Pregnancy, UnwantedPhase 1/2NCT03774745
Blocking Mifepristone Action With Progesterone
A Phase 1/2 study testing Mifepristone 200 MG and micronized Progesterone in people with Pregnancy, Unwanted, run by University of California, Davis at 3 sites in United States.
Trial summary
Double-blind randomized trial to evaluate the potential impact of progesterone treatment on early pregnancies exposed to mifepristone. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Unwanted
- What is being tested?
- Mifepristone 200 MG and micronized Progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Feb 2019to 15 Aug 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant females 18 years and older at enrollment.
- Seeking surgical abortion at 44-63 days' gestation on Study day 1.
- Have received counseling and signed informed consent per UCD standard procedures for surgical abortion.
- Presence of embryonic gestational cardiac activity on transvaginal ultrasonography.
- English-speaking
- Willing to sign informed consent and follow study protocol.
- Willing to experience potential expulsion of the pregnancy with mifepristone treatment.
Who cannot join
- Medical contraindications to medical abortion.
- Poorly controlled hypertension (systolic BP >160 or diastolic BP >95)
- Significant anemia - known recent hemoglobin <9.5 gm/dL
- Clinically significant cardiovascular disease (angina, valvular disease, arrhythmia, or congestive heart failure)
- Breastfeeding
- Coagulopathy or therapeutic coagulation
Show all 15Show fewer
- Ultrasound evidence of molar or ectopic pregnancy
- Chronic systemic corticosteroid use
- Adrenal disease
- Sickle cell anemia with frequent/recent crises
- Glaucoma
- IUD in place during conception, even if removed.
- Peanut allergy.
- Known intolerance of mifepristone or progesterone.
- Any other condition, that in the opinion of the clinician, would contraindicate mifepristone, progesterone or medical abortion.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Planned Parenthood Mar Monte
Sacramento, California, 95816
University of California, Davis
Sacramento, California, 95817
Family Planning Associates
Sacramento, California, 95825
About this study
Official title: A Randomized Trial of Mifepristone Antagonization With High-Dose Progesterone to Prevent Medical Abortion
Double-blind randomized trial to evaluate the potential impact of progesterone treatment on early pregnancies exposed to mifepristone.
Read the detailed description
Medical abortion commonly refers to early pregnancy termination (usually before 10 weeks' gestation) performed without primary surgical intervention and resulting from the use of abortion-inducing medications. The use of medications to cause abortion has been around for almost 70 years but the modern era of medical abortion treatment evolved with the development of mifepristone, a progesterone-receptor blocker with an affinity for the receptor greater than progesterone itself.
Medical abortion with mifepristone and misoprostol is highly effective; however, the risk of continuing pregnancy is still present, especially as gestation advances. While most women opt for further treatment in these scenarios, such as surgical aspiration, there are some who decide to continue the pregnancy. Thus, even following treatment, some women do change their mind.
No well-done study has evaluated whether such treatment works. Poorly controlled case series are not evidence and systematic reviews of continuing pregnancy rates after mifepristone/prostaglandin analogue treatment failure do not reflect real life outcomes. This study is also a first step to understanding if large studies evaluating mifepristone antagonization with high-dose progesterone are indicated and if placebo-controlled randomized trials can be successfully completed when evaluating this question.
- Conditions
- Pregnancy, Unwanted
- Being tested
- Mifepristone 200 MG, micronized Progesterone, Placebo oral capsule
- Keywords
- mifepristone, progesterone, abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone 200 MGDrug
Also called Mifeprex
All subjects receive mifepristone tablet on treatment day 1.
micronized ProgesteroneDrug
Also called Prometrium
Subjects randomized to progesterone receive treatment starting day 2.
Placebo oral capsuleDrug
Also called Placebo (for micronized progesterone)
Subjects randomized to placebo receive treatment starting day 2.
| Study group | Role | What they receive |
|---|---|---|
| Progesterone | Experimental | Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally. Receives: Drug: Mifepristone 200 MG; Drug: micronized Progesterone |
| Placebo oral capsule | Placebo comparator | Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally. Receives: Drug: Mifepristone 200 MG; Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuing Pregnancy Based on Ultrasound Examination
Pregnancy still in uterus with normal growth and gestational cardiac activity present based on ultrasound examination
Measured: at 14-16 days after mifepristone administration
Secondary outcomes (4)
Expulsion During Follow-up Evaluation
Pregnancy expulsion following mifepristone treatment
Measured: up to 16 days after mifepristone administration
Number of Participants With Adverse Events During Follow-up Evaluation
Side effects from progesterone/placebo treatment and ability to continued treatment as prescribed
Measured: up to 16 days after mifepristone administration
Medical Safety During Treatment and Follow-up
Adverse events related to morbidity, e.g. hemorrhage, emergency department visits, emergent dilation and curettage procedures
Measured: up to 16 days after mifepristone administration
Number of Participants With Change in Serum Progesterone and hCG During Follow-up
Change in serum progesterone and hCG during follow-up evaluation
Measured: up to 16 days after mifepristone administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start11 Feb 2019
- Primary completion29 Jul 2019
- Study completion15 Aug 2019
Why it stopped: Safety
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, UnwantedStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double blind, placebo controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Mitchell D Creinin, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774745
- Sponsor's protocol ID
- 1353650
- Status last verified
- Jan 2020
- First submitted
- 11 Dec 2018
- Last updated
- 22 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing de-identified data will be considered upon individual request
Publications
Creinin MD, Hou MY, Dalton L, Steward R, Chen MJ. Mifepristone Antagonization With Progesterone to Prevent Medical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2020 Jan;135(1):158-165. doi: 10.1097/AOG.0000000000003620.
PubMed 31809439
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Mifepristone Antagonization With High-Dose Progesterone to Prevent Medical Abortion
- ClinicalTrials.gov ID
- NCT03774745
- Acronym / sponsor ID
- 1353650
- Conditions
- Pregnancy, Unwanted
- Keywords
- mifepristone, progesterone, abortion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 13 Dec 2018 (actual)
- Results
- Posted 22 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double-blind randomized trial to evaluate the potential impact of progesterone treatment on early pregnancies exposed to mifepristone.
Detailed description
Medical abortion commonly refers to early pregnancy termination (usually before 10 weeks' gestation) performed without primary surgical intervention and resulting from the use of abortion-inducing medications. The use of medications to cause abortion has been around for almost 70 years but the modern era of medical abortion treatment evolved with the development of mifepristone, a progesterone-receptor blocker with an affinity for the receptor greater than progesterone itself.
Medical abortion with mifepristone and misoprostol is highly effective; however, the risk of continuing pregnancy is still present, especially as gestation advances. While most women opt for further treatment in these scenarios, such as surgical aspiration, there are some who decide to continue the pregnancy. Thus, even following treatment, some women do change their mind.
No well-done study has evaluated whether such treatment works. Poorly controlled case series are not evidence and systematic reviews of continuing pregnancy rates after mifepristone/prostaglandin analogue treatment failure do not reflect real life outcomes. This study is also a first step to understanding if large studies evaluating mifepristone antagonization with high-dose progesterone are indicated and if placebo-controlled randomized trials can be successfully completed when evaluating this question.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double blind, placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| Progesterone | Experimental | Drug: Mifepristone 200 MG, Drug: micronized ProgesteroneMicronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally. |
| Placebo oral capsule | Placebo comparator | Drug: Mifepristone 200 MG, Drug: Placebo oral capsulePlacebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pregnant females 18 years and older at enrollment.
- Seeking surgical abortion at 44-63 days' gestation on Study day 1.
- Have received counseling and signed informed consent per UCD standard procedures for surgical abortion.
- Presence of embryonic gestational cardiac activity on transvaginal ultrasonography.
- English-speaking
Key exclusion criteria (15 listed)
- Medical contraindications to medical abortion.
- IUD in place during conception, even if removed.
- Peanut allergy.
- Known intolerance of mifepristone or progesterone.
- Any other condition, that in the opinion of the clinician, would contraindicate mifepristone, progesterone or medical abortion.
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 |
|---|---|---|
| Mifepristone 200 MGAlso: MifeprexAll subjects receive mifepristone tablet on treatment day 1. | Drug | Placebo oral capsule, Progesterone |
| micronized ProgesteroneAlso: PrometriumSubjects randomized to progesterone receive treatment starting day 2. | Drug | Progesterone |
| Placebo oral capsuleAlso: Placebo (for micronized progesterone)Subjects randomized to placebo receive treatment starting day 2. | Drug | Placebo oral capsule |
Primary outcome
Continuing Pregnancy Based on Ultrasound Examination
Time frame: at 14-16 days after mifepristone administration
Pregnancy still in uterus with normal growth and gestational cardiac activity present based on ultrasound examination
4 secondary outcomes
Expulsion During Follow-up Evaluation
Time frame: up to 16 days after mifepristone administration
Number of Participants With Adverse Events During Follow-up Evaluation
Time frame: up to 16 days after mifepristone administration
Medical Safety During Treatment and Follow-up
Time frame: up to 16 days after mifepristone administration
Number of Participants With Change in Serum Progesterone and hCG During Follow-up
Time frame: up to 16 days after mifepristone administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31809439Creinin MD, Hou MY, Dalton L, Steward R, Chen MJ. Mifepristone Antagonization With Progesterone to Prevent Medical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2020 Jan;135(1):158-165. doi: 10.1097/AOG.0000000000003620.
- Individual participant dataSharing planned: No. Sharing de-identified data will be considered upon individual request
Related trials for Pregnancy, Unwanted
Not yet recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
Not yet recruiting
#TranscendentHealth: A Text Messaging Pregnancy Prevention Program for Transgender Boys
Pregnancy (Unwanted), Sexually Transmitted Disease (STD)
Active, not recruitingObservational study
Consequences of Unwanted Pregnancy in Nepal
Unwanted Pregnancy
Not yet recruiting
The Effect of Mindfulness Compassionate Living Training on Unwanted Pregnancies
Mindfulness Compassionate Living Training
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.
Mitchell D Creinin, MD principal investigator
University of California, Davis
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mifepristone 200 MG and micronized Progesterone in people with Pregnancy, Unwanted, run by University of California, Davis at 3 sites 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 7 inclusion and 15 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: stopped early, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 22 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Continuing Pregnancy Based on Ultrasound Examination (time frame: at 14-16 days after mifepristone administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03774745, which also lists 1 linked publication.
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 22 Jan 2020.