NCT05207644

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_2 pregnancy

Timeline
Completed

Started Dec 2021

Shorter than P25 for phase_2 pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

December 9, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

December 9, 2021

Last Update Submit

June 14, 2022

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Safety Profile of medical abortion regimen

    To evaluate the safety profile of a user-friendly letrozole-misoprostol regimen.

    2 weeks

Study Arms (1)

Letrozole followed by misoprostol

OTHER

There is only one arm in this study.

Drug: 30 mg letrozole followed by 800 mcg misoprostol

Interventions

30 mg letrozole followed by 800 mcg misoprostolDRUG

30 mg letrozole on day 1 followed by 800 mcg misoprostol on day 3

Letrozole followed by misoprostol

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Planned Parenthood Salt Lake Health Center

Salt Lake City, Utah, 84102, United States

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Tara Shochet, PhD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Beverly Winikoff, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • David Turok, MD, MPH

    The University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2021

First Posted

January 26, 2022

Study Start

December 9, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

June 15, 2022

Record last verified: 2022-06

Locations

US(1)