Pharmacokinetics of Progesterone in Pregnancy

Completed · Phase 1

Conditions studied: Progesterone

In brief

Pharmacokinetic analysis of 200mg vaginal progesterone suppository in women with singleton pregnancies between 18 0/7- 23 6/7 weeks' gestation

Key facts

Study ID

NCT03340701

Run by

Thomas Jefferson University

People needed

6

Starts

2017-11-06

Expected to finish

2018-06-30

Last updated by the study team

2020-02-20

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• ≥18 years old pregnant with singleton gestation 16 0/7 - 23 6/7 weeks
• pre-pregnancy BMI 20-40
• no history of prior preterm birth

You may not qualify if…

• history of an adverse reaction to progesterone
• contraindication to progesterone treatment including prior or active thrombus, active hepatic disease, known adverse reaction to progesterone
• medical comorbidity requiring medication including: hypertension, diabetes, substance abuse/methadone maintenance therapy, asthma, thyroid disease
• major fetal anomaly diagnosed on ultrasound or known chromosomal disorder
• multifetal gestation
• vaginal bleeding, preterm labor, premature rupture of membranes, or clinical chorioamnionitis, at the time of enrollment or on Day 1 of study
• any progesterone use of any form previously during the pregnancy
• active vaginitis
• Illicit substance use in pregnancy including cocaine, opiates, marijuana
• abnormal pap smear/+HPV on most recent pap smear
• known or suspected malignancy of the breast or genital organs
• cervical length ≤25mm

Where it is running

• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.