Letrozole in Induction of Abortion of Anembryonic Pregnancy

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05198050
Collaborator
(none)
90
1
3
5.9
15.2

Study Details

Study Description

Brief Summary

Some studies suggest the prescription of aromatase inhibitors prior to the use of misoprostol for inducing drug abortion. the aim of the study is to compare the effectiveness of various regimens of letrozole combined with misoprostol versus using misoprostol alone in inducing complete abortion in patients with blighted ovum.

Condition or Disease Intervention/Treatment Phase
  • Drug: Letrozole tablets
  • Drug: Misoprostol Tabets
  • Drug: Placebo tablets
N/A

Detailed Description

Some studies suggest prescription of aromatase inhibitors prior to the use of misoprostol for inducing drug abortion, increases the efficiency of the treatment regimen and also decreases the need for surgical interventions. Some conducted studies have mentioned reinforcing the impact of misoprostol with letrozole, but reaching the ideal dose still needs more studies, so in this study, the investigators will compare the effectiveness of various regimens of letrozole ( 10 mg/d for 3 days or a single dose of 20 mg) combined with misoprostol versus using misoprostol alone in inducing complete abortion in patients with a blighted ovum.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A randomized controlled trialA randomized controlled trial
Masking:
Single (Participant)
Primary Purpose:
Health Services Research
Official Title:
Letrozole Plus Misoprostol Versus Misoprostol Alone in Induction of Abortion of Anembryonic Pregnancy:
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
May 30, 2022
Anticipated Study Completion Date :
May 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: single dose letrozole tablets

starting from the first of January, patients will receive a single dose of letrozole (20 mg) two days, before starting misoprostol administration. Placebo tables with a similar appearance to letrozole will be administered the day before misoprostol administration and on the day of misoprostol administration.

Drug: Letrozole tablets
Letrozole is a third-generation non-steroidal aromatase inhibitor

Drug: Misoprostol Tabets
a synthetic prostaglandin medication
Other Names:
  • prostaglandin E1
  • Drug: Placebo tablets
    Placebo tables with a similar appearance to letrozole

    Active Comparator: multiple dose letrozole tablets

    starting from the first of January, patients will receive 10 mg letrozole daily for two days before the day of misoprostol administration and on the day of misoprostol administration.

    Drug: Letrozole tablets
    Letrozole is a third-generation non-steroidal aromatase inhibitor

    Drug: Misoprostol Tabets
    a synthetic prostaglandin medication
    Other Names:
  • prostaglandin E1
  • Active Comparator: misoprostol tablets

    starting from the first of January, patients will receive placebo tablets with a similar appearance to letrozole daily for two days before the day of misoprostol administration and on the day of misoprostol administration.

    Drug: Misoprostol Tabets
    a synthetic prostaglandin medication
    Other Names:
  • prostaglandin E1
  • Drug: Placebo tablets
    Placebo tables with a similar appearance to letrozole

    Outcome Measures

    Primary Outcome Measures

    1. Complete abortion [2 days]

      no emergency or elective curettage was necessary until next menstruation

    Secondary Outcome Measures

    1. Induction-to-abortion interval [2 days]

      the interval between administration of misoprostol)

    2. Adverse effects of Misoprostol [2 days]

      diarrhea, abdominal cramps, fever and sweating.

    3. Adverse effects of Letrozole [2 days]

      hot flushes, drowsiness and nausea.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • first trimester of pregnancy

    • pregnancy duration less than 12 weeks based on LMP.

    • non-viable fetus (blighted ovum)

    Exclusion Criteria:
    • No heart disease,

    • No asthma

    • No History of thromboembolism

    • No History of cancer

    • No renal failure

    • No liver diseases

    • History of allergy to misoprostol or letrozole drugs.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Cairo Egypt 12613

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Marwa M Abdalla, MD, Kasralainy teaching hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Marwa Mohamed Abdalla, Clinical professor of Obstetrics and Gynecology, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05198050
    Other Study ID Numbers:
    • Letrozole and abortion
    First Posted:
    Jan 20, 2022
    Last Update Posted:
    Jan 20, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Marwa Mohamed Abdalla, Clinical professor of Obstetrics and Gynecology, Cairo University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 20, 2022