Methamphetamine-dependenceEarly Phase 1NCT05128071
PRevention Of Methamphetamine Use Among Postpartum Women Trial (PROMPT)
A Early Phase 1 study testing Progesterone in people with Methamphetamine-dependence and Postpartum Abstinence, run by University of Utah at 1 site in United States.
Trial summary
The PRevention Of Methamphetamine Use among Postpartum Women Trial (PROMPT) is randomized controlled trial of postpartum individuals with methamphetamine use disorder to 12 weeks of 200 mg oral micronized progesterone twice daily or placebo. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Methamphetamine-dependence, Postpartum Abstinence
- What is being tested?
- Progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2022to 30 May 2024
- Phase
- Early Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meeting criteria for substance use disorder of methamphetamine in the six months prior to conception or during pregnancy
- No active methamphetamine use at time of enrollment or within past 4 weeks prior to enrollment by self-report or urine toxicology.
- If diagnosis of active opioid use disorder (OUD) and no use at time of enrollment or within past 4 weeks prior to enrollment by self-report or urine toxicology and on stable dose of medication for OUD (methadone, buprenorphine, naltrexone) for two weeks prior to enrollment in order to allow for postpartum dose adjustments.
- Intrauterine device or barrier method for contraception during the study period
- End of pregnancy within past 12 weeks
- Residing within 100 miles of study site
- Stable on allowable psychiatric medications including selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and mood stabilizers for four weeks prior to enrollment
Who cannot join
- Major medical illness in which progesterone may be contraindicated (significant liver disease, history of thrombophlebitis, stroke, heart disease, suspected or known malignancy, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders)
- Any of the following laboratory abnormalities (within 2 weeks of screening and enrollment)
- Active hepatic dysfunction
- Anemia defined as hemoglobin less than 8 g/dL indicating anemia
- Renal impairment defined as creatinine greater than 2.0 mg/dL
- Hypothyroidism defined as TSH greater than 5 mIU/L
Show all 18Show fewer
- Abnormal vital signs at baseline visit
- Allergy to micronized progesterone or ingredients in placebo including peanut oil, gelatin or cellulose
- Self-reported progestin-containing oral or depot containing contraceptives intolerance.
- Do not speak English or Spanish
- Taking potent inhibitors of CY P450 3A4 including clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil and goldenseal.
- Severe depressive symptoms
- Active suicidality
- Current or past history of psychosis, suicidal attempts or psychiatric hospitalizations
- Current or pending incarceration
- Active alcohol use disorder within past six months
- Use of the following concomitant drugs, supplements and over-the-counter medications in the two week prior to enrollment: stimulants, barbiturates, benzodiazepines, non-benzodiazepine hypnotics, orexin antagonists, first generation anti-histamine, herbal sedatives, methaqualone and analogues, skeletal muscle relaxants, opioids (other than methadone or buprenorphine), anti-psychotic medications, certain anti-depressants or other medication with significant sedative properties as evaluated by the PI and/or study clinician.
- Progestin containing medications including oral hormonal contraceptive methods
Trial locations and contacts
1 site in 1 country.
About this study
The PRevention Of Methamphetamine Use among Postpartum Women Trial (PROMPT) is randomized controlled trial of postpartum individuals with methamphetamine use disorder to 12 weeks of 200 mg oral micronized progesterone twice daily or placebo. The aims of this study are to assess the feasibility, safety and preliminary efficacy of micronized progesterone for the prevention of return to methamphetamine use. A secondary aim is to assess participant's salivary levels of allopregnanolone with methamphetamine cravings. This study has the potential to provide effective interventions to prevent methamphetamine use among postpartum women.
Read the detailed description
While substantial attention and resources have been directed at the opioid epidemic in the US, another deadly drug epidemic - methamphetamine use (MU) - has been evolving. While most pregnant women achieve abstinence by late pregnancy, the postpartum period is a particularly vulnerable time. Postpartum return to use is high and potentially deadly. Data from the Utah Maternal Mortality Review Committee indicate that from 2005-2016 (n=176), MU contributed to one out of every five deaths of pregnant and postpartum women; 85% of these deaths occurred in the postpartum period and, 70% of methamphetamine-related deaths also involved opioids. While medications for OUD reduce return to opioid use among postpartum women, similar interventions to reduce return to MU are lacking.
In developing novel interventions to address MU in this vulnerable population, it is critical to consider important hormonal changes that mediate drug cravings and place postpartum women at particular risk of return to MU. Among women, higher systemic levels of progesterone and its active metabolite allopregnanolone appear to attenuate drug craving, urges, and return to use. Postpartum women may be particularly sensitive to increased craving and urges given the precipitous post-delivery drop in endogenous progesterone and allopregnanolone levels. Supplementation of exogenous progesterone is a novel therapy that has shown promising results in decreasing return to use among women using cocaine, tobacco, and benzodiazepines. Among postpartum women who used cocaine in pregnancy, micronized progesterone (which metabolizes to allopregnanolone) was associated with a reduction in cocaine use in the first 12 weeks postpartum in a randomized, placebo-controlled trial.
The investigator's long-term goal is to advance the understanding of how pregnant and postpartum women's unique physiology impacts the trajectory of MUD and to apply this knowledge to developing novel interventions aimed at reducing MU in this population. The objectives of the PROMPT study is to determine: 1) the effect of micronized progesterone on return to MU among postpartum women with MUD, and, 2) determine the association between allopregnanolone levels and methamphetamine craving in this population. The central hypothesis is that micronized progesterone is a feasible, safe, and effective intervention that reduces the risk of return to MU among postpartum women with methamphetamine use disorder
- Conditions
- Methamphetamine-dependence, Postpartum Abstinence
- Being tested
- Progesterone, Placebo
- Keywords
- Pregnancy, Postpartum
- Medical subject headings
- Sexual Abstinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Randomized to 400 mg (200 mg twice daily) oral micronized progesterone daily
PlaceboDrug
Randomized to placebo twice daily
| Study group | Role | What they receive |
|---|---|---|
| Progesterone Arm | Active comparator | Randomized to receive progesterone Receives: Drug: Progesterone |
| Placebo Arm | Placebo comparator | Randomized to receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Recruitment and Randomization of 40 Postpartum Women Into the PROMPT Study
Recruit and enroll 40 eligible women (postpartum individuals with MUD) in a 15 month period from time of study initiation.
Measured: 15 months after study initiation
Secondary outcomes (5)
Number of Participants With Severe Medication Side Effects
Number of enolled participants with Severe Medication Side Effects
Measured: Baseline and 12 weeks
Assess Depression and Suicidality Status in Enrolled Participants
A lower score on the Edinburgh Postpartum Depression Scale (EPDS) scale indicates a better outcome.
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item screening tool (maximum score 30) used to identify perinatal depression, where scores 0-9 indicate minimal depression, scores of 10 or higher typically indicate possible depression, and scores of 13 or greater strongly suggest a depressive illness.
Measured: Baseline and 12 weeks
Assess Anxiety Status in Enrolled Participants
Assess anxiety status in enrolled participants using validated surveys/ GAD-7
The GAD-7 (Generalized Anxiety Disorder-7) is a 7-item, self-reported questionnaire used to measure anxiety severity over the past two weeks. Scores range from 0 to 21, categorized as mild (0-4), moderate (5-9), moderately severe (10-14), and severe (15-21) anxiety. A score of 10 or higher is the typical cutoff for identifying clinical anxiety
Measured: Baseline and 12 weeks
Difference in Tobacco Use From Baseline
Secondarily we assessed the association between the exposures of doses of progesterone administered and tobacco use.
Measured: Baseline and 12 weeks
Assess Return to Methamphetamine Use (MU) in Enrolled Participants
Assess the efficacy of micronized progesterone to decrease return to methamphetamine use (MU) among postpartum women with methamphetamine use disorder. Return to use will be defined as either self-reported MU or positive urine toxicology result. Results will be compared between placebo and active ingredient groups.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start4 Feb 2022
- Primary completion30 May 2024
- Study completion30 May 2024
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 (11)Papers the sponsor has linked to this study.
- Other trials for Methamphetamine-dependenceStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcela Smid, University of Utah
- Investigators
- Marcela Smid, MD, Principal investigator, University of Utha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128071
- Sponsor's protocol ID
- 138663
- Status last verified
- May 2026
- First submitted
- 9 Sep 2021
- Last updated
- 3 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Forray A, Merry B, Lin H, Ruger JP, Yonkers KA. Perinatal substance use: a prospective evaluation of abstinence and relapse. Drug Alcohol Depend. 2015 May 1;150:147-55. doi: 10.1016/j.drugalcdep.2015.02.027. Epub 2015 Mar 3.
PubMed 25772437Smid MC, Stone NM, Baksh L, Debbink MP, Einerson BD, Varner MW, Gordon AJ, Clark EAS. Pregnancy-Associated Death in Utah: Contribution of Drug-Induced Deaths. Obstet Gynecol. 2019 Jun;133(6):1131-1140. doi: 10.1097/AOG.0000000000003279.
PubMed 31135726Jones HE, Kaltenbach K, Heil SH, Stine SM, Coyle MG, Arria AM, O'Grady KE, Selby P, Martin PR, Fischer G. Neonatal abstinence syndrome after methadone or buprenorphine exposure. N Engl J Med. 2010 Dec 9;363(24):2320-31. doi: 10.1056/NEJMoa1005359.
PubMed 21142534Wiegand SL, Stringer EM, Stuebe AM, Jones H, Seashore C, Thorp J. Buprenorphine and naloxone compared with methadone treatment in pregnancy. Obstet Gynecol. 2015 Feb;125(2):363-368. doi: 10.1097/AOG.0000000000000640.
PubMed 25569005Yonkers KA, Forray A, Nich C, Carroll KM, Hine C, Merry BC, Shaw H, Shaw J, Sofuoglu M. Progesterone Reduces Cocaine Use in Postpartum Women with a Cocaine Use Disorder: A Randomized,Double-Blind Study. Lancet Psychiatry. 2014 Oct 1;1(5):360-367. doi: 10.1016/S2215-0366(14)70333-5.
PubMed 25328863Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2. doi: 10.1590/s2317-17822013000200017. No abstract available.
PubMed 24413388Ellis MS, Kasper ZA, Cicero TJ. Twin epidemics: The surging rise of methamphetamine use in chronic opioid users. Drug Alcohol Depend. 2018 Dec 1;193:14-20. doi: 10.1016/j.drugalcdep.2018.08.029. Epub 2018 Oct 10.
PubMed 30326396Kuo CJ, Liao YT, Chen WJ, Tsai SY, Lin SK, Chen CC. Causes of death of patients with methamphetamine dependence: a record-linkage study. Drug Alcohol Rev. 2011 Nov;30(6):621-8. doi: 10.1111/j.1465-3362.2010.00255.x. Epub 2010 Oct 18.
PubMed 21355920Chen LH, Hedegaard H, Warner M. Drug-poisoning Deaths Involving Opioid Analgesics: United States, 1999-2011. NCHS Data Brief. 2014 Sep;(166):1-8.
PubMed 25228059Hedegaard H, Minino AM, Warner M. Drug Overdose Deaths in the United States, 1999-2018. NCHS Data Brief. 2020 Jan;(356):1-8.
PubMed 32487285Smid MC, Charles JE, Allshouse AA, Castro S, Humiston GE, Cash E, Turner E, Carlston K, Gibson M, Gordon AJ, Cochran GT. Prevention of postpartum methamphetamine use with micronized progesterone trial (PROMPT): A pilot randomized controlled trial. Drug Alcohol Depend. 2026 Aug 27;287:113325. doi: 10.1016/j.drugalcdep.2026.113325. Online ahead of print.
PubMed 42673669
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRevention Of Methamphetamine Use Among Postpartum Women Trial (PROMPT)
- ClinicalTrials.gov ID
- NCT05128071
- Acronym / sponsor ID
- 138663
- Conditions
- Methamphetamine-dependence, Postpartum Abstinence
- Keywords
- Pregnancy, Postpartum
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Posted 3 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PRevention Of Methamphetamine Use among Postpartum Women Trial (PROMPT) is randomized controlled trial of postpartum individuals with methamphetamine use disorder to 12 weeks of 200 mg oral micronized progesterone twice daily or placebo. The aims of this study are to assess the feasibility, safety and preliminary efficacy of micronized progesterone for the prevention of return to methamphetamine use. A secondary aim is to assess participant's salivary levels of allopregnanolone with methamphetamine cravings. This study has the potential to provide effective interventions to prevent methamphetamine use among postpartum women.
Detailed description
While substantial attention and resources have been directed at the opioid epidemic in the US, another deadly drug epidemic - methamphetamine use (MU) - has been evolving. While most pregnant women achieve abstinence by late pregnancy, the postpartum period is a particularly vulnerable time. Postpartum return to use is high and potentially deadly. Data from the Utah Maternal Mortality Review Committee indicate that from 2005-2016 (n=176), MU contributed to one out of every five deaths of pregnant and postpartum women; 85% of these deaths occurred in the postpartum period and, 70% of methamphetamine-related deaths also involved opioids. While medications for OUD reduce return to opioid use among postpartum women, similar interventions to reduce return to MU are lacking.
In developing novel interventions to address MU in this vulnerable population, it is critical to consider important hormonal changes that mediate drug cravings and place postpartum women at particular risk of return to MU. Among women, higher systemic levels of progesterone and its active metabolite allopregnanolone appear to attenuate drug craving, urges, and return to use. Postpartum women may be particularly sensitive to increased craving and urges given the precipitous post-delivery drop in endogenous progesterone and allopregnanolone levels. Supplementation of exogenous progesterone is a novel therapy that has shown promising results in decreasing return to use among women using cocaine, tobacco, and benzodiazepines. Among postpartum women who used cocaine in pregnancy, micronized progesterone (which metabolizes to allopregnanolone) was associated with a reduction in cocaine use in the first 12 weeks postpartum in a randomized, placebo-controlled trial.
The investigator's long-term goal is to advance the understanding of how pregnant and postpartum women's unique physiology impacts the trajectory of MUD and to apply this knowledge to developing novel interventions aimed at reducing MU in this population. The objectives of the PROMPT study is to determine: 1) the effect of micronized progesterone on return to MU among postpartum women with MUD, and, 2) determine the association between allopregnanolone levels and methamphetamine craving in this population. The central hypothesis is that micronized progesterone is a feasible, safe, and effective intervention that reduces the risk of return to MU among postpartum women with methamphetamine use disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progesterone Arm | Active comparator | Drug: ProgesteroneRandomized to receive progesterone |
| Placebo Arm | Placebo comparator | Drug: PlaceboRandomized to receive placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Meeting criteria for substance use disorder of methamphetamine in the six months prior to conception or during pregnancy
- No active methamphetamine use at time of enrollment or within past 4 weeks prior to enrollment by self-report or urine toxicology.
- If diagnosis of active opioid use disorder (OUD) and no use at time of enrollment or within past 4 weeks prior to enrollment by self-report or urine toxicology and on stable dose of medication for OUD (methadone, buprenorphine, naltrexone) for two weeks prior to enrollment in order to allow for postpartum dose adjustments.
- Intrauterine device or barrier method for contraception during the study period
- End of pregnancy within past 12 weeks
Key exclusion criteria (18 listed)
- Major medical illness in which progesterone may be contraindicated (significant liver disease, history of thrombophlebitis, stroke, heart disease, suspected or known malignancy, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders)
- Any of the following laboratory abnormalities (within 2 weeks of screening and enrollment)
- Active hepatic dysfunction
- Anemia defined as hemoglobin less than 8 g/dL indicating anemia
- Renal impairment defined as creatinine greater than 2.0 mg/dL
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 |
|---|---|---|
| ProgesteroneRandomized to 400 mg (200 mg twice daily) oral micronized progesterone daily | Drug | Progesterone Arm |
| PlaceboRandomized to placebo twice daily | Drug | Placebo Arm |
Primary outcome
Successful Recruitment and Randomization of 40 Postpartum Women Into the PROMPT Study
Time frame: 15 months after study initiation
Recruit and enroll 40 eligible women (postpartum individuals with MUD) in a 15 month period from time of study initiation.
5 secondary outcomes
Number of Participants With Severe Medication Side Effects
Time frame: Baseline and 12 weeks
Assess Depression and Suicidality Status in Enrolled Participants
Time frame: Baseline and 12 weeks
Assess Anxiety Status in Enrolled Participants
Time frame: Baseline and 12 weeks
Difference in Tobacco Use From Baseline
Time frame: Baseline and 12 weeks
Assess Return to Methamphetamine Use (MU) in Enrolled Participants
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25772437Forray A, Merry B, Lin H, Ruger JP, Yonkers KA. Perinatal substance use: a prospective evaluation of abstinence and relapse. Drug Alcohol Depend. 2015 May 1;150:147-55. doi: 10.1016/j.drugalcdep.2015.02.027. Epub 2015 Mar 3.
- Background: PubMed 31135726Smid MC, Stone NM, Baksh L, Debbink MP, Einerson BD, Varner MW, Gordon AJ, Clark EAS. Pregnancy-Associated Death in Utah: Contribution of Drug-Induced Deaths. Obstet Gynecol. 2019 Jun;133(6):1131-1140. doi: 10.1097/AOG.0000000000003279.
- Background: PubMed 21142534Jones HE, Kaltenbach K, Heil SH, Stine SM, Coyle MG, Arria AM, O'Grady KE, Selby P, Martin PR, Fischer G. Neonatal abstinence syndrome after methadone or buprenorphine exposure. N Engl J Med. 2010 Dec 9;363(24):2320-31. doi: 10.1056/NEJMoa1005359.
- Background: PubMed 25569005Wiegand SL, Stringer EM, Stuebe AM, Jones H, Seashore C, Thorp J. Buprenorphine and naloxone compared with methadone treatment in pregnancy. Obstet Gynecol. 2015 Feb;125(2):363-368. doi: 10.1097/AOG.0000000000000640.
- Background: PubMed 25328863Yonkers KA, Forray A, Nich C, Carroll KM, Hine C, Merry BC, Shaw H, Shaw J, Sofuoglu M. Progesterone Reduces Cocaine Use in Postpartum Women with a Cocaine Use Disorder: A Randomized,Double-Blind Study. Lancet Psychiatry. 2014 Oct 1;1(5):360-367. doi: 10.1016/S2215-0366(14)70333-5.
- Background: PubMed 24413388Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2. doi: 10.1590/s2317-17822013000200017. No abstract available.
- Background: PubMed 30326396Ellis MS, Kasper ZA, Cicero TJ. Twin epidemics: The surging rise of methamphetamine use in chronic opioid users. Drug Alcohol Depend. 2018 Dec 1;193:14-20. doi: 10.1016/j.drugalcdep.2018.08.029. Epub 2018 Oct 10.
- Background: PubMed 21355920Kuo CJ, Liao YT, Chen WJ, Tsai SY, Lin SK, Chen CC. Causes of death of patients with methamphetamine dependence: a record-linkage study. Drug Alcohol Rev. 2011 Nov;30(6):621-8. doi: 10.1111/j.1465-3362.2010.00255.x. Epub 2010 Oct 18.
- Background: PubMed 25228059Chen LH, Hedegaard H, Warner M. Drug-poisoning Deaths Involving Opioid Analgesics: United States, 1999-2011. NCHS Data Brief. 2014 Sep;(166):1-8.
- Background: PubMed 32487285Hedegaard H, Minino AM, Warner M. Drug Overdose Deaths in the United States, 1999-2018. NCHS Data Brief. 2020 Jan;(356):1-8.
- Derived from this study: PubMed 42673669Smid MC, Charles JE, Allshouse AA, Castro S, Humiston GE, Cash E, Turner E, Carlston K, Gibson M, Gordon AJ, Cochran GT. Prevention of postpartum methamphetamine use with micronized progesterone trial (PROMPT): A pilot randomized controlled trial. Drug Alcohol Depend. 2026 Aug 27;287:113325. doi: 10.1016/j.drugalcdep.2026.113325. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Marcela Smid, MD principal investigator
University of Utha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Progesterone in people with Methamphetamine-dependence and Postpartum Abstinence, run by University of Utah 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 7 inclusion and 18 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 3 Jun 2026. 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. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 3 Jun 2026). 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?
Successful Recruitment and Randomization of 40 Postpartum Women Into the PROMPT Study (time frame: 15 months after study initiation). 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 NCT05128071, which also lists 11 linked publications.
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 3 Jun 2026.