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Also known as 8% progesterone vaginal gel
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 therapy being studied in pregnancy, specifically to reduce the risk of another preterm birth. It is designed for vaginal administration in pregnant women. The clinical program is in Phase 3 development.
8% progesterone vaginal is being developed by Catalent, Inc., which trades under the ticker CTLT. Catalent is the sponsor associated with the clinical development program for this investigational therapy.
8% progesterone vaginal is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 trial has been completed, and no active trials are currently listed for this asset.
8% progesterone vaginal has been evaluated in one Phase 3 clinical trial, NCT00086177, titled Vaginal Progesterone to Reduce the Risk of Another Preterm Birth. The trial enrolled 636 participants in the United States, was randomized, double-blind, and placebo-controlled, and has been completed.
Yes, 8% progesterone vaginal gel is another name for 8% progesterone vaginal. Both refer to the same investigational product being developed by Catalent, Inc. for use in pregnancy.