Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal Insert
NCT06668896 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-05-08
Summary
This study is looking for healthy female adults to use an vaginal ring with differing amounts of the hormone progesterone and go through a series of blood draws to measure how much progesterone is in the body following the use of these vaginal rings over an extended period of time.
Conditions
- Pre Term Birth
Interventions
- DRUG
-
Progesterone
Each arm will administer different amounts of progesterone vaginally (8mg to 100mg) over a 14-15 day time period.
Sponsors & Collaborators
-
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
collaborator NIH -
Daré Bioscience, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2027-11-30
- Completion
- 2028-04-30
- FDA Drug
- Yes
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