Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
progesterone · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | placebo vaginal gel |
| Prochieve | ACTIVE_COMPARATOR | Progesterone 8% Vaginal Gel |
| Name | Type | Description |
|---|---|---|
| progesterone | DRUG | 8% vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation |
| placebo | DRUG | vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation |
Inclusion Criteria: 1. The subject has a short cervical length by transvaginal ultrasound (TVU) defined as 10-20mm. In cases of "dynamic cervix", the shortest observed/documented cervical length by TVU is to be used as the cervical length for inclusion purposes. 2. Singleton gestation. 3. The pregn...
Progesterone is a small molecule being studied for the prevention of preterm delivery in pregnant women with a short cervix. It is currently in Phase 3 clinical development as an investigational therapy. The drug is being evaluated in a randomized, double-blind, placebo-controlled trial to assess its effectiveness in this condition.
Catalent, Inc. (NASDAQ: CTLT) is the developer of progesterone for the prevention of preterm delivery. The company is conducting clinical research on this small molecule therapy, which is currently in Phase 3 development for the indication of preterm delivery in women with a short cervix.
Progesterone is in Phase 3 clinical development for the prevention of preterm delivery. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform potential regulatory submissions for this indication.
Progesterone is being studied in the PREGNANT Short Cervix Trial, registered as NCT00615550. This Phase 3, randomized, double-blind, placebo-controlled trial enrolled 465 women with a short cervix at risk for preterm delivery. The study was conducted across multiple countries, including the United States, Belarus, Chile, Czechia, India, Israel, Italy, Russia, South Africa, and Ukraine.
Yes, progesterone is the drug evaluated in the PREGNANT Short Cervix Trial (NCT00615550). This Phase 3 study tested progesterone in pregnant women with a short uterine cervical length to prevent preterm delivery. The trial was completed and included 465 participants, with results expected to support the drug's development for this indication.