Primary DysmenorrheaPhase 2/3NCT03323671
Preemptive Analgesia for Primary Dysmenorrhoea
A Phase 2/3 study testing preemptive mefenamic acid and mefenamic acid in people with Primary Dysmenorrhea, run by Hanan Nabil at 1 site in Egypt.
Trial summary
Preemptive analgesia before the release of pain mediators Read more about this study
- Who is it for?
- Ages 15 to 25 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- preemptive mefenamic acid and mefenamic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2017to 1 Dec 2017
- Phase
- Phase 2/3
- 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 15 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- nulliparous ladies
- with regular menstrual cycle pattern
- those experienced history of dysmenorrhea (primary or spasmodic)
- patients able to sallow tables
Who cannot join
- irregular cycles
- any associated local causes( pelvic infection, endometriosis, fibroid or others)
- patients with familial Mediterranean fever or other intermenstrual attacks of abdominal pain
- gastric or duodenal ulcers or gastritis
- other contraindications to non steroidal anti-inflammatory drugs
- patients with severe diminution of vision or color discrimination
- patients with any depressive or mood disorders
- patients receiving any hormonal treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preemptive Analgesia for Primary Dysmenorrhoea: a Randomized Controlled Trial
Preemptive analgesia before the release of pain mediators
Read the detailed description
spasmodic dysmenorrhea is one of the most distressing symptoms in women. adolescents shows a usual absence from school . prostaglandin release is one of the most accepted theory responsible for spasmodic dysmenorrhea.
Non steroidal anti inflammatory Drugs were proved to be one of the alternative medications for spasmodic dysmenorrhea.
Getting the idea of what is called preemptive anesthesia by blocking the receptors before catching pain mediators the study participants will be divided randomly into 2 group group 1 receiving ttt 2 days before the anticipated menstruation and group 2 receiving ttt only during menstruation as analgesia
- Conditions
- Primary Dysmenorrhea
- Being tested
- preemptive mefenamic acid, mefenamic acid
- Keywords
- primary dysmenorrhea, preemptive analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preemptive mefenamic acidDrug
Also called ponstan forte
preemptive analgesia before menstrual pain
mefenamic acidDrug
Also called ponstan forte
mefenamic acid given only during menstruation
| Study group | Role | What they receive |
|---|---|---|
| premenstruation group | Experimental | preemptive mefenamic acid 500mg tablets every 8 hours starting 2 days before anticipated menstruation and during the first 2 days of the cycle Receives: Drug: preemptive mefenamic acid |
| menstruation group | Experimental | mefenamic acid 500mg tablets every 8 hours during the first 2 days of the cycle Receives: Drug: mefenamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the Degree of pain
severity of pain according to visual pain analog scale
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Aug 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanan Nabil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hanan Nabil, Mansoura University
- Investigators
- Hanan Nabil, MD, Principal investigator, Manoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323671
- Sponsor's protocol ID
- 27011975
- Status last verified
- Dec 2017
- First submitted
- 27 Oct 2015
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Analgesia for Primary Dysmenorrhoea: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03323671
- Acronym / sponsor ID
- 27011975
- Conditions
- Primary Dysmenorrhea
- Keywords
- primary dysmenorrhea, preemptive analgesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hanan NabilUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 27 Oct 2017 (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.
Preemptive analgesia before the release of pain mediators
Detailed description
spasmodic dysmenorrhea is one of the most distressing symptoms in women. adolescents shows a usual absence from school . prostaglandin release is one of the most accepted theory responsible for spasmodic dysmenorrhea.
Non steroidal anti inflammatory Drugs were proved to be one of the alternative medications for spasmodic dysmenorrhea.
Getting the idea of what is called preemptive anesthesia by blocking the receptors before catching pain mediators the study participants will be divided randomly into 2 group group 1 receiving ttt 2 days before the anticipated menstruation and group 2 receiving ttt only during menstruation as analgesia
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| premenstruation group | Experimental | Drug: preemptive mefenamic acidpreemptive mefenamic acid 500mg tablets every 8 hours starting 2 days before anticipated menstruation and during the first 2 days of the cycle |
| menstruation group | Experimental | Drug: mefenamic acidmefenamic acid 500mg tablets every 8 hours during the first 2 days of the cycle |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- nulliparous ladies
- with regular menstrual cycle pattern
- those experienced history of dysmenorrhea (primary or spasmodic)
- patients able to sallow tables
Key exclusion criteria (8 listed)
- irregular cycles
- any associated local causes( pelvic infection, endometriosis, fibroid or others)
- patients with familial Mediterranean fever or other intermenstrual attacks of abdominal pain
- gastric or duodenal ulcers or gastritis
- other contraindications to non steroidal anti-inflammatory drugs
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 |
|---|---|---|
| preemptive mefenamic acidAlso: ponstan fortepreemptive analgesia before menstrual pain | Drug | premenstruation group |
| mefenamic acidAlso: ponstan fortemefenamic acid given only during menstruation | Drug | menstruation group |
Primary outcome
change in the Degree of pain
Time frame: 4 months
severity of pain according to visual pain analog scale
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 19 Dec 2017.
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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.
Hanan Nabil, MD principal investigator
Manoura University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing preemptive mefenamic acid and mefenamic acid in people with Primary Dysmenorrhea, run by Hanan Nabil at 1 site in Egypt.
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 4 inclusion and 8 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 19 Dec 2017. 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 Egypt. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
change in the Degree of pain (time frame: 4 months). 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 19 Dec 2017.