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New treatment option for Hyperemesis Gravidarum
Official title Hyperemesis Gravidarum Risk Reduction With Metformin
ClinicalTrials.gov ID: NCT07129473
What this study is testing
What is Metformin Extended Release Oral Tablet?
Metformin Extended Release Oral Tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hyperemesis gravidarum.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate whether daily oral metformin extended-release (metformin-XR), taken prior to and in early pregnancy, can reduce the risk and severity of Hyperemesis Gravidarum (HG), a severe nausea and vomiting condition in pregnancy, in individuals aged 18-49 who have experienced HG in a previous pregnancy and are trying to conceive. Researchers also aim to better understand which individuals may respond well - or poorly - to metformin based on biological and clinical characteristics.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 49, women only. Healthy volunteers may be eligible.
You may be able to join if
- Ages 18-49
- HG in prior pregnancy (clinical criteria: intravenous (IV) fluid treatment)
- Trying to conceive
- Treatment Arm: willing to refrain from trying to conceive during their metformin dose titration period and before 2 weeks at maximum tolerated dose...
- Under care of a personal OB/GYN or willing to establish care with a personal OB/GYN before study start
You likely can't join if
- Allergic or adverse reaction to metformin-XR
- Thalassemia
- Cirrhosis and/or hepatic impairment
- Decompensated heart failure
- Daily/regular use of medications/substances (tobacco, cyclobenzaprine, cannabis, escitalopram, sertraline, other SSRIs, Lasix)
- Treatment Arm: Use of insulin, sulfonylureas, meglitinides, or other blood sugar altering medication
See the full eligibility criteria
- Ages 18-49
- HG in prior pregnancy (clinical criteria: intravenous (IV) fluid treatment)
- Trying to conceive
- Treatment Arm: willing to refrain from trying to conceive during their metformin dose titration period and before 2 weeks at maximum tolerated dose (up to 8 weeks total). Will use birth control or contraceptive device...
- Under care of a personal OB/GYN or willing to establish care with a personal OB/GYN before study start
- Ownership of a personal scale (or willingness to obtain one for study use)
- Willing to participate in a trial that includes daily use of an oral agent prior to pregnancy
- Treatment Arm: residing in California/Alabama
- Treatment Arm: normal blood panel (CBC) (e.g., white count, hemoglobin, platelets all within the normal range)
- Treatment Arm: normal to mildly decreased creatinine levels (estimated GFR \> 60 mL/min/1.73m²)
- Survey/Comparator Arm: not currently taking metformin and do not plan to take metformin prior to pregnancy
- Able and willing to provide written informed consent prior to initiation of any study procedures.
- Demonstrates understanding of the study objectives, requirements, potential risks, and willingness to comply with study procedures and follow-up.
- English speaking
- Regular cycles
- Allergic or adverse reaction to metformin-XR
- Thalassemia
- Cirrhosis and/or hepatic impairment
- Decompensated heart failure
- Daily/regular use of medications/substances (tobacco, cyclobenzaprine, cannabis, escitalopram, sertraline, other SSRIs, Lasix)
- Treatment Arm: Use of insulin, sulfonylureas, meglitinides, or other blood sugar altering medication
- Assisted Reproductive Technology
- Excess alcohol consumption (\> 7 standard drinks per week on average)
- Pregnant
- Not trying to conceive
- Treatment Arm: Residing outside California/Alabama
- Treatment Arm: abnormal blood panel (CBC) (e.g., white count or platelets not within the normal range)
- Treatment Arm: abnormal creatinine levels (estimated GFR \< 60 mL/min/1.73m² excluded from the study, signs of kidney disease)
- Treatment Arm: current metformin use
- Survey/Comparator Arm: current metformin use or plans to take metformin prior to pregnancy
- Any medical/surgical condition that the investigator feels would compromise the participant's participation in the study
- Not able and willing to provide written informed consent prior to initiation of any study procedures.
- Does not demonstrate understanding of the study objectives, requirements, potential risks, and willingness to comply with study procedures and follow-up.
- Not english speaking
- Irregular cycles
- Not willing to refrain from trying to conceive/use birth control or contraceptive device until maintenance dose.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 49 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.