Letrozole and Misoprostol for Termination of Pregnancy up... | NCT05207644

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

NCT05207644

Sponsor

Gynuity Health Projects

Status

Completed

Last Update Posted

Jun 15, 2022Actual

Enrollment

40Actual

Phase

Phase 2

Conditions

Pregnancy

Interventions

30 mg letrozole followed by 800 mcg misoprostol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2021Actual

Primary Completion Date

Apr 30, 2022Actual

Completion Date

Apr 30, 2022Actual

First Submitted Date

Dec 9, 2021

First Submission Date that Met QC Criteria

Jan 13, 2022

First Posted Date

Jan 26, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2022

Last Update Posted Date

Jun 15, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Letrozole followed by misoprostol	Other	There is only one arm in this study.	Drug: 30 mg letrozole followed by 800 mcg misoprostol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
30 mg letrozole followed by 800 mcg misoprostol	Drug	30 mg letrozole on day 1 followed by 800 mcg misoprostol on day 3	Letrozole followed by misoprostol

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Planned Parenthood Salt Lake Health Center		Salt Lake City	Utah	84102	United States

Intervention Browse Module

MeSH Terms

ID	Term
D016595	Misoprostol

Ancestor Terms

ID	Term
D011459	Prostaglandins E, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids

Browse Leaves

Not provided

Browse Branches

Not provided