Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal Insert
ConditionPre Term Birth
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorDaré Bioscience, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Progesterone
Treatment groups
60 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Daré Bioscience, Inc.
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov