Missed Menstrual PeriodPhase 2NCT04676776
Assessing Use Of Mifepristone After Progestin Priming For Use As "Missed Period Pills"
A Phase 2 study testing Levonorgestrel and Mifepristone in people with Missed Menstrual Period, run by Gynuity Health Projects at 1 site in Mexico.
Trial summary
This study will assess the effectiveness and acceptability of a 3-day missed period pill regimen. 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
- Missed Menstrual Period
- What is being tested?
- Levonorgestrel and Mifepristone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteMexico
- Study dates
- 25 Jan 2021to Dec 2021
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-49 years
- General good health
- Does not want to be pregnant
- History of regular monthly menstrual cycles (±3 days)
- Missed menses of 1 to 10 days as verified by report of last menstrual period
- 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 a urine sample at enrollment and at follow-up
Who cannot join
- Known allergies or contraindications to mifepristone
- Symptoms of or risk factors for ectopic pregnancy, such as vaginal bleeding or spotting within the past week; unilateral pelvic pain or significant bilateral pelvic pain within the past week; prior ectopic pregnancy; prior permanent contraception or other tubal surgery
- Current use of an IUD, contraceptive implant or injectable
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Cuidado Integral de la Mujer, Gineclinic, S.C
Mexico City
Karla Figueroa Flores, MD
Karla Figueroa Flores, MD
About this study
This study will assess the effectiveness and acceptability of a 3-day missed period pill regimen.
Read the detailed description
Missed period pills (MPPs) are medications used for uterine evacuation among women with late menses who have not confirmed pregnancy status. Provision of MPPs could expand reproductive service options for individuals in a variety of settings. This study will collect data on the efficacy, safety, and acceptability of a 3-day missed period pill regimen among individuals with missed menses of 1-10 days
- Conditions
- Missed Menstrual Period
- Being tested
- Levonorgestrel, Mifepristone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevonorgestrelDrug
All participants receive 1.5 mg levonorgestrel on day 1
MifepristoneDrug
All participants receive 200 mg mifepristone on day 3
| Study group | Role | What they receive |
|---|---|---|
| Missed period pill regimen | Experimental | 1.5 mg levonorgestrel given on day 1 200 mg mifepristone given on day 3 Receives: Drug: Levonorgestrel; Drug: Mifepristone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of missed period pill regimen
Proportion of participants not pregnant at follow-up among those who were pregnant at enrollment
Measured: Up to 28 days after administration of levonorgestrel
Secondary outcomes (4)
Effectiveness of missed period pill regimen
Proportion of all enrolled participants not pregnant at follow-up (among those who were and were not pregnant at enrollment)
Measured: Up to 28 days after administration of levonorgestrel
Effectiveness at inducing return of menses within 10 days
Proportion of participants reporting return of missed menses within 10 days of initiating missed period pill regimen
Measured: Up to 10 days after administration of levonorgestrel
Occurrence of treatment-emergent adverse events and/or side effects (safety and tolerability)
Proportion of participants who report adverse events and/or side effects
Measured: Up to 28 days after administration of levonorgestrel
Acceptability of missed period pills
Proportion of participants who report that the missed period pill service was acceptable or highly acceptable to them
Measured: Up to 28 days after administration of levonorgestrel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start25 Jan 2021
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missed Menstrual PeriodStudies 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
- Model description
- Simon's two-stage design
- Masking
- None (open label)
- Enrolment
- 139 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.
- Responsible party
- Sponsor
- Investigators
- Beverly H Winikoff, MD, Principal investigator, Gynuity Health ProjectsHolly A Anger, Study director, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676776
- Sponsor's protocol ID
- 8005
- Status last verified
- Aug 2021
- First submitted
- 15 Dec 2020
- Last updated
- 12 Aug 2021
- 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 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Use Of Mifepristone After Progestin Priming For Use As "Missed Period Pills"
- ClinicalTrials.gov ID
- NCT04676776
- Acronym / sponsor ID
- 8005
- Conditions
- Missed Menstrual Period
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Cuidado Integral de la Mujer, Gineclinic, S.C.
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 21 Dec 2020 (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.
This study will assess the effectiveness and acceptability of a 3-day missed period pill regimen.
Detailed description
Missed period pills (MPPs) are medications used for uterine evacuation among women with late menses who have not confirmed pregnancy status. Provision of MPPs could expand reproductive service options for individuals in a variety of settings. This study will collect data on the efficacy, safety, and acceptability of a 3-day missed period pill regimen among individuals with missed menses of 1-10 days
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Simon's two-stage design
| Arm | Type | Receives |
|---|---|---|
| Missed period pill regimen | Experimental | Drug: Levonorgestrel, Drug: Mifepristone1.5 mg levonorgestrel given on day 1 200 mg mifepristone given on day 3 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18-49 years
- General good health
- Does not want to be pregnant
- History of regular monthly menstrual cycles (±3 days)
- Missed menses of 1 to 10 days as verified by report of last menstrual period
Key exclusion criteria (3 listed)
- Known allergies or contraindications to mifepristone
- Symptoms of or risk factors for ectopic pregnancy, such as vaginal bleeding or spotting within the past week; unilateral pelvic pain or significant bilateral pelvic pain within the past week; prior ectopic pregnancy; prior permanent contraception or other tubal surgery
- 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 |
|---|---|---|
| LevonorgestrelAll participants receive 1.5 mg levonorgestrel on day 1 | Drug | Missed period pill regimen |
| MifepristoneAll participants receive 200 mg mifepristone on day 3 | Drug | Missed period pill regimen |
Primary outcome
Efficacy of missed period pill regimen
Time frame: Up to 28 days after administration of levonorgestrel
Proportion of participants not pregnant at follow-up among those who were pregnant at enrollment
4 secondary outcomes
Effectiveness of missed period pill regimen
Time frame: Up to 28 days after administration of levonorgestrel
Effectiveness at inducing return of menses within 10 days
Time frame: Up to 10 days after administration of levonorgestrel
Occurrence of treatment-emergent adverse events and/or side effects (safety and tolerability)
Time frame: Up to 28 days after administration of levonorgestrel
Acceptability of missed period pills
Time frame: Up to 28 days after administration of levonorgestrel
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
Related trials for Missed Menstrual Period
RecruitingPhase 4
Period Pills for Menstrual Regulation: A New Reproductive Health Option
Menstrual Regulation, Menstrual Health Intervention
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 H Winikoff, MD principal investigator
Gynuity Health Projects
Holly A Anger study director
Gynuity Health Projects
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 Levonorgestrel and Mifepristone in people with Missed Menstrual Period, run by Gynuity Health Projects at 1 site in Mexico.
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 12 Aug 2021. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Holly A Anger (2124481230, hanger@gynuity.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of missed period pill regimen (time frame: Up to 28 days after administration of levonorgestrel). 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 12 Aug 2021.