ContraceptionPhase 2NCT02580344
The Effect of Ibuprofen on Intrauterine Contraceptive Device Associated Uterine Bleeding
A Phase 2 study testing Ibuprofen in people with Contraception, run by Assiut University at 1 site in Egypt.
Trial summary
The Copper intrauterine device is the most common method of reversible contraception worldwide. Abnormal uterine bleeding and pain are the most common medical indications for the discontinuation of the intrauterine device. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2015to Nov 2016
- Phase
- Phase 2
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women have menorrhagia secondary to IUD.
- Planning for birth spacing for at least 1 year.
- Patient aged between 20-45 years old.
- No history of any medical treatment.
- Living in a nearby area to make follow-up reasonably possible.
Who cannot join
- Evidence of defective coagulation.
- History or evidence of malignancy.
- Hyperplasia in the endometrial biopsy.
- Incidental adnexal abnormality on ultrasound.
- Untreated abnormal cervical cytology
- contraindications to ibuprofen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Action of Ibuprofen on IUD-associated Heavy Menstrual Bleeding
The Copper intrauterine device is the most common method of reversible contraception worldwide. Abnormal uterine bleeding and pain are the most common medical indications for the discontinuation of the intrauterine device.
Excessive prostaglandin release in the endometrial cavity appears to play an important role in both bleeding and pain related to copper intrauterine devices.There are many types of prostaglandin metabolites that present in the endometrium one of them is prostacyclin which causes vasodilatation and inhibits platelet aggregation. Another one is thromboxane which has two types; A2 which is active and rapidly converted into B2, which is inactive. Thromboxane causes vasoconstriction and blood clotting.
Read more
Non-steroidal anti-inflammatory drugs (NSAIDs) are prostaglandin synthetase inhibitors acting by decreasing production of endometrial prostaglandins; they can improve both heavy uterine bleeding and pain. Since its discovery; several drugs in NSAIDs class have been used to treat heavy uterine bleeding and pain associated with copper intrauterine device use such as mefenamic acid, ibuprofen and naproxen.
The most recent systematic review found NSAIDs is the most widely studied drugs for reduction of the menstrual blood and pain associated with copper intrauterine device. The Cochrane Review also found that NSAIDs are the most effective treatment to reduce the bleeding with copper intrauterine device use.
- Conditions
- Contraception
- Being tested
- Ibuprofen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
The women will receive 400mg ibuprofen 3 times per day from the first day of the cycle for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Other | Not described Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bleeding days per month
by menstrual diary
Measured: 3 months
Secondary outcomes (1)
Uterine Doppler indices
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580344
- Sponsor's protocol ID
- IUD_Ibuprofen
- Status last verified
- Mar 2017
- First submitted
- 18 Oct 2015
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Action of Ibuprofen on IUD-associated Heavy Menstrual Bleeding
- ClinicalTrials.gov ID
- NCT02580344
- Acronym / sponsor ID
- IUD_Ibuprofen
- Conditions
- Contraception
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 20 Oct 2015 (estimated)
- 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.
The Copper intrauterine device is the most common method of reversible contraception worldwide. Abnormal uterine bleeding and pain are the most common medical indications for the discontinuation of the intrauterine device.
Excessive prostaglandin release in the endometrial cavity appears to play an important role in both bleeding and pain related to copper intrauterine devices.There are many types of prostaglandin metabolites that present in the endometrium one of them is prostacyclin which causes vasodilatation and inhibits platelet aggregation. Another one is thromboxane which has two types; A2 which is active and rapidly converted into B2, which is inactive. Thromboxane causes vasoconstriction and blood clotting.
Non-steroidal anti-inflammatory drugs (NSAIDs) are prostaglandin synthetase inhibitors acting by decreasing production of endometrial prostaglandins; they can improve both heavy uterine bleeding and pain. Since its discovery; several drugs in NSAIDs class have been used to treat heavy uterine bleeding and pain associated with copper intrauterine device use such as mefenamic acid, ibuprofen and naproxen.
The most recent systematic review found NSAIDs is the most widely studied drugs for reduction of the menstrual blood and pain associated with copper intrauterine device. The Cochrane Review also found that NSAIDs are the most effective treatment to reduce the bleeding with copper intrauterine device use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Other | Drug: Ibuprofen |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women have menorrhagia secondary to IUD.
- Planning for birth spacing for at least 1 year.
- Patient aged between 20-45 years old.
- No history of any medical treatment.
- Living in a nearby area to make follow-up reasonably possible.
Key exclusion criteria (6 listed)
- Evidence of defective coagulation.
- History or evidence of malignancy.
- Hyperplasia in the endometrial biopsy.
- Incidental adnexal abnormality on ultrasound.
- Untreated abnormal cervical cytology
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 |
|---|---|---|
| IbuprofenThe women will receive 400mg ibuprofen 3 times per day from the first day of the cycle for 5 days | Drug | Ibuprofen |
Primary outcome
Number of bleeding days per month
Time frame: 3 months
by menstrual diary
1 secondary outcome
Uterine Doppler indices
Time frame: 3 months
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 21 Mar 2017.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibuprofen in people with Contraception, run by Assiut University 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 5 inclusion and 6 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 21 Mar 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 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.
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?
Number of bleeding days per month (time frame: 3 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 21 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.