DysmenorrheaIVMAGNCT07248540
IV Magnesium in the Treatment of Acute Dysmenorrhea
A study testing Magnesium Sulfate (2 Ampoules) and Dexketoprofen in people with Dysmenorrhea, run by Havva Betül Bacak at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, double-blind clinical trial aims to evaluate the analgesic efficacy of intravenous magnesium sulfate in women presenting to the emergency department with acute dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Magnesium Sulfate (2 Ampoules) and Dexketoprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 patients aged 18 to 35 years
- Presenting to the obstetrics and gynecology emergency department with a diagnosis of primary dysmenorrhea
- Having regular menstrual cycles within the last 6 months
- Having a Visual Analog Scale (VAS) pain score of ≥6 at emergency admission
- Providing written informed consent for participation in the study
Who cannot join
- Patients with secondary dysmenorrhea or underlying gynecological pathology
- Pregnancy or breastfeeding
- Use of analgesics or muscle relaxants within the last 3 days
- Known allergy to magnesium sulfate or dexketoprofen trometamol
- History of renal failure, cardiac arrhythmia, or serious systemic disease
- Inability to assess pain due to mental disability or communication disorder
- Failure to provide informed consent for participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
SBÜ Gaziosmanpaşa Training and Research Hospital
Gaziosmanpaşa, Outside of the US, 33400
yağmur acıyiyen, md, +9005425669593, yagmuraciyiyen95@gmail.com
ecenur çelikoğlu, md, +90 538 54 92 848, ecenurcelikoglu14@gmail.com
About this study
Official title: Evaluation of Intravenous Magnesium Administration in the Treatment of Dysmenorrhea
This prospective, randomized, double-blind clinical trial aims to evaluate the analgesic efficacy of intravenous magnesium sulfate in women presenting to the emergency department with acute dysmenorrhea. Participants will be randomized into two groups receiving either 2 ampoules of magnesium sulfate or intravenous dexketoprofen. Pain levels will be assessed using the Visual Analog Scale (VAS) before and after treatment.
Read the detailed description
This prospective, randomized, double-blind clinical trial is designed to evaluate the analgesic effectiveness of intravenous magnesium sulfate in women aged 18 to 35 years presenting to the emergency department with acute dysmenorrhea. Participants will be randomly assigned to one of two treatment groups: 2 ampoules of magnesium sulfate or intravenous dexketoprofen.
All medications will be diluted in 100 ml of normal saline and administered intravenously over 15 minutes. Pain intensity will be assessed using the Visual Analog Scale (VAS) before treatment and 1 hour after administration. Secondary outcomes include patient satisfaction, vital sign changes, and adverse effects.
The study aims to compare the analgesic efficacy and safety profile of intravenous magnesium sulfate with that of a standard nonsteroidal anti-inflammatory drug (dexketoprofen) in the management of acute dysmenorrhea.
- Conditions
- Dysmenorrhea
- Being tested
- Magnesium Sulfate (2 Ampoules), Dexketoprofen
- Keywords
- Dysmenorrhea, Magnesium Therapy, Pain Management
- Medical subject headings
- Dysmenorrhea, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulfate (2 Ampoules)Drug
Intravenous administration of 2 ampoules (8 ml total) of magnesium sulfate diluted in 100 ml normal saline, infused over 15 minutes.
DexketoprofenDrug
Intravenous administration of 50 mg dexketoprofen diluted in 100 ml normal saline, infused over 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Sulfate 2 Ampoules | Experimental | Participants receive 2 ampoules (8 ml total) of intravenous magnesium sulfate diluted in 100 ml normal saline, administered over 15 minutes. Receives: Drug: Magnesium Sulfate (2 Ampoules) |
| Intravenous Dexketoprofen | Active comparator | Participants receive 50 mg of intravenous dexketoprofen diluted in 100 ml normal saline, administered over 15 minutes. Receives: Drug: Dexketoprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity measured by Visual Analog Scale (VAS)
Pain severity will be assessed using the 0-10 Visual Analog Scale (VAS) before treatment and 1 hour post-treatment. The study will evaluate and compare the analgesic effect of two different doses of intravenous magnesium sulfate (2 ampoules vs. 3 ampoules) and compare both to intravenous dexketoprofen in women presenting with acute dysmenorrhea.
Measured: Baseline and 1 hour after intravenous treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Jul 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, double-blind, parallel assignment clinical trial where participants are allocated into two groups to receive different intravenous treatments: 2 ampoules of magnesium sulfate or intravenous dexketoprofen. Each treatment is administered over 15 minutes, and pain outcomes are compared between groups.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Havva Betül Bacak
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Havva Betül Bacak, Gaziosmanpasa Research and Education Hospital
- Investigators
- havva betül bacak, md, Principal investigator, SBÜ Gaziosmanpaşa Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248540
- Sponsor's protocol ID
- GOP-IVMAG-DYSMENORRHEA
- Acronym
- IVMAG
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intravenous Magnesium Administration in the Treatment of Dysmenorrhea
- ClinicalTrials.gov ID
- NCT07248540
- Acronym / sponsor ID
- IVMAG / GOP-IVMAG-DYSMENORRHEA
- Conditions
- Dysmenorrhea
- Keywords
- Dysmenorrhea, Magnesium Therapy, Pain Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Havva Betül BacakOther government
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 25 Nov 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.
This prospective, randomized, double-blind clinical trial aims to evaluate the analgesic efficacy of intravenous magnesium sulfate in women presenting to the emergency department with acute dysmenorrhea. Participants will be randomized into two groups receiving either 2 ampoules of magnesium sulfate or intravenous dexketoprofen. Pain levels will be assessed using the Visual Analog Scale (VAS) before and after treatment.
Detailed description
This prospective, randomized, double-blind clinical trial is designed to evaluate the analgesic effectiveness of intravenous magnesium sulfate in women aged 18 to 35 years presenting to the emergency department with acute dysmenorrhea. Participants will be randomly assigned to one of two treatment groups: 2 ampoules of magnesium sulfate or intravenous dexketoprofen.
All medications will be diluted in 100 ml of normal saline and administered intravenously over 15 minutes. Pain intensity will be assessed using the Visual Analog Scale (VAS) before treatment and 1 hour after administration. Secondary outcomes include patient satisfaction, vital sign changes, and adverse effects.
The study aims to compare the analgesic efficacy and safety profile of intravenous magnesium sulfate with that of a standard nonsteroidal anti-inflammatory drug (dexketoprofen) in the management of acute dysmenorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, double-blind, parallel assignment clinical trial where participants are allocated into two groups to receive different intravenous treatments: 2 ampoules of magnesium sulfate or intravenous dexketoprofen. Each treatment is administered over 15 minutes, and pain outcomes are compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Magnesium Sulfate 2 Ampoules | Experimental | Drug: Magnesium Sulfate (2 Ampoules)Participants receive 2 ampoules (8 ml total) of intravenous magnesium sulfate diluted in 100 ml normal saline, administered over 15 minutes. |
| Intravenous Dexketoprofen | Active comparator | Drug: DexketoprofenParticipants receive 50 mg of intravenous dexketoprofen diluted in 100 ml normal saline, administered over 15 minutes. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female patients aged 18 to 35 years
- Presenting to the obstetrics and gynecology emergency department with a diagnosis of primary dysmenorrhea
- Having regular menstrual cycles within the last 6 months
- Having a Visual Analog Scale (VAS) pain score of ≥6 at emergency admission
- Providing written informed consent for participation in the study
Key exclusion criteria (7 listed)
- Patients with secondary dysmenorrhea or underlying gynecological pathology
- Pregnancy or breastfeeding
- Use of analgesics or muscle relaxants within the last 3 days
- Known allergy to magnesium sulfate or dexketoprofen trometamol
- History of renal failure, cardiac arrhythmia, or serious systemic disease
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 |
|---|---|---|
| Magnesium Sulfate (2 Ampoules)Intravenous administration of 2 ampoules (8 ml total) of magnesium sulfate diluted in 100 ml normal saline, infused over 15 minutes. | Drug | Magnesium Sulfate 2 Ampoules |
| DexketoprofenIntravenous administration of 50 mg dexketoprofen diluted in 100 ml normal saline, infused over 15 minutes. | Drug | Intravenous Dexketoprofen |
Primary outcome
Change in pain intensity measured by Visual Analog Scale (VAS)
Time frame: Baseline and 1 hour after intravenous treatment
Pain severity will be assessed using the 0-10 Visual Analog Scale (VAS) before treatment and 1 hour post-treatment. The study will evaluate and compare the analgesic effect of two different doses of intravenous magnesium sulfate (2 ampoules vs. 3 ampoules) and compare both to intravenous dexketoprofen in women presenting with acute dysmenorrhea.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- 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.
havva betül bacak, md principal investigator
SBÜ Gaziosmanpaşa Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Sulfate (2 Ampoules) and Dexketoprofen in people with Dysmenorrhea, run by Havva Betül Bacak 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 7 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: looking for participants now, as of the sponsor's last update on 25 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ecenur çelikoğlu, md (+90 538 54 92 848, ecenurcelikoglu14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity measured by Visual Analog Scale (VAS) (time frame: Baseline and 1 hour after intravenous treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2025.