Letrozole and Misoprostol for Termination of Pregnancy up to 63 Days' Gestation

Letrozole and Misoprostol for Termination of Pregnancy up to 63 Days' Gestation: A Pilot Study to Evaluate the Safety and Acceptably of a User-friendly Regimen

Study to determine if a user-friendly medical abortion regimen using letrozole and misoprostol is safe and acceptable.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Drug: 30 mg letrozole followed by 800 mcg misoprostol

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • Planned Parenthood Salt Lake Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnancy ≤ 63 days gestational age by ultrasound seeking termination of pregnancy
• Pregnancy visible on ultrasound
• Speaks English or Spanish
• Willing and able to return for follow-up appointment

Exclusion Criteria:

• People with gestations > 63 days gestational age
• Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
• Pregnancy of unknown location
• IUD or contraceptive implant in place
• History of allergy to letrozole or misoprostol
• Unable to return for clinic-based follow-up
• Currently breastfeeding
• Twin or multiple pregnancy
• History of liver disease or abnormal liver function

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Letrozole followed by misoprostol; There is only one arm in this study.	Drug: 30 mg letrozole followed by 800 mcg misoprostol; 30 mg letrozole on day 1 followed by 800 mcg misoprostol on day 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Profile of medical abortion regimen	To evaluate the safety profile of a user-friendly letrozole-misoprostol regimen.	2 weeks

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Investigators: Principal Investigator: David Turok, MD, MPH, The University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Letrozole; Misoprostol
• Other Study ID Numbers: 1048

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes