An Open-Label, Four-Treatment, Parallel Study of the Comparative Pharmacokinetics of a Progesterone Intravaginal Ring (IVR) 8 mg and 12 mg/Day Versus Progesterone Vaginal Insert 100mg

Daré Bioscience, Inc.0 sites60 target enrollmentNovember 1, 2025

ConditionsPre Term Birth

InterventionsProgesterone

DrugsProgesterone

Overview

Phase: Phase 1
Intervention: Progesterone
Conditions: Pre Term Birth
Sponsor: Daré Bioscience, Inc.
Enrollment: 60
Primary Endpoint: Systemic pharmacokinetics of progesterone, Concentration over 24 hours
Status: Not yet recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 1, 2025

End Date

June 1, 2026

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Daré Bioscience, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.
•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.