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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Progesterone
Drug
Each arm will administer different amounts of progesterone vaginally (8mg to 100mg) over a 14-15 day time period.

Treatment groups

60 Participants

are divided into 4 treatment groups

Group A: DARE-PTB1 8mg IVRExperimental treatment 1 intervention

Group B: DARE-PTB1 12mg IVRExperimental treatment 1 intervention

Group C: DARE-PTB1 12mg IVR every 3 daysExperimental treatment 1 intervention

Group D: Endometrin 100mgActive comparator 1 intervention

Trial outcomes

Primary outcomes

Systemic pharmacokinetics of progesterone, Concentration over 24 hours

Describe the concentration of progesterone (P4) in blood prior to, during and after 24 hours of DARE-PTB1 IVR (8mg and 12mg) over 14 days of use.

Time frame

14 days

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daré Bioscience, Inc.

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: