Complete MiscarriagePhase 2/3NCT02401425
Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion
A Phase 2/3 study testing Letrozole and Misoprostol in people with Complete Miscarriage, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this study is to compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complete Miscarriage
- What is being tested?
- Letrozole and Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 423 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2015to Sep 2015
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Maternal age more than 18 years old (age of legal consent).
- Gestational age less than 13 weeks.
- Hemoglobin >10 g/dL.
- BMI between 25 kg/m2 and 35 kg/m2.
- Missed abortion.
- Living fetus with multiple congenital malformations incompatible with life.
Who cannot join
- Maternal age less than 18 years old.
- Gestational age more than 12 weeks.
- Hemoglobin <10 g/dL.
- Anencephaly.
- Fibroid uterus.
- BMI less than 25kg/m2 and more than 35kg/m2.
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- Coagulopathy.
- History or evidence of adrenal pathology.
- Previous attempts for induction of abortion in the current pregnancy.
- Allergy to misoprostol or letrozole.
- Medical disorder that contraindicate induction of abortion (e.g. heart failure).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion: Randomised Controlled Trial
The purpose of this study is to compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.
Read the detailed description
Primary outcome:
Incidence of complete miscarriage (complete expulsion of the products of conception with no need for surgical intervention within one week from the first dose of misoprostol)
Secondary outcome:
Need for surgical evacuation of the products of conception
- Incomplete expulsion of the products of conception (incomplete miscarriage).
- Considerable bleeding necessitating immediate surgical evacuation. Maternal morbidity
- Major side effects (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion)
- Minor side effects (fever, rigors, nausea, vomiting) Patient's compliance and adherence to treatment Hemoglobin and hematocrit deficit
- Conditions
- Complete Miscarriage
- Being tested
- Letrozole, Misoprostol, Placebo
- Keywords
- Letrozole, Misoprostol, First-Trimester, Pretreatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called femara
MisoprostolDrug
Also called Misotac; Misotec; Cytotec
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| letrozole | Active comparator | Women will receive three tablets of letrozole(FemaraR, NOVARTIS) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses. Receives: Drug: Letrozole; Drug: Misoprostol |
| placebo | Placebo comparator | Women will receive three tablets of placebo as a single dose, for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses. Receives: Drug: Misoprostol; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complete abortion
complete expulsion of the products of conception with no need for surgical intervention within one week from the first dose of misoprostol
Measured: 1 week
Secondary outcomes (3)
Need for surgical evacuation of the products of conception
Need for surgical evacuation of the products of conception
- Incomplete expulsion of the products of conception (incomplete miscarriage).
- Considerable bleeding necessitating immediate surgical evacuation.
Measured: 1 week
Maternal morbidity
Maternal morbidity
- Major side effects (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion)
- Minor side effects (fever, rigors, nausea, vomiting)
Measured: 1 week
Hemoglobin and hematocrit deficit
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete MiscarriageStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed S Sweed, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401425
- Sponsor's protocol ID
- 1984
- Status last verified
- Sep 2015
- First submitted
- 25 Feb 2015
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02401425
- Acronym / sponsor ID
- 1984
- Conditions
- Complete Miscarriage
- Keywords
- Letrozole, Misoprostol, First-Trimester, Pretreatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Mar 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 purpose of this study is to compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.
Detailed description
Primary outcome:
Incidence of complete miscarriage (complete expulsion of the products of conception with no need for surgical intervention within one week from the first dose of misoprostol)
Secondary outcome:
Need for surgical evacuation of the products of conception
- Incomplete expulsion of the products of conception (incomplete miscarriage).
- Considerable bleeding necessitating immediate surgical evacuation. Maternal morbidity
- Major side effects (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion)
- Minor side effects (fever, rigors, nausea, vomiting) Patient's compliance and adherence to treatment Hemoglobin and hematocrit deficit
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 |
|---|---|---|
| letrozole | Active comparator | Drug: Letrozole, Drug: MisoprostolWomen will receive three tablets of letrozole(FemaraR, NOVARTIS) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses. |
| placebo | Placebo comparator | Drug: Misoprostol, Other: PlaceboWomen will receive three tablets of placebo as a single dose, for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Maternal age more than 18 years old (age of legal consent).
- Gestational age less than 13 weeks.
- Hemoglobin >10 g/dL.
- BMI between 25 kg/m2 and 35 kg/m2.
- Missed abortion.
Key exclusion criteria (11 listed)
- Maternal age less than 18 years old.
- Gestational age more than 12 weeks.
- Hemoglobin <10 g/dL.
- Anencephaly.
- Fibroid uterus.
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 |
|---|---|---|
| LetrozoleAlso: femara | Drug | letrozole |
| MisoprostolAlso: Misotac; Misotec; Cytotec | Drug | letrozole, placebo |
| Placebo | Other | placebo |
Primary outcome
Incidence of complete abortion
Time frame: 1 week
complete expulsion of the products of conception with no need for surgical intervention within one week from the first dose of misoprostol
3 secondary outcomes
Need for surgical evacuation of the products of conception
Time frame: 1 week
Maternal morbidity
Time frame: 1 week
Hemoglobin and hematocrit deficit
Time frame: 1 week
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 29 Sep 2015.
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 2/3 study testing Letrozole and Misoprostol in people with Complete Miscarriage, 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 6 inclusion and 11 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 29 Sep 2015. 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 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?
Incidence of complete abortion (time frame: 1 week). 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 29 Sep 2015.