Pregnancy EarlyPhase 2/3NCT06492889
Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens
A Phase 2/3 study testing Levonorgestrel and Mifepristone in people with Pregnancy Early and Pregnancy Related, run by Gynuity Health Projects.
Trial summary
The goal of this trial is to examine the efficacy and acceptability of two medication regimens at inducing a return of menses when used 2-8 days after a missed period. The first regimen consists of one dose of 1.5 mg levonorgestrel followed one to two days later by one dose of 200 mg mifepristone. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Early, Pregnancy Related
- What is being tested?
- Levonorgestrel and Mifepristone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- No sites listed yet
- Study dates
- 22 Jul 2024to 30 Jun 2025
- Phase
- Phase 2/3
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 15-49 years
- General good health
- Does not want to be pregnant
- History of regular monthly menstrual cycles (+/- 3 days)
- Missed menses of 2 to 8 days
- Sexual activity in the past month
Show all 9Show fewer
- Willing and able to sign consent forms
- Willing to return for a follow-up visit
- Willing to provide urine sample at enrollment and follow-up
Who cannot join
- Known allergies or contraindications to either study drug
- Symptoms or risk factors for ectopic pregnancy
- Current use of an IUD, contraceptive implant or injectable
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Trial Comparing Progestin With Mifepristone Versus Mifepristone Alone for Use as Missed Period Pills
The goal of this trial is to examine the efficacy and acceptability of two medication regimens at inducing a return of menses when used 2-8 days after a missed period. The first regimen consists of one dose of 1.5 mg levonorgestrel followed one to two days later by one dose of 200 mg mifepristone. The second regimen will consist of one dose of a placebo pill, followed one to two days later by one dose of 200 mg mifepristone.
The investigators will assess and compare the efficacy of both regimens (proportion of women in each group not pregnant at follow-up who were determined to be pregnant at enrollment), and the effectiveness of both regimens (proportion of all participants not pregnant at follow-up among all participants enrolled)
- Conditions
- Pregnancy Early, Pregnancy Related
- Being tested
- Levonorgestrel, Mifepristone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevonorgestrelDrug
Participants in the levonorgestrel plus mifepristone group will receive one tablet of 1.5 mg levonorgestrel
MifepristoneDrug
Participants in both groups will receive one tablet of 200 mg mifepristone
| Study group | Role | What they receive |
|---|---|---|
| Levonorgestrel plus mifepristone | Experimental | Women randomized to take one pill containing 1.5 mg levonorgestrel followed one to two days later by 200 mg mifepristone. Receives: Drug: Levonorgestrel; Drug: Mifepristone |
| Placebo plus mifepristone | Experimental | Women randomized to take one placebo pill followed one to two days later by 200 mg mifepristone. Receives: Drug: Mifepristone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the missed period pills regimen
Proportion of women not pregnant at follow-up who were determined to be pregnant at enrollment
Measured: Two weeks
Effectiveness of the missed period pills regimen
Proportion of women not pregnant at follow-up among all women enrolled, including those who were pregnant and not pregnant at enrollment
Measured: Two weeks
Secondary outcomes (3)
Effectiveness at inducing return of menses within 10 days of missed menses
Proportion of participants who experience menstrual bleeding after taking the study medications
Measured: One to two weeks
Safety/side effects
Incidence of side effects and complications
Measured: Two weeks
Acceptability
Proportion of participants who report that the missed period pills service was acceptable or highly acceptable
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start22 Jul 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy EarlyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Cuidado Integral de la Mujer, Gineclinic, S.C., Servicios de Salud Medieg, A. C
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492889
- Sponsor's protocol ID
- 8007
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Progestin With Mifepristone Versus Mifepristone Alone for Use as Missed Period Pills
- ClinicalTrials.gov ID
- NCT06492889
- Acronym / sponsor ID
- 8007
- Conditions
- Pregnancy Early, Pregnancy Related
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Cuidado Integral de la Mujer, Gineclinic, S.C., Servicios de Salud Medieg, A. C
- Study start
- 22 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 9 Jul 2024 (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.
The goal of this trial is to examine the efficacy and acceptability of two medication regimens at inducing a return of menses when used 2-8 days after a missed period. The first regimen consists of one dose of 1.5 mg levonorgestrel followed one to two days later by one dose of 200 mg mifepristone. The second regimen will consist of one dose of a placebo pill, followed one to two days later by one dose of 200 mg mifepristone.
The investigators will assess and compare the efficacy of both regimens (proportion of women in each group not pregnant at follow-up who were determined to be pregnant at enrollment), and the effectiveness of both regimens (proportion of all participants not pregnant at follow-up among all participants enrolled)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levonorgestrel plus mifepristone | Experimental | Drug: Levonorgestrel, Drug: MifepristoneWomen randomized to take one pill containing 1.5 mg levonorgestrel followed one to two days later by 200 mg mifepristone. |
| Placebo plus mifepristone | Experimental | Drug: MifepristoneWomen randomized to take one placebo pill followed one to two days later by 200 mg mifepristone. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 15-49 years
- General good health
- Does not want to be pregnant
- History of regular monthly menstrual cycles (+/- 3 days)
- Missed menses of 2 to 8 days
Key exclusion criteria (3 listed)
- Known allergies or contraindications to either study drug
- Symptoms or risk factors for ectopic pregnancy
- Current use of an IUD, contraceptive implant or injectable
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 |
|---|---|---|
| LevonorgestrelParticipants in the levonorgestrel plus mifepristone group will receive one tablet of 1.5 mg levonorgestrel | Drug | Levonorgestrel plus mifepristone |
| MifepristoneParticipants in both groups will receive one tablet of 200 mg mifepristone | Drug | Levonorgestrel plus mifepristone, Placebo plus mifepristone |
Primary outcome
Efficacy of the missed period pills regimen
Time frame: Two weeks
Proportion of women not pregnant at follow-up who were determined to be pregnant at enrollment
Effectiveness of the missed period pills regimen
Time frame: Two weeks
Proportion of women not pregnant at follow-up among all women enrolled, including those who were pregnant and not pregnant at enrollment
3 secondary outcomes
Effectiveness at inducing return of menses within 10 days of missed menses
Time frame: One to two weeks
Safety/side effects
Time frame: Two weeks
Acceptability
Time frame: Two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
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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.
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Levonorgestrel and Mifepristone in people with Pregnancy Early and Pregnancy Related, run by Gynuity Health Projects.
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 9 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manuel Bousieguez (212-448-1230, mbousieguez@gynuity.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the missed period pills regimen (time frame: Two weeks). The study lists 2 primary outcomes in all. 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 18 Jul 2024.