Miscarriage in First TrimesterPhase 4NCT07160855
Letrozole Plus Misoprostol Versus Misoprostol Alone for Treating Women With Missed Miscarriage
A Phase 4 study testing Misoprostol (given vaginally) and Letrozole 5 mg in people with Miscarriage in First Trimester and Missed Miscarriage, run by Nishtar Medical University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn whether adding the medicine letrozole to Misoprostol helps women have a complete abortion more often than using Misoprostol alone for the treatment of missed miscarriage (when a pregnancy has stopped developing but has not yet passed naturally). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Miscarriage in First Trimester, Missed Miscarriage
- What is being tested?
- Misoprostol (given vaginally) and Letrozole 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 sitePakistan
- Study dates
- 13 May 2025to 12 Nov 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women up till 13th weeks of gestation according to last menstrual period (LMP) dates, confirmed on ultrasound
- Single intrauterine pregnancy
- Planned for termination due to missed miscarriage
Who cannot join
- Previous history of cesarean section
- Uterine scar due to previous procedure like myomectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Nishtar Medical University and Hospital
Multan, Punjab Province, 60000
Afrayshum T Principal Investigator, MBBS, +92 3336239197, afrayshumtariq@gmail.com
Rabia R Assistant Professor, FCPS, +92 3027336131, drraabia@yahoo.com
About this study
Official title: Comparison of Letrozole With Misoprostol Versus Misoprostol Alone in the Management of Missed Miscarriages
The goal of this clinical trial is to learn whether adding the medicine letrozole to Misoprostol helps women have a complete abortion more often than using Misoprostol alone for the treatment of missed miscarriage (when a pregnancy has stopped developing but has not yet passed naturally).
The main questions this study aims to answer are:
Read more
- Does taking letrozole for 3 days before misoprostol increase the chance of a complete abortion compared to misoprostol alone?
- Does the use of letrozole affect the time it takes for abortion to occur? Who can Join? i. Women up to 13 weeks of pregnancy (based on last menstrual period and confirmed by ultrasound) who have a missed miscarriage. ii. Only those with a single pregnancy are eligible. iii. Women with a previous cesarean section or uterine scar are not included.
What Will Happen in the Study A total of 92 women will take part.
Participants will be randomly assigned to one of two groups:
Group A: Letrozole tablets once daily for 3 days, followed by one dose of vaginal misoprostol.
Group B: Placebo tablets for maximum of 3 days, followed by one dose of vaginal misoprostol.
Doctors will monitor whether the abortion is complete within 24 hours. If it is not, other medical procedures will be offered as needed.
Products of conception will be examined to confirm abortion.
- Conditions
- Miscarriage in First Trimester, Missed Miscarriage
- Being tested
- Misoprostol (given vaginally), Letrozole 5 mg, Placebo
- Keywords
- Abortion, missed, Abortion, induced, Letrozole, Misoprostol, first trimester
- Medical subject headings
- Abortion, Incomplete, Abortion, Missed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol (given vaginally)Drug
Also called Cytotec, Arthrotec
800 micrograms of a single dose of vaginal misoprostol will be given
Letrozole 5 mgDrug
Also called femara
10 mg oral letrozole for 3 days will be given
PlaceboDrug
oral placebo for three days will be given
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol with placebo | Active comparator | Vaginal Misoprostol will be instituted after oral placebo Receives: Drug: Misoprostol (given vaginally); Drug: Placebo |
| Misoprostol with Letrozole | Experimental | After oral letrozole, vaginal Misoprostol will be instituted Receives: Drug: Misoprostol (given vaginally); Drug: Letrozole 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete abortion
The expulsion of both fetus and placenta without operative intervention and no retained products of conception confirmed on ultrasound.
Measured: From start of study medication after randomization to within 24-hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start13 May 2025
- Primary completion12 Nov 2025 (estimated)
- Study completion12 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Miscarriage in First TrimesterStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nishtar Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afrayshum Tariq, Nishtar Medical University
- Investigators
- Rabia R Assistant Professor, FCPS, Study chair, Nishtar Medical University and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160855
- Sponsor's protocol ID
- U1111-1327-5077
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abbasalizadeh F, Sahhaf F, Sadeghi-Shabestari P, Mirza-Aghazadeh-Attari M, Naghavi-Behzad M. Comparison Between Effect of Letrozole Plus Misoprostol and Misoprostol Alone in Terminating Non-Viable First Trimester Pregnancies: A Single Blind Randomized Trial. J Family Reprod Health. 2018 Mar;12(1):27-33.
PubMed 30647756
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Letrozole With Misoprostol Versus Misoprostol Alone in the Management of Missed Miscarriages
- ClinicalTrials.gov ID
- NCT07160855
- Acronym / sponsor ID
- U1111-1327-5077
- Conditions
- Miscarriage in First Trimester, Missed Miscarriage
- Keywords
- Abortion, missed, Abortion, induced, Letrozole, Misoprostol, first trimester
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Nishtar Medical UniversityUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 12 Nov 2025 (estimated)
- Study completion
- 12 Nov 2025 (estimated)
- First posted
- 8 Sep 2025 (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 goal of this clinical trial is to learn whether adding the medicine letrozole to Misoprostol helps women have a complete abortion more often than using Misoprostol alone for the treatment of missed miscarriage (when a pregnancy has stopped developing but has not yet passed naturally).
The main questions this study aims to answer are:
- Does taking letrozole for 3 days before misoprostol increase the chance of a complete abortion compared to misoprostol alone?
- Does the use of letrozole affect the time it takes for abortion to occur? Who can Join? i. Women up to 13 weeks of pregnancy (based on last menstrual period and confirmed by ultrasound) who have a missed miscarriage. ii. Only those with a single pregnancy are eligible. iii. Women with a previous cesarean section or uterine scar are not included.
What Will Happen in the Study A total of 92 women will take part.
Participants will be randomly assigned to one of two groups:
Group A: Letrozole tablets once daily for 3 days, followed by one dose of vaginal misoprostol.
Group B: Placebo tablets for maximum of 3 days, followed by one dose of vaginal misoprostol.
Doctors will monitor whether the abortion is complete within 24 hours. If it is not, other medical procedures will be offered as needed.
Products of conception will be examined to confirm abortion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol with placebo | Active comparator | Drug: Misoprostol (given vaginally), Drug: PlaceboVaginal Misoprostol will be instituted after oral placebo |
| Misoprostol with Letrozole | Experimental | Drug: Misoprostol (given vaginally), Drug: Letrozole 5 mgAfter oral letrozole, vaginal Misoprostol will be instituted |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women up till 13th weeks of gestation according to last menstrual period (LMP) dates, confirmed on ultrasound
- Single intrauterine pregnancy
- Planned for termination due to missed miscarriage
Key exclusion criteria (2 listed)
- Previous history of cesarean section
- Uterine scar due to previous procedure like myomectomy
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 |
|---|---|---|
| Misoprostol (given vaginally)Also: Cytotec, Arthrotec800 micrograms of a single dose of vaginal misoprostol will be given | Drug | Misoprostol with Letrozole, Misoprostol with placebo |
| Letrozole 5 mgAlso: femara10 mg oral letrozole for 3 days will be given | Drug | Misoprostol with Letrozole |
| Placebooral placebo for three days will be given | Drug | Misoprostol with placebo |
Primary outcome
Complete abortion
Time frame: From start of study medication after randomization to within 24-hours
The expulsion of both fetus and placenta without operative intervention and no retained products of conception confirmed on ultrasound.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 30647756Abbasalizadeh F, Sahhaf F, Sadeghi-Shabestari P, Mirza-Aghazadeh-Attari M, Naghavi-Behzad M. Comparison Between Effect of Letrozole Plus Misoprostol and Misoprostol Alone in Terminating Non-Viable First Trimester Pregnancies: A Single Blind Randomized Trial. J Family Reprod Health. 2018 Mar;12(1):27-33.
- Individual participant dataSharing planned: No
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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.
Rabia R Assistant Professor, FCPS study chair
Nishtar Medical University and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol (given vaginally) and Letrozole 5 mg in people with Miscarriage in First Trimester and Missed Miscarriage, run by Nishtar Medical University at 1 site in Pakistan.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Sep 2025. 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 Pakistan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Afrayshum T Principal Investigator, MBBS (+92 3336239197, afrayshumtariq@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete abortion (time frame: From start of study medication after randomization to within 24-hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07160855, which also lists 1 linked publication.
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 8 Sep 2025.