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NCT Number: NCT07767435

Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone

Termination of Second trimester Abortion with Letrozole and Misoprostol Compared to Misoprostol Alone

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

An online randomization program will be used to generate a random list and each patients' code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1 allocation ratio into two equal groups in a parallel manner:

  • Group I (Letrozole + Misoprostol): Patients will receive letrozole 2.5 mg orally the dose of letrozole is 4 tab once/day for 3 consecutive days, followed by vaginal misoprostol.
  • Group II (Misoprostol alone (: Patients will receive vaginal misoprostol alone using the same dosage schedule without letrozole pretreatment.

This study will be open-label due to different drugs and route of administrations used.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women aged 18-45 years.
  • Failed pregnancy.
  • Gestational age between 14 and 20weeks, confirmed by ultrasonography on the day of admission.
  • Hemoglobin concentration >9 g/dL.
  • Closed cervix.
  • Absence of products of conception in the cervical canal.
  • Exclusion Criteria:
  • Previous attempt to terminate the current pregnancy.
  • Molar pregnancy (hydatidiform mole).
  • Pathological uterine lesions including uterine fibroids and congenital uterine malformations.
  • Cardiac disease.
  • Renal disease.
  • Hemorrhagic disorders.
  • Body mass index (BMI) >35 kg/m².
  • Documented hypersensitivity or allergy to letrozole, misoprostol, or any of the study medications.

Treatment and study plan

· Misoprostol + letrozole

Drug
  • to compare the effect of letrozole plus misoprostol versus misoprostol alone for termination of second-trimester pregnancy.
  • to compare efficacy of letrozole and misoprostol versus misoprostol alone in theraputic abortion (living fetus) versus missed abortion.

Misoprostol Alone

Drug
  • to compare the effect of letrozole plus misoprostol versus misoprostol alone for termination of second-trimester pregnancy.
  • to compare efficacy of letrozole and misoprostol versus misoprostol alone in theraputic abortion (living fetus) versus missed abortion

Primary outcomes

  1. · Complete abortion rate.

    Time frame: 1 weak

Study contacts

Contact information is provided by the study sponsor or research team.

ahmed khalifa elsayed, resident

CONTACT

[email protected]

01142626766

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Termination of Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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