ClinicalTrials.gg
Status unknownNCT04215835Updated Jan 2, 2020

Letrozole Pretreatment With Misoprostol Induction of Abortion In First-Trimester Missed Miscarriage

A Phase 4 interventional study of letrozole then misoprostol and placebo then misoprostol in Missed Abortion, sponsored by Cairo University. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-02.

Sponsored by Cairo University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy among women with one or more previous cesarean deliveries.

02

Conditions studied

  • Missed Abortion

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03

In context

Abortion, Missed

48 studies on the registry are indexed under Abortion, Missed; 10 are open to participants now.

This study's planned enrollment of 200 is above the median of 110 across 41 interventional studies indexed under Abortion, Missed.

Browse Abortion, Missed studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Gestational age less than 64 days gestation (\<9 wks).
  • >10 g/dL.
  • between 18.5 kg/m2 and 25 kg/m2.
  • Missed abortion.
  • previous one or more cesarean delivaries

Exclusion criteria

Exclusion Criteria:

  • Molar pregnancy.
  • Fibroid uterus.
  • Uterine anomalies.
  • Coagulopathy.
  • Medical disorder that contraindicate induction of abortion (e.g. heart failure).
  • Previous attempts for induction of abortion in the current pregnancy.
  • Allergy to misoprostol or letrozole.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    study group

    3 tablets of Letrozole 2.5 mg will be given as single daily dose, 7.5 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum two doses.

    Drug: letrozole then misoprostol

  • Placebo comparator
    control group

    three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses

    Drug: placebo then misoprostol

Interventions

  • Drugletrozole then misoprostol

    Drug: Letrozole 2.5mg total dose 7.5 mg per day for 3 days Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion

  • Drugplacebo then misoprostol

    Drug: Placebo placebo for 3 days Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion

06

What researchers measure

Primary outcomes

  1. induction to abortion time

    induction to abortion time

    Time frame: 6 hours

  2. Incidence of complete miscarriage

    Incidence of complete miscarriage

    Time frame: 6 hours

Secondary outcomes

  1. Need for surgical evacuation of the products of conception

    Need for surgical evacuation of the products of conception

    Time frame: 6 hours

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2020; primary completion for Apr 2020, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 30, 2019
First posted
Jan 2, 2020
StartEst.
Jan 5, 2020
Primary completionEst.
Apr 5, 2020
CompletionEst.
Apr 10, 2020
Last update
Jan 2, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04215835
Lead sponsor
Cairo University
Responsible party
Ahmed Samy aly ashour (assistant professor obstetrics and gynecology, Cairo University) — Principal investigator
First posted
Jan 2, 2020
Start date
Jan 5, 2020 (estimated)
Primary completion
Apr 5, 2020 (estimated)
Completion
Apr 10, 2020 (estimated)
Last update
Jan 2, 2020

Study contacts

AHMED SAMY
Contact
ahmedsamy8233@gmail.com
+201100681167
AHMED SAMY
principal investigator · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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