Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone

NCT05940233 | Recruiting DMC

• 1 other identifier: 014/2566
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of rate of complete abortion between Letrozole plus Misoprostol versus Misoprostol alone in first trimester pregnancy

Conditions

Medical; Abortion, Fetus

Outcome Measures

Primary Outcomes (1)

• Rate of complete abortion

  Rate of complete abortion

  up to 7 days

Secondary Outcomes (2)

• Side effect between both group

  up to 7 days

• induced to abortion time between both group

  up to 6 months

Study Arms (2)

Letrozole plus Misoprostol

EXPERIMENTAL

We give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4.

Drug: Letrozole

Misoprostol

ACTIVE COMPARATOR

We give only Misoprostol 800 mcg SL.

Drug: Letrozole

Interventions

Letrozole DRUG

In the experimental group, we give the Letrozole 10 mg PO daily on the 4th day before Misoprostol 800 mcg SL on the 4th day. In the control group, we give Misoprostol 800 mcg SL on the 4th day.

Also known as: Femara

Letrozole plus Misoprostol; Misoprostol

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diafnoed Early pregnancy loss by TVS according to ACOG Practice bulletin 2018
• GA \<= 14 weeks
• Os open \<= 1 cm and no conceptus per os
• Hematicrit \>= 30
• Systolic blood pressure \>= 95 mmHg
• Informed consent done and can follow up and comunicate in Thai language

You may not qualify if:

• Allerguc to Letrozole or Misoprostol
• Intrauterine contraceptive device use
• Breast feeding
• Diagnoed with ectopic pregnancy or undiagnoed adnexal mass
• Severe or recurrent liver disease or AST or ALT more than or equal to 3 times of upper normal limit
• Multiple pregnancy
• Myoma uteri that involves the endometrium ex. Submucous myoma uteri
• Thromboembolism or has a history of thromboembolism
• Serum creatinine \>= 2

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead

Study Sites (1)

Sutinee Srimahachota

Bangkok, Yannawa, 10120, Thailand

RECRUITING

MeSH Terms

Interventions

Letrozole

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• ชื่นฤทัย ยี่เขียน, Ph.D.

  Queen Savang Vadhana Memorial Hospital, Thailand

  STUDY CHAIR

Central Study Contacts

Sutinee Srimahachota, M.D.

CONTACT

0847202666; srimahachota@gmail.com

Chuenrutai Yeekian, Ph.D.

CONTACT

0818624534; jayeekian88@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We devide patient into 2 groups, intervention and control group. In intervention group we give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4. In control group we give only Misoprostol 800 mcg SL.

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: July 11, 2023
• Study Start: June 30, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)