New vaginal ring could make preterm birth prevention easier
NCT ID NCT06668896
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tests a new progesterone vaginal ring (8mg or 12mg daily) against a standard progesterone insert (100mg) in 60 healthy postmenopausal women. Researchers will measure how much progesterone gets into the blood over 14 days. The goal is to see if the ring delivers the hormone effectively, which could later be tested to prevent preterm birth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- progesterone
- What this could lead to
- If successful, this could lead to a more convenient progesterone delivery method to help prevent preterm birth.
- What could go wrong
- This is a very early Phase 1 study in healthy volunteers, not pregnant women. It only measures drug levels, not whether the ring prevents preterm birth. Many early-stage trials do not lead to approved treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Individuals assigned female at birth who are post-menopausal, women 40 to 65 years of age, inclusive. Postmenopausal is defined as 6-months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL (if not taking systemic hormone therapy) or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy. * Able and willing to correctly and independently complete all study procedures. * Able to read, understand, and provide written informed consent after the nature of the study has been fully explained and must be willing to comply with all study requirements and procedures. * VA vaginal pH of ≤ 5.0. Women with vaginal atrophy may rescreen at least 6 weeks after starting either systemic or topical estradiol therapy. * Women who are taking systemic (e.g. oral, injectable, transdermal) progesterone (P4) therapy must have at least 2 weeks of wash out from the last dose prior to visit 2. Exclusion Criteria: * Subjects with clinically significant chronic kidney disease defined as Glomerular Filtration Rate of \<60 mL/min/1.73m2 * Subjects with uninvestigated hematuria * Subjects with known nephrolithiasis, known polycystic kidney disease (PKD), or other known renal genetic disorders * Subjects with prior pelvic malignancies requiring radiation therapy, or whose surgery for such has led to complications such as fistulas, etc. * Subjects with a history of any severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or study treatment administration or could interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into the trial. This includes but is not limited to the following: * Active chronic hepatitis B or hepatitis C infection including hepatitis B surface antigen and hepatitis C antigen positive patients with or without abnormal liver enzymes * Concurrent neurodegenerative disease * Cardiovascular: uncontrolled hypertension, unstable angina, myocardial infarction or symptomatic congestive heart failure within the past 6 months or serious uncontrolled cardiac arrhythmia or use of Class 1 antiarrhythmic * Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol * Subjects with hypersensitivity toward any ingredients in the study treatments. * Participation in any other investigational drug or device trial in which administration of an investigational study drug/device occurred within 30 days or placement of a non-drug eluting medical device within 15 days prior to the Screening Visit (Visit 1). This does not include re-enrollments into this study, who require at least 14 days of washout prior to re-enrollment.
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As listed by the trial registrant
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How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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