ContraceptionPhase 3NCT04312061
Effect of Oral Tramadol Administration Prior to IUD Insertion
A Phase 3 study testing oral tramadol in people with Contraception, run by Cairo University.
Trial summary
the aim of the study is to evaluate the safety and efficacy of oral tramadol administration in reducing pain during LNG- IUD insertion in adolescents and young women Read more about this study
- Who is it for?
- Ages 14 to 25 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- oral tramadol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2020to 5 Jul 2020
- 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 14 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- nulliparous adolescents and young women requesting LNG-IUD insertion
Who cannot join
- parous women, contraindications to LNG-IUD insertion and allergy or contraindications to tramadol
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Efficacy of Oral Tramadol Administration in Reducing Pain During Levonorgestrel Intrauterine Device Insertion in Adolescents and Young Women: a Randomized Controlled Trial
the aim of the study is to evaluate the safety and efficacy of oral tramadol administration in reducing pain during LNG- IUD insertion in adolescents and young women
- Conditions
- Contraception
- Being tested
- oral tramadol, Placebo oral tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral tramadolDrug
oral tramadol tablet 5o mg given 1 hour before LNG-IUD insertion
Placebo oral tabletDrug
oral placebo tablet given 1 hour before LNG-IUD insertion
| Study group | Role | What they receive |
|---|---|---|
| oral tramadol | Experimental | oral tramadol tablet 5o mg given 1 hour before LNG-IUD insertion Receives: Drug: oral tramadol |
| placebo | Placebo comparator | oral placebo tablet given 1 hour before LNG-IUD insertion Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain during IUD insertion
intensity of patient-perceived pain at time of IUD insertion, using a visual analog scale. The VAS scale is graded from 0 to 10 on a 10 cm horizontal straight line, where
'zero' corresponds to no pain at all, and '10' to the worst possible pain imaginable.
Measured: 5 minutes
Secondary outcomes (1)
duration of the procedure
duration of IUD insertion from speculum in to speculum out in minutes
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start30 Mar 2020 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion5 Jul 2020 (estimated)
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 Cairo 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312061
- Sponsor's protocol ID
- tramadol IUD
- Status last verified
- Mar 2020
- First submitted
- 14 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Oral Tramadol Administration in Reducing Pain During Levonorgestrel Intrauterine Device Insertion in Adolescents and Young Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04312061
- Acronym / sponsor ID
- tramadol IUD
- Conditions
- Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Mar 2020 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 5 Jul 2020 (estimated)
- First posted
- 18 Mar 2020 (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.
the aim of the study is to evaluate the safety and efficacy of oral tramadol administration in reducing pain during LNG- IUD insertion in adolescents and young women
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral tramadol | Experimental | Drug: oral tramadoloral tramadol tablet 5o mg given 1 hour before LNG-IUD insertion |
| placebo | Placebo comparator | Drug: Placebo oral tabletoral placebo tablet given 1 hour before LNG-IUD insertion |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- nulliparous adolescents and young women requesting LNG-IUD insertion
Key exclusion criteria (1 listed)
- parous women, contraindications to LNG-IUD insertion and allergy or contraindications to tramadol
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 |
|---|---|---|
| oral tramadoloral tramadol tablet 5o mg given 1 hour before LNG-IUD insertion | Drug | oral tramadol |
| Placebo oral tabletoral placebo tablet given 1 hour before LNG-IUD insertion | Drug | placebo |
Primary outcome
pain during IUD insertion
Time frame: 5 minutes
intensity of patient-perceived pain at time of IUD insertion, using a visual analog scale. The VAS scale is graded from 0 to 10 on a 10 cm horizontal straight line, where 'zero' corresponds to no pain at all, and '10' to the worst possible pain imaginable.
1 secondary outcome
duration of the procedure
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
Related trials for Contraception
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oral tramadol in people with Contraception, run by Cairo University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AHMED SAMY (+201100681167, ahmedsamy8233@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain during IUD insertion (time frame: 5 minutes). 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 18 Mar 2020.