ContraceptionPhase 3NCT03790371
Vaginal Misoprostol Before Intrauterine Contraceptive Device Insertion
A Phase 3 study testing Misoprostol in people with Contraception, run by Ain Shams University at 1 site in Egypt.
Trial summary
the current study was conducted to assess efficacy of vaginal misoprostol before IUD insertion following previous insertion failure Read more about this study
- Who is it for?
- Ages 20 to 44 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2015to 1 Aug 2016
- 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 20 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- One previous failed attempt of IUD insertion.
Who cannot join
- Uterine fibroid distorting the cavity.
- Anatomical uterine abnormality with distortion of the cavity
- Current pelvic inflammatory disease or recently treated pelvic inflammatory disease (PID) in the last three months.
- Current purulent cervicitis (chlamydia or gonorrhea).
- Immediately after septic abortion.
- Uterus size less than 6 cm and more than 9 cm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaginal Misoprostol Before Intrauterine Contraceptive Device Insertion Following Previous Insertion Failure
the current study was conducted to assess efficacy of vaginal misoprostol before IUD insertion following previous insertion failure
- Conditions
- Contraception
- Being tested
- Misoprostol, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
vaginal misoprostol prior IUD insertion
PlacebosDrug
vaginal placebo tablet prior IUD insertion
| Study group | Role | What they receive |
|---|---|---|
| misoprostol group | Active comparator | misoprostol (misotac® sigma pharmaceutical industries) 200 mcg vaginally applied ten and four hours prior to the second attempt of IUD insertion Receives: Drug: Misoprostol |
| placebo | Placebo comparator | while the control group received a placebo tablet in the same regimen as the study group. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
the success rate for IUD insertion.
the success of IUD insertion after previous attempt failure
Measured: four hours after misoprostol dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start1 Oct 2015
- Primary completion1 Aug 2016
- Study completion1 Aug 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 Ain Shams 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Rasheedy Ali, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790371
- Sponsor's protocol ID
- Ain Shams University MH
- Status last verified
- Dec 2018
- First submitted
- 27 Dec 2018
- Last updated
- 31 Dec 2018
- 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 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Misoprostol Before Intrauterine Contraceptive Device Insertion Following Previous Insertion Failure
- ClinicalTrials.gov ID
- NCT03790371
- Acronym / sponsor ID
- Ain Shams University MH
- Conditions
- Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Aug 2016 (actual)
- Study completion
- 1 Aug 2016 (actual)
- First posted
- 31 Dec 2018 (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 current study was conducted to assess efficacy of vaginal misoprostol before IUD insertion following previous insertion failure
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 |
|---|---|---|
| misoprostol group | Active comparator | Drug: Misoprostolmisoprostol (misotac® sigma pharmaceutical industries) 200 mcg vaginally applied ten and four hours prior to the second attempt of IUD insertion |
| placebo | Placebo comparator | Drug: Placeboswhile the control group received a placebo tablet in the same regimen as the study group. |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- One previous failed attempt of IUD insertion.
Key exclusion criteria (6 listed)
- Uterine fibroid distorting the cavity.
- Anatomical uterine abnormality with distortion of the cavity
- Current pelvic inflammatory disease or recently treated pelvic inflammatory disease (PID) in the last three months.
- Current purulent cervicitis (chlamydia or gonorrhea).
- Immediately after septic abortion.
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 |
|---|---|---|
| Misoprostolvaginal misoprostol prior IUD insertion | Drug | misoprostol group |
| Placebosvaginal placebo tablet prior IUD insertion | Drug | placebo |
Primary outcome
the success rate for IUD insertion.
Time frame: four hours after misoprostol dose
the success of IUD insertion after previous attempt failure
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 31 Dec 2018.
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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 3 study testing Misoprostol in people with Contraception, run by Ain Shams 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 1 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 31 Dec 2018. 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. 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?
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?
the success rate for IUD insertion. (time frame: four hours after misoprostol dose). 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 31 Dec 2018.