Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal Insert

NCT ID: NCT06668896

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2026-06-30

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.

Conditions

Pre Term Birth

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DARE-PTB1 8mg IVR

Intravaginal ring containing 8mg progesterone administered once for 14 days.

Group Type: EXPERIMENTAL

Progesterone

Intervention Type: DRUG

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

DARE-PTB1 12mg IVR

Intravaginal ring containing 12mg progesterone administered once for 14 days.

Group Type: EXPERIMENTAL

Progesterone

Intervention Type: DRUG

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

DARE-PTB1 12mg IVR every 3 days

Intravaginal ring containing 12mg progesterone administered every 3 days for 15 days.

Group Type: EXPERIMENTAL

Progesterone

Intervention Type: DRUG

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

Endometrin 100mg

100mg progesterone vaginal insert, three times daily for 14 days.

Group Type: ACTIVE_COMPARATOR

Progesterone

Intervention Type: DRUG

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

Interventions

Progesterone

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

Intervention Type: DRUG

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 ≤ 5.0. 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Daré Bioscience, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Andrea Thurman, MD

Role: CONTACT

athurman@darebioscience.com

210-380-5241

Jessica Hatheway, MBA

Role: CONTACT

jhatheway@darebioscience.com

3173792115

Other Identifiers

1R44HD101169-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DARE-PTB1-001

Identifier Type: -

Identifier Source: org_study_id