Vaginal Progesterone to Reduce the Risk of Another Preterm Birth
Juniper Pharmaceuticals, Inc.
This research study is being conducted at over 12 pregnancy research centers in the US. The
study will compare an investigational treatment with a placebo (a treatment without
medication). Neither the investigators nor the patients in the trial will know which
treatment has been assigned. All study medications will be given vaginally once a day.
Treatment will begin before pregnancy week 23 and will continue until the end of pregnancy
Multi-Center, Randomized, Open-Label, Parallel Group Study of a Vaginal Micronized Progesterone Tablet (Endometrin®) Compared to Crinone 8% Vaginal Gel in Female Patients Undergoing In-Vitro Fertilization (IVF)
This multicenter, randomized, open-label study will be performed in approximately 990 healthy
females undergoing IVF. Each study center will follow their study center standard practice
for IVF unless otherwise noted in this protocol. The study centers will be provided with the
medications for down regulation, stimulation and ovulation induction. The subjects will be
randomized to study medication on the day of oocyte retrieval or the day following and will
continue treatment for up to 10 weeks. The subjects with a confirmed pregnancy will be
required to return to the clinic several times during the course of the 10 week treatment
period for serum pregnancy tests and transvaginal ultrasounds to monitor the pregnancy.
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