PregnancyPhase 2NCT05207644
Letrozole and Misoprostol for Termination of Pregnancy up to 63 Days' Gestation
A Phase 2 study testing 30 mg letrozole followed by 800 mcg misoprostol in people with Pregnancy, run by Gynuity Health Projects at 1 site in United States.
Trial summary
Study to determine if a user-friendly medical abortion regimen using letrozole and misoprostol is safe and acceptable. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- 30 mg letrozole followed by 800 mcg misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2021to 30 Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Currently breastfeeding
- Twin or multiple pregnancy
- History of liver disease or abnormal liver function
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood Salt Lake Health Center
Salt Lake City, Utah, 84102
About this study
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
Study to determine if a user-friendly medical abortion regimen using letrozole and misoprostol is safe and acceptable.
- Conditions
- Pregnancy
- Being tested
- 30 mg letrozole followed by 800 mcg misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 mg letrozole followed by 800 mcg misoprostolDrug
30 mg letrozole on day 1 followed by 800 mcg misoprostol on day 3
| Study group | Role | What they receive |
|---|---|---|
| Letrozole followed by misoprostol | Other | There is only one arm in this study. Receives: Drug: 30 mg letrozole followed by 800 mcg misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Profile of medical abortion regimen
To evaluate the safety profile of a user-friendly letrozole-misoprostol regimen.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start9 Dec 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tara Shochet, PhD, MPH, Principal investigator, Gynuity Health ProjectsBeverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsDavid Turok, MD, MPH, Principal investigator, The University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207644
- Sponsor's protocol ID
- 1048
- Status last verified
- Jun 2022
- First submitted
- 9 Dec 2021
- Last updated
- 15 Jun 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05207644
- Acronym / sponsor ID
- 1048
- Conditions
- Pregnancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to determine if a user-friendly medical abortion regimen using letrozole and misoprostol is safe and acceptable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Letrozole followed by misoprostol | Other | Drug: 30 mg letrozole followed by 800 mcg misoprostolThere is only one arm in this study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 30 mg letrozole followed by 800 mcg misoprostol30 mg letrozole on day 1 followed by 800 mcg misoprostol on day 3 | Drug | Letrozole followed by misoprostol |
Primary outcome
Safety Profile of medical abortion regimen
Time frame: 2 weeks
To evaluate the safety profile of a user-friendly letrozole-misoprostol regimen.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tara Shochet, PhD, MPH principal investigator
Gynuity Health Projects
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
David Turok, MD, MPH principal investigator
The University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 30 mg letrozole followed by 800 mcg misoprostol in people with Pregnancy, run by Gynuity Health Projects at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Profile of medical abortion regimen (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.