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8% progesterone vaginal · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Progesterone 8% vaginal gel |
| 2 | PLACEBO_COMPARATOR | Placebo Vaginal Gel |
| Name | Type | Description |
|---|---|---|
| 8% progesterone vaginal gel | DRUG | Progesterone 8% Vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation |
| Placebo Vaginal Gel | DRUG | Placebo vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation |
Inclusion Criteria: 1. The subject has a history of a documented spontaneous singleton preterm delivery (hospital or clinic record, letter from healthcare provider, or birth certificate) from 20 0/7 to 35 0/7 weeks gestational age with the immediate preceding pregnancy or has a cervical length of 2...
8% progesterone vaginal is an investigational small molecule being studied for use in pregnancy. It is a vaginal progesterone formulation intended to reduce the risk of another preterm birth in pregnant women. The drug is currently in Phase 3 clinical development and is not yet approved by the FDA.
8% progesterone vaginal is being developed by Catalent, Inc. (ticker: CTLT). The company is conducting clinical trials to evaluate the drug's safety and efficacy in pregnant women at risk of preterm birth.
8% progesterone vaginal is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still undergoing clinical trials to assess its safety and effectiveness for reducing the risk of preterm birth in pregnant women.
8% progesterone vaginal has one completed Phase 3 clinical trial, NCT00086177, titled "Vaginal Progesterone to Reduce the Risk of Another Preterm Birth." The trial enrolled 636 pregnant women in the United States and was randomized, double-blind, and placebo-controlled.
8% progesterone vaginal is a specific formulation of progesterone, a naturally occurring hormone, delivered vaginally at an 8% concentration. It is being studied for its ability to reduce the risk of preterm birth in pregnant women with a history of prior preterm birth.