether treatment with dexketoprofen/butylscopolamine results in a greater reduction in pain than treatment with dexketoprofen monotherapy. |
| Primary | To evaluate the safety of the fixed-dose combination of dexketoprofen/butylscopolamine compared with dexketoprofen monotherapy in reducing pain intensity associated with primary dysmenorrhea. | Baseline, 0.5, 1, 2, 4, 6, 8, 24, 48 and 72 hours. | -Description, classification, and comparison of adverse events occurring during the study across treatment arms, based on their gravity, frequency, severity, and causality. |
| Secondary | To evaluate the magnitude of change in pain intensity with the fixed-dose combination of dexketoprofen/butylscopolamine compared to dexketoprofen for the treatment of primary dysmenorrhea. | Baseline, 0.5, 1, 2, 4, 6, 8, 24, 48 and 72 hours. | -Magnitude of change in pain intensity, measured using a Visual Analogue Scale (VAS: 0-100) at 0.5, 1, 2, 4, 6, 8, 24, 48, and 72 hours of treatment, relative to the baseline score for each treatment group. |
| Secondary | To evaluate the improvement in symptoms with the fixed-dose combination of dexketoprofen/butylscopolamine compared to dexketoprofen for the treatment of primary dysmenorrhea. | Baseline, 0.5, 1, 2, 4, 6, 8, 24, 48 and 72 hours. | -Improvement in symptomatology based on the change in Moos Distress Questionnaire (MDQ) scores from baseline to the end of treatment, by treatment group. |
| Secondary | To evaluate the quality of life with the fixed-dose combination of dexketoprofen/butylscopolamine compared to dexketoprofen for the treatment of primary dysmenorrhea. | Baseline, 0.5, 1, 2, 4, 6, 8, 24, 48 and 72 hours. | -Change in EQ-5D-3L scores from baseline to the end of treatment, by treatment group. |
| Other | Exploratory Outcomes | Baseline and 72 hours | -Describe the proportion of subjects requiring the use of rescue medication during the study across treatment groups. |
| Other | Exploratory Outcomes | Baseline and 72 hours | -Describe the percentage of therapeutic adherence at the end of the intervention by treatment group. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07901894
GET https://conductscience.org/api/trials/v1/NCT07901894/registered