Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Progesterone · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Progesterone | DRUG | Each arm will administer different amounts of progesterone vaginally (8mg to 100mg) over a 14-15 day time period. |
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 o...
Progesterone is being developed by Dare Bioscience, Inc. for the prevention of Pre Term Birth. It is a small molecule drug currently in Phase 1 clinical development. The drug is being studied in a clinical trial to compare the pharmacokinetics of a progesterone ring versus a progesterone vaginal insert in women at risk of preterm birth.
Progesterone is being developed by Dare Bioscience, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol DARE. The company is conducting clinical trials to evaluate the drug for the prevention of Pre Term Birth.
Progesterone is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is designed to compare the pharmacokinetics of a progesterone ring versus a progesterone vaginal insert.
Progesterone is being studied in a Phase 1 clinical trial with the identifier NCT06668896. The trial, titled "Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal Insert," is not yet recruiting and plans to enroll 60 female participants aged 40 years and older.
Progesterone is the active drug being studied in two different formulations: a progesterone ring and a progesterone vaginal insert. The ongoing Phase 1 trial compares the pharmacokinetics of these two delivery methods to evaluate how the drug is absorbed and processed in the body.