A Phase 3 interventional study of Dexketoprofen / Butylscopolamine in fixed dose combination tablet. (Laboratorios Silanes S.A. de C.V.) and 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.) in Primary Dysmenorrhea, sponsored by Laboratorios Silanes S.A. de C.V.. Completed at 4 sites in Mexico. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Laboratorios Silanes S.A. de C.V. · Phase 3, Interventional, and Treatment
This study seeks to evaluate the efficacy and safety of the fixed dose combination of dexketoprofen/butylscopolamine compared to dexketoprofen for the treatment of primary dysmenorrhea in 130 mexican women.
The primary efficacy endpoint of this study was the assessment of intervention efficacy regarding pain intensity-measured via visual analogue scale (VAS) at 30 minutes and at 1, 2, 4, 6, 8, 24, 48, and 72 hours-to determine whether treatment with dexketoprofen/butylscopolamine resulted in a greater reduction in pain than dexketoprofen monotherapy. The primary safety endpoint involved describing, classifying, and comparing adverse events occurring during the study across treatment arms, based on their gravity, frequency, severity, and causality.
430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.
This study's enrollment of 130 is above the median of 62 across 363 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →Laboratorios Silanes S.A. de C.V. is the lead sponsor of 45 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group A: Dexketoprofen / Butylscopolamine in fixed dose combination. Pharmaceutical form: Tablet. Each tablet contains: * Dexketoprofen: 25 mg * Butylscopolamine: 10 mg Administration way: Oral
Drug: Dexketoprofen / Butylscopolamine in fixed dose combination tablet. (Laboratorios Silanes S.A. de C.V.)
Group B: Dexketoprofen Pharmaceutical form: Tablet. Each tablet contains: -Dexketoprofen 25 mg Administration way: Oral
Drug: 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.)
Formula: 25 mg / 10 mg Pharmaceutical Form: Tablet Dosage: 1 tablet (25 mg / 10 mg) Aministration way: Oral
Drug page: Dexketoprofen
Pharmaceutical form: Tablet Formula: 25 mg Dosage: 1 tablet of 25 mg Administration way: Oral
To evaluate the efficacy of the fixed-dose combination of dexketoprofen/butylscopolamine compared with dexketoprofen monotherapy in reducing pain intensity associated with primary dysmenorrhea.
-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.
Time frame: Baseline, 0.5, 1, 2, 4, 6, 8, 24, 48 and 72 hours.
To evaluate the safety of the fixed-dose combination of dexketoprofen/butylscopolamine compared with dexketoprofen monotherapy in reducing pain intensity associated with primary dysmenorrhea.
-Description, classification, and comparison of adverse events occurring during the study across treatment arms, based on their gravity, frequency, severity, and causality.
Time frame: Baseline, 0.5, 1, 2, 4, 6, 8, 24, 48 and 72 hours.
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.
-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.
Time frame: Baseline, 0.5, 1, 2, 4, 6, 8, 24, 48 and 72 hours.
To evaluate the improvement in symptoms with the fixed-dose combination of dexketoprofen/butylscopolamine compared to dexketoprofen for the treatment of primary dysmenorrhea.
-Improvement in symptomatology based on the change in Moos Distress Questionnaire (MDQ) scores from baseline to the end of treatment, by treatment group.
Time frame: Baseline, 0.5, 1, 2, 4, 6, 8, 24, 48 and 72 hours.
To evaluate the quality of life with the fixed-dose combination of dexketoprofen/butylscopolamine compared to dexketoprofen for the treatment of primary dysmenorrhea.
-Change in EQ-5D-3L scores from baseline to the end of treatment, by treatment group.
Time frame: Baseline, 0.5, 1, 2, 4, 6, 8, 24, 48 and 72 hours.
Exploratory Outcomes
-Describe the proportion of subjects requiring the use of rescue medication during the study across treatment groups.
Time frame: Baseline and 72 hours
Exploratory Outcomes
-Describe the percentage of therapeutic adherence at the end of the intervention by treatment group.
Time frame: Baseline and 72 hours
Plan to share: No — For reasons of personal data protection
No publications or documents are linked to this record.
Ran from Jul 2025 to primary completion in May 2026, 10 months.
Of 17 phase 3 interventional studies under Dysmenorrhea, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 30. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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