Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R44HD101169-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DARE-PTB1 8mg IVR | Experimental | Intravaginal ring containing 8mg progesterone administered once for 14 days. |
|
| DARE-PTB1 12mg IVR | Experimental | Intravaginal ring containing 12mg progesterone administered once for 14 days. |
|
| DARE-PTB1 12mg IVR every 3 days | Experimental | Intravaginal ring containing 12mg progesterone administered every 3 days for 15 days. |
|
| Endometrin 100mg | Active Comparator | 100mg progesterone vaginal insert, three times daily for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone | Drug | Each arm will administer different amounts of progesterone vaginally (8mg to 100mg) over a 14-15 day time period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days |
Not provided
Not provided
Inclusion Criteria:
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:
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.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Thurman, MD | Contact | 210-380-5241 | athurman@darebioscience.com | |
| Jessica Hatheway, MBA | Contact | 3173792115 | jhatheway@darebioscience.com |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |