Primary DysmenorrheaPhase 3NCT07901894

Study to Evaluate the Efficacy and Safety of Dexketoprofen / Butylscopolamine vs Dexketoprofen in Treatment of Primary Dysmenorrhea

A Phase 3 study testing 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 people with Primary Dysmenorrhea, run by Laboratorios Silanes S.A. de C.V. at 4 sites in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 35 years, women only
Conditions the study is for: Primary Dysmenorrhea
What is being tested?: 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.)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 4 sitesMexico
Study dates: 2 Jul 2025to 7 May 2026
Phase: Phase 3
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

Female, 18 to 35 years of age.
Agrees to participate in the study by signing the Informed Consent Form.
History of a diagnosis of primary dysmenorrhea, characterized as colicky lower abdominal pain during menstruation, present for at least 3 consecutive menstrual cycles, lasting between 4 hours and 4 days, not associated with underlying pathology, and with onset before the age of 18.
Presence of regular menstrual cycles (in accordance with international guidelines and consensus, a regular menstrual cycle is defined as one lasting between 21 and 35 days, with bleeding usually lasting between 2 and 7 days) during the 6 months prior to study enrollment, as reported by the patient during direct questioning.
History of pain secondary to dysmenorrhea with an intensity of ≥50 mm on the Visual Analog Scale during the 3 menstrual cycles prior to study enrollment, as reported by the patient during direct questioning.
Willing and able to comply with scheduled visits and the study treatment plan, as confirmed by the patient during direct questioning.
In the opinion of the Principal Investigator or treating physician, is indicated for treatment with the investigational product and is likely to derive clinical benefit.
Agrees to use one of the following barrier methods: diaphragm, cervical cap, male condom, female condom, foam, sponge, or spermicidal film.

Who cannot join

Patients participating in another clinical trial involving an investigational treatment, or who have participated in one within the 2 weeks prior to the start of the study.
Patients whose participation in the study could be influenced (employment relationship with the research center or sponsor, vulnerable populations, etc.).
At the physician's discretion, a disease affecting prognosis and preventing outpatient management; this must be evaluated by the principal investigator to determine the appropriateness of the subject's inclusion in the study.
History of a diagnosis of secondary dysmenorrhea (determined via direct questioning of the patient or transvaginal/pelvic ultrasound performed within the last 3 months).
Allergy or hypersensitivity to the study medications or any of their excipients (dexketoprofen and butylscopolamine).
History of bronchospasm, rhinitis, asthma, urticaria, or edema associated with the use of aspirin or any NSAID.

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Medical or surgical history suggesting the presence of endometriosis, uterine fibroids (myomatosis), ovarian cysts, adenomyosis, or polycystic ovary syndrome, as well as sexually transmitted diseases and/or pelvic inflammatory disease.
Current or recent use of medications that could affect pain scores, such as hormonal contraceptives (within the previous 3 months) or other NSAIDs (within the previous 72 hours).
History of chronic dyspepsia, peptic ulcer, gastrointestinal bleeding, Crohn's disease, ulcerative colitis, etc.
Pregnancy, breastfeeding, or the postpartum period (less than 6 months).
Current or recent use (within the previous 3 months) of antidepressants or anxiolytics.
Use of a copper intrauterine device (IUD).
History of occasional excessive alcohol consumption (more than 4 standard drinks per day for women) and drug use.

Trial locations and contacts

4 sites in 1 country.

Mexico4 sites

Unidad Clínica de Bioequivalencia S. de R.L. de C.V.
Guadalajara, Jalisco, 44190
Medical Care and Research S.A. de C.V.
Mérida, Yucatán, 97070
CICMEX Centro de Investigación Clínica de México S. de R.L. de C.V.
Morelia, Michoacán, 58000
Clinical Research Institute S.C.
Tlalnepantla, State of Mexico, 54055

Other trials in Mexico

About this study

Official title: A Phase III, Parallel-group Study to Evaluate the Efficacy and Safety of the Fixed-dose Combination of Dexketoprofen/Butylscopolamine Compared With Dexketoprofen Monotherapy in the Treatment of Primary Dysmenorrhea

Read the detailed description

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.

Conditions: Primary Dysmenorrhea
Being tested: 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.)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dexketoprofen / Butylscopolamine in fixed dose combination tablet. (Laboratorios Silanes S.A. de C.V.)Drug
Formula: 25 mg / 10 mg Pharmaceutical Form: Tablet Dosage: 1 tablet (25 mg / 10 mg) Aministration way: Oral
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.)Drug
Pharmaceutical form: Tablet Formula: 25 mg Dosage: 1 tablet of 25 mg Administration way: Oral

Study groups in NCT07901894
Study group	Role	What they receive
Dexketoprofen / Butylscopolamine	Experimental	Group A: Dexketoprofen / Butylscopolamine in fixed dose combination. Pharmaceutical form: Tablet. Each tablet contains: * Dexketoprofen: 25 mg * Butylscopolamine: 10 mg Administration way: Oral Receives: Drug: Dexketoprofen / Butylscopolamine in fixed dose combination tablet. (Laboratorios Silanes S.A. de C.V.)
Dexketoprofen	Active comparator	Group B: Dexketoprofen Pharmaceutical form: Tablet. Each tablet contains: -Dexketoprofen 25 mg Administration way: Oral Receives: 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.)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline, 0.5, 1, 2, 4, 6, 8, 24, 48 and 72 hours.

Secondary outcomes (3)

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.
Measured: 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.
Measured: 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.
Measured: Baseline, 0.5, 1, 2, 4, 6, 8, 24, 48 and 72 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jul 20257 May 2026

First posted28 Oct 2026
Study start2 Jul 2025
Primary completion7 May 2026
Study completion7 May 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07901894
Sponsor's protocol ID: SIL-30246-III-24(1)
Status last verified: Oct 2026
First submitted: 14 Oct 2026
Last updated: 28 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: For reasons of personal data protection

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Primary Dysmenorrhea trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Parallel-group Study to Evaluate the Efficacy and Safety of the Fixed-dose Combination of Dexketoprofen/Butylscopolamine Compared With Dexketoprofen Monotherapy in the Treatment of Primary Dysmenorrhea
ClinicalTrials.gov ID: NCT07901894
Acronym / sponsor ID: SIL-30246-III-24(1)
Conditions: Primary Dysmenorrhea
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
Study start: 2 Jul 2025 (actual)
Primary completion: 7 May 2026 (actual)
Study completion: 7 May 2026 (actual)
First posted: 28 Oct 2026 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Dexketoprofen / Butylscopolamine	Experimental	Drug: Dexketoprofen / Butylscopolamine in fixed dose combination tablet. (Laboratorios Silanes S.A. de C.V.)Group A: Dexketoprofen / Butylscopolamine in fixed dose combination. Pharmaceutical form: Tablet. Each tablet contains: * Dexketoprofen: 25 mg * Butylscopolamine: 10 mg Administration way: Oral
Dexketoprofen	Active comparator	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.)Group B: Dexketoprofen Pharmaceutical form: Tablet. Each tablet contains: -Dexketoprofen 25 mg Administration way: Oral

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Female, 18 to 35 years of age.
Agrees to participate in the study by signing the Informed Consent Form.
History of a diagnosis of primary dysmenorrhea, characterized as colicky lower abdominal pain during menstruation, present for at least 3 consecutive menstrual cycles, lasting between 4 hours and 4 days, not associated with underlying pathology, and with onset before the age of 18.
Presence of regular menstrual cycles (in accordance with international guidelines and consensus, a regular menstrual cycle is defined as one lasting between 21 and 35 days, with bleeding usually lasting between 2 and 7 days) during the 6 months prior to study enrollment, as reported by the patient during direct questioning.
History of pain secondary to dysmenorrhea with an intensity of ≥50 mm on the Visual Analog Scale during the 3 menstrual cycles prior to study enrollment, as reported by the patient during direct questioning.

Key exclusion criteria (13 listed)

Patients participating in another clinical trial involving an investigational treatment, or who have participated in one within the 2 weeks prior to the start of the study.
Patients whose participation in the study could be influenced (employment relationship with the research center or sponsor, vulnerable populations, etc.).
At the physician's discretion, a disease affecting prognosis and preventing outpatient management; this must be evaluated by the principal investigator to determine the appropriateness of the subject's inclusion in the study.
History of a diagnosis of secondary dysmenorrhea (determined via direct questioning of the patient or transvaginal/pelvic ultrasound performed within the last 3 months).
Allergy or hypersensitivity to the study medications or any of their excipients (dexketoprofen and butylscopolamine).

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
Dexketoprofen / Butylscopolamine in fixed dose combination tablet. (Laboratorios Silanes S.A. de C.V.)Formula: 25 mg / 10 mg Pharmaceutical Form: Tablet Dosage: 1 tablet (25 mg / 10 mg) Aministration way: Oral	Drug	Dexketoprofen / Butylscopolamine
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.)Pharmaceutical form: Tablet Formula: 25 mg Dosage: 1 tablet of 25 mg Administration way: Oral	Drug	Dexketoprofen

Primary outcome

To evaluate the efficacy of the fixed-dose combination of dexketoprofen/butylscopolamine compared with dexketoprofen monotherapy in reducing pain intensity associated with primary dysmenorrhea.
Time frame: 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.
To evaluate the safety of the fixed-dose combination of dexketoprofen/butylscopolamine compared with dexketoprofen monotherapy in reducing pain intensity associated with primary dysmenorrhea.
Time frame: 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.

3 secondary outcomes

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.
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.
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.
Time frame: Baseline, 0.5, 1, 2, 4, 6, 8, 24, 48 and 72 hours.

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 28 Oct 2026.
Individual participant dataSharing planned: No. For reasons of personal data protection

Related trials for Primary Dysmenorrhea

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Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
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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.

Luis Eladio Sánchez-De Jesús, Dr. principal investigator

CICMEX Centro de Investigación Clínica de México S. de R.L. de C.V.

Fernando de Jesús Hernández-Rangel-Muñoz, Dr. principal investigator

Unidad Clínica de Bioequivalencia S. de R.L. de C.V.

Félix Martínez-Moreno, Dr. principal investigator

Clinical Research Institute S.C.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 13 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Mexico. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

To evaluate the efficacy of the fixed-dose combination of dexketoprofen/butylscopolamine compared with dexketoprofen monotherapy in reducing pain intensity associated with primary dysmenorrhea. (time frame: Baseline, 0.5, 1, 2, 4, 6, 8, 24, 48 and 72 hours.). 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 NCT07901894.

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 28 Oct 2026.