Clinical Trials Logo
  1. Home
  2. Pregnancy
  3. NCT05207644
  4. Details
NCT05207644 Clinical Trial

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

Pregnancy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05207644
Other study ID # 1048
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 9, 2021
Est. completion date April 30, 2022

Study information
Verified date June 2022
Source Gynuity Health Projects
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Planned Parenthood Salt Lake Health Center Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety Profile of medical abortion regimen To evaluate the safety profile of a user-friendly letrozole-misoprostol regimen. 2 weeks
See also
  Status Clinical Trial Phase
Completed NCT03442582 - Afluria Pregnancy Registry
Terminated NCT02161861 - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study N/A
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Enrolling by invitation NCT05415371 - Persistent Poverty Counties Pregnant Women With Medicaid N/A
Completed NCT04548102 - Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman N/A
Completed NCT03218956 - Protein Requirement During Lactation N/A
Completed NCT02191605 - Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy N/A
Completed NCT02223637 - Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Recruiting NCT06049953 - Maternal And Infant Antipsychotic Study
Completed NCT02577536 - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting NCT06336434 - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy Phase 1/Phase 2
Not yet recruiting NCT05412238 - Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months N/A
Not yet recruiting NCT04786587 - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Not yet recruiting NCT05028387 - Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
Completed NCT02683005 - Study of Hepatitis C Treatment During Pregnancy Phase 1
Completed NCT02783170 - Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women Phase 4
Recruiting NCT02507180 - Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
Recruiting NCT02619188 - Nutritional Markers in Normal and Hyperemesis Pregnancies N/A
Recruiting NCT02564250 - Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women N/A
Terminated NCT02537145 - PregnanT Moms Measure - Do-It-Yourself Health Monitoring and Simulation of Health in Pregnant Women